F-1 1 df1.htm FORM F-1 Form F-1
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As filed with the Securities and Exchange Commission on March 23, 2007

Registration No. 333-            

 


SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM F-1

REGISTRATION STATEMENT

UNDER THE SECURITIES ACT OF 1933

 


Simcere Pharmaceutical Group

(Exact name of registrant as specified in its charter)

Not Applicable

(Translation of Registrant’s name into English)

 

Cayman Islands   2834   Not Applicable

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

No. 699-18 Xuan Wu Avenue

Xuan Wu District, Nanjing

Jiangsu Province 210042

People’s Republic of China

(86) 25-8556-6666

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 


CT Corporation System

111 Eighth Avenue

New York, New York 10011

(212) 664-1666

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 


Copies to:

 

Leiming Chen

Simpson Thacher & Bartlett LLP

35th Floor, ICBC Tower

Three Garden Road

Central, Hong Kong

(852) 2514-7600

 

Alan Seem

Shearman & Sterling LLP

12th Floor, East Tower, Twin Towers

B-12 Jianguomenwai Dajie

Beijing, 100022

(86) (10) 5922-8000

 


Approximate date of commencement of proposed sale to the public:    As soon as practicable after the effective date of this registration statement

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  ¨

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨                    

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨                    

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earliest effective registration statement for the same offering.  ¨                    

 


CALCULATION OF REGISTRATION FEE

 


Title of each class of
securities to be registered(2)(3)
 

Proposed maximum

aggregate

offering price(1)

 

Amount of

registration fee

Ordinary Shares, par value $0.01 per ordinary share

  $ 120,000,000   $ 3,684

(1) Estimated solely for the purpose of determining the amount of registration fee in accordance with Rule 457(o) under the Securities Act of 1933.
(2) Includes (i) ordinary shares initially offered and sold outside the United States that may be resold from time to time in the United States either as part of their distribution or within 40 days after the later of the effective date of this registration statement and the date the shares are first bona fide offered to the public and (ii) ordinary shares that may be purchased by the underwriters pursuant to an over-allotment option. These ordinary shares are not being registered for the purposes of sales outside of the United States.
(3) American depositary shares issuable upon deposit of the ordinary shares registered hereby have been registered under a separate registration statement on Form F-6 (Registration No.333-            ). Each American depositary share represents              ordinary shares.

 


The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to such Section 8(a), may determine.

 



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The information in this preliminary prospectus is not complete and may be changed. Neither we nor the selling shareholders may sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

Subject to Completion. Dated                     , 2007

LOGO

Simcere Pharmaceutical Group

American Depositary Shares

Representing

Ordinary Shares

 


This is an initial public offering of American depositary shares, or ADSs, of Simcere Pharmaceutical Group, or Simcere Pharmaceutical.

Simcere Pharmaceutical is offering                      ADSs, and the selling shareholders identified in this prospectus are offering an additional                      ADSs. Simcere Pharmaceutical will not receive any of the proceeds from the sale of the                      ADSs being sold by the selling shareholders. Each ADS represents              ordinary shares, par value $0.01 per share. The ADSs are evidenced by American depositary receipts, or ADRs.

Prior to this offering, there has been no public market for our ADSs or our ordinary shares. It is currently estimated that the initial public offering price per ADS will be between $             and $            . Application has been made to have the ADSs traded on the New York Stock Exchange under the symbol “SCR.”

See “ Risk Factors” beginning on page 12 to read about risks you should consider before buying the ADSs.

 


Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

 


 

          Per ADS                 Total        

Initial public offering price

   $                         $                     

Underwriting discount

   $      $  

Proceeds, before expenses, to Simcere Pharmaceutical

   $      $  

Proceeds, before expenses, to the selling shareholders

   $      $  

To the extent the underwriters sell more than                      ADSs, the underwriters have an option to purchase up to an additional                      ADSs from Simcere Pharmaceutical and up to an aggregate of                      ADSs from the selling shareholders at the initial public offering price less the underwriting discount.

 


The underwriters expect to deliver the ADSs evidenced by the ADRs against payment in U.S. dollars in New York, New York on                     , 2007.

 


Goldman Sachs (Asia) L.L.C.

 


Prospectus dated                     , 2007.


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Table of Contents

TABLE OF CONTENTS

 

     Page

Prospectus Summary

   1

Risk Factors

   12

Special Note Regarding Forward-Looking Statements

   40

Use of Proceeds

   42

Dividend Policy

   45

Capitalization

   46

Dilution

   47

Exchange Rate Information

   49

Enforceability of Civil Liabilities

   50

Selected Consolidated Financial Data

   52

Recent Developments

   54

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   55

Our Industry

   82

Business

   87

Regulation of Our Industry

   109

Management

   120

Principal and Selling Shareholders

   128

Related Party Transactions

   130

Description of Share Capital

   131

Description of American Depositary Shares

   141

Shares Eligible for Future Sale

   148

Taxation

   150

Underwriting

   155

Legal Matters

   161

Experts

   161

Where You Can Find Additional Information

   162

Index to Consolidated Financial Statements

   F-1

Index to Unaudited Pro Forma Consolidated Financial Information

   P-1

 

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PROSPECTUS SUMMARY

The following summary is qualified in its entirety by, and should be read in conjunction with, the more detailed information and financial statements appearing elsewhere in this prospectus. In addition to this summary, we urge you to read the entire prospectus carefully, especially the risks of investing in the ADSs discussed under “Risk Factors”, before deciding whether to buy our ADSs.

Our Business

We are a leading manufacturer and supplier of branded generic pharmaceuticals in the fast growing China market. We have recently focused our strategy on the development of first-to-market generic and innovative pharmaceuticals, and have introduced a first-to-market generic anti-stroke medication under the brand name Bicun, and an innovative anti-cancer medication under the brand name Endu, also known as Endostar. We currently manufacture and sell 35 pharmaceutical products, including antibiotics, an anti-cancer medication and an anti-stroke medication, and are the exclusive distributor of three additional pharmaceuticals that are marketed under our brand names, including anti-inflammatory pain relievers. In addition, we have obtained approvals from the PRC State Food and Drug Administration, or the SFDA, to manufacture and sell 100 other products. As of March 20, 2007, we also had 12 product candidates in various stages of development, including treatments for cancer, cerebrovascular diseases, infections, rheumatoid arthritis, nasal allergies, and nausea and vomiting associated with chemotherapy.

Our innovative anti-cancer drug Endu has been granted an invention patent in China and was the first recombinant human endostatin injection approved for sale in China. Recombinant human endostatin is a genetically engineered protein that interferes with the growth of blood vessels to a tumor, thereby starving and preventing the growth of tumor cells. Our generic anti-stroke medication, Bicun, was the first edaravone injection, a type of neuroprotective pharmaceutical compound, approved for sale in China and we estimate that Bicun held the leading market share of more than 90.0% in terms of total edaravone injections sold in China in 2005, based on the market research conducted by IMS Health, a provider of market intelligence to the pharmaceutical and healthcare industry. Our generic amoxicillin granule antibiotic is marketed under the brand name Zailin, which was recognized as a “China Well-Known Trademark” in February 2004. In 2005, Zailin had a leading market share of 55.5% and 31.3% of all amoxicillin granules sold in hospitals and retail outlets in China, respectively, based on the information provided by the Southern Pharmaceutical Economic Research Institute, a market research agency that specializes in the pharmaceutical industry in China.

We commenced operations in March 1995 as a distributor of pharmaceutical products, and since then have established an extensive distribution network in China that we now use to market, sell and distribute our own pharmaceutical products. We sell our products exclusively to regional distributors, who then sell them to local distributors, hospitals and retail pharmacies throughout China. Our marketing team leverages the reputation of our Simcere brand name and our well-known branded pharmaceuticals to cross-sell our other pharmaceuticals. We also have dedicated brand management, market research and sales support teams to further enhance the effectiveness of these marketing efforts.

We employ a market-oriented approach to research and development and focus our efforts on branded generic pharmaceuticals that have the potential for gaining widespread market acceptance or are the first generic version on the market. We concentrate our research and development efforts on the treatment of diseases with high incidence and/or mortality rates and for which there is a clear demand for more effective pharmacotherapy, such as cancer and cerebrovascular and infectious diseases. Through our research and development efforts, we have introduced to the China market a sizable portfolio of branded generic pharmaceuticals with significant market potential.

 

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We have experienced significant growth in our business in recent years. Our total revenues increased from RMB564.2 million in 2004 to RMB737.0 million in 2005 and to RMB950.6 million ($121.8 million) in 2006, representing a compound annual growth rate, or CAGR, of 29.8% from 2004 to 2006. Revenues from each of our top three branded pharmaceuticals, Bicun, Zailin and Yingtaiqing (for inflammation and pain), have exceeded RMB100.0 million ($12.8 million) in 2006, which we believe is evidence of wide market acceptance of these products in the China market. Our net income increased from RMB46.2 million in 2004 to RMB102.7 million in 2005 and to RMB172.3 million ($22.1 million) in 2006, representing a CAGR of 93.1% from 2004 to 2006.

Our Industry

With approximately one-fifth of the world’s population and a fast-growing gross domestic product, China presents significant potential for the pharmaceutical industry. According to the Freedonia Group, an international industry study and database company, pharmaceutical demand in China reached RMB198.0 billion ($25.4 billion) in 2005, representing a growth of 12.1% annually since 2000. The Freedonia Group expects the total pharmaceutical expenditure in China to grow at a CAGR of 13.6% between 2005 and 2010. Such growth rate is significantly higher than the growth rate for the pharmaceutical industry in the rest of the world, which is projected to be at a CAGR of 5.0% to 8.0% between 2004 and 2009 according to IMS Health. We believe the significant growth potential of the pharmaceutical market in China is due to the following factors:

 

  Ÿ  

Increasing Disposable Income and Spending on Pharmaceuticals.    China’s fast growing economy has led to an increase in disposable income and improvement of living standards, which has made pharmaceutical products more affordable and accessible and spending on pharmaceuticals more common.

 

  Ÿ  

Aging Population and Lifestyle-Related Disorders.    The prevalence of several chronic diseases such as arthritis, cardiovascular diseases and cancer is expected to increase in China as a result of an aging population. In addition, as living standards in China continue to increase, many lifestyle-related illnesses are also growing rapidly, which is expected to contribute to spending on pharmaceutical products.

 

  Ÿ  

Government Support of the Pharmaceutical Industry.    The PRC government has supported the growth of the pharmaceutical industry with a series of initiatives, including encouraging foreign investment in the pharmaceutical industry, raising the ratio of overall research and development investment to gross domestic product and shutting down factories that manufacture counterfeit pharmaceutical products.

 

  Ÿ  

Cost Efficiency in Developing New Pharmaceutical Products.    China offers lower research and development costs and clinical trial costs compared to western countries. According to the China National Center for Biotechnology Development, the cost of bringing a new pharmaceutical product to market can be as little as $5.9 million in China, as compared to the estimated $800.0 million in western countries.

 

  Ÿ  

Increased Availability of Funding Under the National Medical Insurance Program and the Inclusion of More Pharmaceuticals in China in the National and Provincial Medical Insurance Catalogs.    The PRC government has increased the availability of funding for medical insurance coverage and included more pharmaceuticals in the PRC national and provincial basic medical and work-related injury insurance catalogs, or the Medical Insurance Catalogs. As patients’ choices of medicines are often driven by affordability and accessibility, the inclusion of a medicine in the Medical Insurance Catalogs can substantially improve sales of such medicine.

 

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  Ÿ  

Fragmentation of the Pharmaceutical Industry and the Trend for Consolidation.    The pharmaceutical industry in China is highly fragmented and competitive, with 4,738 pharmaceutical manufacturers as of December 31, 2004 according to the PRC National Development and Reform Commission, or the NDRC, and with no single manufacturer holding more than 4.0% of the market according to the Freedonia Group. The fragmentation of the pharmaceutical industry provides an opportunity for consolidation, as only manufacturers with effective national-wide distribution capabilities, relatively strong research and development capabilities and large-scale production are expected to thrive.

Our Competitive Strengths

We believe that the following competitive strengths will enable us to take advantage of the rapid growth of the pharmaceutical market in China and to compete effectively:

 

  Ÿ  

a strong portfolio of branded products supported by proven commercialization capabilities;

 

  Ÿ  

strong growth potential of our innovative pharmaceutical Endu;

 

  Ÿ  

effective research and development strategy and product acquisition capability leading to an orderly pipeline of products that will contribute to future growth;

 

  Ÿ  

significant marketing and distribution experience and an extensive distribution network; and

 

  Ÿ  

an experienced management team with proven ability to lead our growth.

Our Strategies

Our objectives are to be the market leader for the development and manufacturing of innovative pharmaceuticals and the introduction of new generic pharmaceuticals to the China market. We intend to grow our business by pursuing the following strategies:

 

  Ÿ  

focus on both the development of branded generic pharmaceuticals as well as the research and development of innovative pharmaceuticals, while accelerating the time-to-market of these products;

 

  Ÿ  

concentrate our marketing and promotional efforts on pharmaceuticals with large growth potential;

 

  Ÿ  

expand through acquisitions as well as through organic growth; and

 

  Ÿ  

develop collaborative relationships with international pharmaceutical and biotechnology companies.

Our Challenges

We believe that the following are some of the major risks and uncertainties that may materially affect us:

 

  Ÿ  

difficulties in achieving and maintaining widespread market acceptance for our products and product candidates;

 

  Ÿ  

the sufficiency of our existing and future intellectual property right protections, our failure to protect our intellectual property rights and the high costs in defending our intellectual property rights in potential litigation;

 

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  Ÿ  

difficulties in successfully developing future pharmaceutical products;

 

  Ÿ  

our ability to obtain regulatory approval for pharmaceuticals that we develop; and

 

  Ÿ  

our inability to manage effectively the expansion of our operations.

See “Risk Factors” and other information included in this prospectus for a discussion of these risks.

Corporate Structure

Our predecessor entity, Hainan Simcere Investment Group Ltd., or Simcere Investment, was a PRC company that held a group of pharmaceutical companies that develops, manufactures and markets a range of branded generic and innovative pharmaceuticals. To raise capital from investors outside of China, we established State Good Group Limited, or SGG, in the British Virgin Islands on October 12, 2005. Our operating subsidiaries were transferred to SGG in March 2006 as part of a series of corporate reorganization activities. In anticipation of this initial public offering, we incorporated Simcere Pharmaceutical Group in the Cayman Islands as a listing vehicle on August 4, 2006. Simcere Pharmaceutical Group became our ultimate holding company when it issued ordinary shares to existing shareholders of SGG on September 29, 2006, in exchange for the respective ordinary shares that these shareholders held in SGG.

As the transfer of our operating subsidiaries to SGG was completed for the sole purpose of establishing a corporate structure to facilitate the raising of capital from investors outside of the PRC, and the transfer of SGG to Simcere Pharmaceutical Group was completed solely for the purpose of this initial public offering, these transactions have been accounted for in a manner similar to a pooling-of-interests in our consolidated financial statements. Accordingly, the assets and liabilities transferred to us have been stated at their historical carrying amounts and the consolidated financial statements as of and for the years ended December 31, 2004, 2005 and 2006, present our financial condition and results of operations as if our operating subsidiaries were transferred to us as of the beginning of the earliest period presented.

We conduct substantially all of our operations through the following operating subsidiaries in China:

 

  Ÿ  

Simcere Pharmaceutical Co., Ltd., or Hainan Simcere, is our wholly owned subsidiary that engages in the manufacturing of pharmaceutical products. Hainan Simcere is currently authorized to manufacture 56 pharmaceutical products;

 

  Ÿ  

Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd., or Nanjing Simcere, is our wholly owned subsidiary that engages in the manufacturing of pharmaceutical products. Nanjing Simcere is currently authorized to manufacture 78 pharmaceutical products;

 

  Ÿ  

Jiangsu Simcere Pharmaceutical Co., Ltd., or Jiangsu Simcere, and Shanghai Simcere Pharmaceutical Co., Ltd., or Shanghai Simcere, are both our wholly owned subsidiaries that engage in the marketing, sales and distribution of pharmaceutical products;

 

  Ÿ  

Jiangsu Simcere Pharmaceutical R&D Co., Ltd., or Simcere Research, is our wholly owned subsidiary and engages in the research and development of pharmaceutical products;

 

  Ÿ  

Sichuan Zigong Yirong Industrial Co., Ltd., or Sichuan Simcere, is our wholly owned subsidiary that owns the mining right to a smectite mine in Sichuan Province and engages in the extraction of smectite, a raw material used for the manufacturing of one of our pharmaceutical products;

 

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  Ÿ  

Hainan Qitian Pharmaceutical Co., Ltd., or Qitian Simcere, is our wholly owned subsidiary that engages in the processing and refinement of smectite; and

 

  Ÿ  

Shandong Simcere Medgenn Bio-Pharmaceutical Co., Ltd., formerly Yantai Medgenn Co., Ltd., or Yantai Medgenn, is our 80.0%-owned subsidiary that engages in the research, development, manufacturing and sale of Endu in China. We completed the acquisition of 80.0% of the equity interest of Yantai Medgenn in September 2006. In addition, Yantai Medgenn owns a 40.0% equity interest in Medgenn (Hong Kong) Co., Ltd., or Hong Kong Medgenn that was acquired for no cash consideration. Hong Kong Medgenn has the exclusive right to engage in the development and sale of Endu in any jurisdiction outside of the PRC until February 10, 2015. Hong Kong Medgenn has no paid-in capital and has not conducted any operations to date.

The following diagram illustrates our corporate structure and the place of organization of each of our subsidiaries as of the date of this prospectus.

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Corporate Information

Our principal executive offices are located at No. 699-18 Xuan Wu Avenue, Xuan Wu District, Nanjing, Jiangsu Province 210042, People’s Republic of China. Our telephone number at this address is (86) 25-8556-6666 and our fax number is (86) 25-8547-6400.

Investor inquiries should be directed to us at the address and telephone number of our principal executive offices set forth above. Our website is www.simcere.com. The information contained on our website is not part of this prospectus. Our agent for service of process in the United States is CT Corporation System, located at 111 Eighth Avenue, New York, New York 10011.

Conventions That Apply to This Prospectus

Unless otherwise indicated:

 

  Ÿ  

“$,” “USD” and “U.S. dollars” refer to the legal currency of the United States;

 

  Ÿ  

“ADRs” refer to the American depositary receipts, which, if issued, evidence our ADSs;

 

  Ÿ  

“ADSs” refer to our American depositary shares, each of which represents              ordinary shares;

 

  Ÿ  

“China” and the “PRC” refer to the People’s Republic of China, excluding, for the purposes of this prospectus only, Taiwan and the special administrative regions of Hong Kong and Macau;

 

  Ÿ  

“ordinary shares” refer to our ordinary shares, par value $0.01 per share;

 

  Ÿ  

“RMB” and “Renminbi” refer to the legal currency of China; and

 

  Ÿ  

“we,” “us,” “our company” and “our” refer to Simcere Pharmaceutical Group, its predecessor entities and its consolidated subsidiaries.

Unless otherwise indicated, information in this prospectus assumes that the underwriters do not exercise their over-allotment option to purchase additional ADSs.

This prospectus contains translations of certain Renminbi amounts into U.S. dollars at specified rates. All translations from Renminbi to U.S. dollars were made at the noon buying rate in The City of New York for cable transfers in Renminbi per U.S. dollar as certified for customs purposes by the Federal Reserve Bank of New York, or the noon buying rate. Unless otherwise stated, the translation of Renminbi into U.S. dollars has been made at the noon buying rate in effect on December 29, 2006, which was RMB7.8041 to $1.00. We make no representation that the Renminbi or U.S. dollar amounts referred to in this prospectus could have been or could be converted into U.S. dollars or Renminbi, as the case may be, at any particular rate or at all. See “Risk Factors—Risk Related to Doing Business in China—Fluctuation in the value of the Renminbi may have a material adverse effect on your investment.” On March 20, 2007, the noon buying rate was RMB7.7320 to $1.00.

 

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THE OFFERING

 

Price per ADS

We currently estimate that the initial public offering price will be between $             and $             per ADS

 

ADS offered by us

             ADSs

 

ADS offered by the selling shareholders

             ADSs

 

Total

             ADSs

 

ADSs outstanding immediately after the offering

             ADSs

 

Ordinary shares outstanding immediately after the offering

             ordinary shares, excluding ordinary shares issuable upon the exercise of outstanding share options and ordinary shares reserved for issuance under our 2006 equity incentive plan.

 

The ADSs

Each ADS represents              ordinary shares, par value $0.01 per share. The ADSs will be evidenced by a global American Depositary Receipt.

 

 

The depositary will be the holder of the ordinary shares underlying the ADSs and you will have the rights of an ADS holder as provided in the deposit agreement among us, the depositary and owners and beneficial owners of ADSs from time to time.

 

 

You may surrender your ADSs to the depositary to withdraw the ordinary shares underlying your ADSs. The depositary will charge you a fee for such an exchange.

 

 

We may amend or terminate the deposit agreement for any reason without your consent. If an amendment becomes effective, you will be bound by the deposit agreement as amended if you continue to hold your ADSs.

 

 

To better understand the terms of the ADSs, you should carefully read the section in this prospectus entitled “Description of American Depositary Shares.” We also encourage you to read the deposit agreement, which is an exhibit to the registration statement that includes this prospectus.

 

Depositary

The Bank of New York

 

Options to purchase additional ADSs

We and the selling shareholders have granted the underwriters an option, exercisable within 30 days from the date of this prospectus, to purchase up to an aggregate of              additional ADSs.

 

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Use of proceeds

We estimate that we will receive net proceeds from this offering of approximately $             million assuming an initial public offering price of $            , which is the midpoint of the estimated public offering price range, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds we receive from this offering for the following purposes:

 

   

approximately $52.0 million to fund our research and development efforts, including approximately $35.0 million to fund joint pre-clinical studies and clinical trials in China with international pharmaceutical and biotechnology companies to develop innovative pharmaceuticals for the China market, approximately $13.0 million to fund the research and development of potential indications for Endu, the Phase IV clinical trials for Endu and the improvement of delivery mechanisms or dosage formulations for Endu, and approximately $4.0 million to purchase research equipment;

 

   

approximately $30.0 million to repay certain of our outstanding short-term bank borrowings;

 

   

approximately $14.0 million to fund our GMP-certified production facilities, including approximately $9.0 million to build additional GMP-certified production facilities and purchase additional production equipment to expand our production capacity of Endu, and approximately $5.0 million to revamp our existing production facilities and to purchase additional equipment to sustain compliance with GMP requirements; and

 

   

approximately $13.0 million to expand our marketing force and strengthen our marketing efforts, including initiating additional promotional and educational campaigns targeting hospitals, healthcare practitioners, pharmacies, patients and the general public to increase awareness of our products and to increase the use of print and television advertisements and other promotional methods to promote our brand names.

 

 

We may also use the remaining portion of the net proceeds we receive from this offering for other general corporate purposes and for potential acquisitions of, or investments in, products, product candidates, businesses and technologies that we believe will complement our current operations and our expansion strategies. See “Use of Proceeds” for additional information.

 

 

We will not receive any of the proceeds from the sales of the ADSs by the selling shareholders.

 

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Risk factors

See “Risk Factors” and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in the ADSs.

 

New York Stock Exchange trading symbol

SCR

 

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SUMMARY CONSOLIDATED FINANCIAL DATA

The following summary consolidated statements of income and other consolidated financial data for the years ended December 31, 2004, 2005 and 2006, other than the earnings per ADS data, and the consolidated balance sheet data as of December 31, 2005 and 2006 have been derived from our audited consolidated financial statements included elsewhere in this prospectus. You should read the summary consolidated financial data in conjunction with those financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus. Our consolidated financial statements are prepared and presented in accordance with United States generally accepted accounting principles, or U.S. GAAP. Our historical results do not necessarily indicate our results expected for any future periods.

 

    Year Ended December 31,  
        2004             2005             2006             2006      
    RMB     RMB     RMB     USD  
    (in thousands, except share, per share and per ADS data)  

Consolidated Statements of Income Data

       

Total revenues(1)

  564,198     737,014     950,606     121,809  

Gross profit

  410,403     565,940     760,046     97,391  

Research and development expenses

  (19,907 )   (16,288 )   (34,289 )   (4,394 )

Sales, marketing and distribution expenses

  (230,865 )   (312,426 )   (442,757 )   (56,734 )

General and administrative expenses

  (77,593 )   (87,139 )   (98,249 )   (12,589 )

Income from operations

  82,038     150,087     184,751     23,674  

Net income(2)

  46,245     102,745     172,258     22,072  

Earnings per share — basic and diluted

  0.67     1.49     1.86     0.24  

Earnings per ADS — basic and diluted

       

Weighted average number of shares

  69,000,000     69,000,000     92,695,890     92,695,890  

(1) Total revenues include product revenues and other revenues, which is comprised of value-added tax, or VAT, refunds on sales of our products.
(2) In March 2006, certain of our operating subsidiaries became eligible for certain exemptions from income tax. In September 2006, we acquired 80.0% of the equity interest of Yantai Medgenn, which is also eligible for such tax exemption. The effect of the income tax exemptions on our earnings per share in 2006 was RMB0.42 ($0.05). Prior to 2006, there was no tax exemption in place. Without these exemptions, our basic and diluted earnings per share in 2006 would have been RMB1.44 ($0.19).

 

     Year Ended December 31,
             2004                    2005                    2006        
     (in percentages)

Other Consolidated Financial Data

        

Gross margin

   72.7    76.8    80.0

Operating margin

   14.5    20.4    19.5

Net margin

   8.2    13.9    18.2

 

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     As of December 31,
     2005    2006    2006
         RMB            RMB            USD    
     (in thousands)

Consolidated Balance Sheet Data

        

Cash

   90,060    106,027    13,586

Accounts receivable, net of allowance for doubtful accounts

   83,393    61,723    7,909

Inventories

   40,293    39,483    5,059

Amounts due from related parties

   85,575    434    55

Total current assets

   391,461    411,429    52,720

Property, plant and equipment, less accumulated depreciation

   125,365    267,054    34,220

Intangible assets, net

   15,731    163,148    20,905

Goodwill

   13,814    100,634    12,895

Total assets

   621,227    1,034,547    132,565

Short-term bank loans and borrowings

   171,000    333,000    42,670

Amounts due to related parties

   78,153    1,352    173

Total current liabilities

   421,185    568,173    72,805

Total shareholders’ equity

   192,537    442,740    56,732

 

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RISK FACTORS

An investment in our ADSs involves significant risks. You should carefully consider the risks described below and the other information in this prospectus, including our consolidated financial statements and related notes, before you decide to buy our ADSs. If any of the following risks actually occur, our business, prospects, financial condition and results of operations could be materially harmed, the trading price of our ADSs could decline and you could lose all or part of your investment.

Risks Related to Our Company

Our products and product candidates may not achieve or maintain widespread market acceptance.

Success of our products is highly dependent on the needs and preferences of healthcare practitioners and patients and market acceptance, and we may not achieve or maintain widespread market acceptance of our products or product candidates among healthcare practitioners and patients. We believe that market acceptance of our products will depend on many factors, including:

 

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the perceived advantages of our products over competing products and the availability and success of competing products;

 

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the effectiveness of our sales and marketing efforts;

 

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the safety and efficacy of our products and the prevalence and severity of adverse side effects, if any;

 

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our product pricing and cost effectiveness;

 

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publicity concerning our products, product candidates or competing products;

 

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whether or not patients routinely use our products, refill prescriptions and purchase additional products;

 

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our ability to respond to changes in healthcare practitioner and patient preferences; and

 

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the continued inclusion of our products in the Medical Insurance Catalogs.

If our products fail to achieve or maintain market acceptance, or if new products are introduced by others that are more favorably received than our products, are more cost effective or otherwise render our products obsolete, we may experience a decline in the demand for our products. If we are unable to market and sell our products successfully, our business, financial condition, results of operation and future growth would be adversely affected.

Our trademarks, patents and other non-patented intellectual property are valuable assets and if we are unable to protect them from infringement, our business prospects may be harmed.

As our own brand of generic products constitutes a large portion of our sales, we consider our trademarks to be valuable assets. Under PRC law, we have the exclusive right to use a trademark for products and services for which such trademark has been registered with the PRC Trademark Office of State Administration for Industry and Commerce. However, our efforts to defend our trademarks may be unsuccessful against competitors or other violating entities and we may not have adequate remedies for any breach. Our commercial success will also depend in part on our obtaining and maintaining patent and trade secret protection of our technologies, product candidates and products as well as successfully defending our patents against third-party challenges. We will only be able to protect our technologies, product candidates and products from unauthorized use by third parties to the extent that valid and enforceable patents or trade secrets cover them. In the event that our issued

 

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patents and our applications do not adequately describe, enable or otherwise provide coverage of our technologies, product candidates and products, we would not be able to exclude others from developing or commercializing these technologies, product candidates and products. Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.

The patent positions of pharmaceutical companies can be highly uncertain and involve complex legal and factual questions. The patent situation outside of China may be more complex. Changes in either the patent laws or in interpretations of patent laws in China or other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the scope of claims that may be allowed or enforced in our patents or in third-party patents. For example:

 

  Ÿ  

we might not have been the first to make the inventions covered by each of our pending patent applications and issued patents;

 

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we might not have been the first to file patent applications for these inventions;

 

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others may independently develop similar or alternative technologies or duplicate our technologies without infringing our intellectual property rights;

 

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one or more of our pending patent applications may not result in issued patents;

 

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our issued patents may not provide a basis for commercially viable products, may not provide us with any competitive advantages, or may be challenged and invalidated by third parties;

 

  Ÿ  

we may not develop additional proprietary technologies or product candidates that are patentable; and

 

  Ÿ  

the patents of others may prevent us from developing or commercializing our product candidates.

We also rely on trade secrets to protect our technology, especially where we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we use reasonable efforts to protect our trade secrets, our research partners’ employees, consultants, contractors or scientific and other advisors may unintentionally or willfully disclose our information to competitors. In addition, confidentiality agreements, if any, executed by the foregoing persons may not be enforceable or provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets, our enforcement efforts would be expensive and time-consuming, and the outcome would be unpredictable. In addition, if our competitors independently develop information that is equivalent to our trade secrets, it will be more difficult for us to enforce our rights and our business could be harmed.

If we are not able to obtain and defend our patents or trade secrets, we will not be able to exclude competitors from developing or marketing competing products using the relevant technologies or processes, thereby adversely affecting our competitiveness.

The existence of a patent may not necessarily protect us from competition as our patent may be challenged, invalidated or held unenforceable. We may also be found to infringe the patents of others.

The existence of a patent may not necessarily protect us from competition, as any patent issued may be challenged, invalidated, or held unenforceable. Competitors may successfully challenge our patents, produce similar products that do not infringe our patents or produce products in countries that do not recognize our patents. The occurrence of any of these events could hurt our competitive position and decrease our revenues from product sales and/or licensing.

 

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In addition, even if we own patents, this does not provide assurance that the manufacture, sale or use of our patented products does not infringe the patent rights of another. Because patent applications can take many years to approve and issue, there may be pending applications, known or unknown to us, that may later result in issued patents that our technologies, product candidates or products may infringe. Specifically, under PRC patent law, the term of patent protection starts from the date the patent was filed, instead of the date it was issued as is the case in many jurisdictions. Therefore our priority in any PRC patents may be defeated by third-party patents issued on a later date if the applications for such patents were filed prior to our own, and the technologies underlying such patents are the same or substantially similar to ours. In such case, a third party with an earlier application may force us to pay to license its patented technology, sue us for patent infringement and/or challenge the validity of our patents. If a third party sues us for infringement, the suit will divert substantial management time and resources, regardless of whether we are ultimately successful. Further, we may be liable for monetary damages and/or forced to redesign, if possible, our technology to avoid the infringement.

Litigation to protect our intellectual property rights or defend against third-party allegations of infringement may be costly.

We may encounter future litigation by third parties based on claims that our products or activities infringe the intellectual property rights of others or that we have misappropriated the trade secrets of others. We may also initiate lawsuits to defend the ownership or inventorship of our inventions. It is difficult, if not impossible, to predict how such disputes would be resolved. The defense and prosecution of intellectual property rights are costly and divert technical and management personnel from their normal responsibilities. We may not prevail in any of such litigation or proceedings. An adverse determination of any litigation or proceedings against us, resulting in a finding of non-infringement by others or invalidity of our patents, may result in the sale by competitors of generic substitutes of our products. In addition, a determination that we have infringed on the intellectual property rights of another may require us to do one or more of the following:

 

  Ÿ  

pay monetary damages to settle the results of such adverse determination, which could adversely affect our business, financial condition and results of operations;

 

  Ÿ  

cease selling, incorporating or using any of our products that incorporate the challenged intellectual property, which would adversely affect our revenue or costs, or both;

 

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obtain a license from the holder of the infringed intellectual property right, which might be costly or might not be available on reasonable terms, or at all; or

 

  Ÿ  

redesign our products to make them non-infringing, which would be costly and time-consuming and may require additional clinical trials, or may not be possible at all.

While we currently know of no actual or threatened claim of infringement that would be material to us, there can be no assurance that such a claim will not be asserted. If such a claim is asserted, there can be no assurance that the resolution of the claim would permit us to continue producing the product in question on commercially reasonable terms. In addition, there is a risk that some of our confidential information could be compromised by disclosure during intellectual property litigation. Furthermore, there could be public announcements throughout the course of intellectual property litigation or proceedings as to the results of hearings, motions or other interim proceedings or developments in the litigation. If securities analysts or investors perceive these results to be negative, there could be a substantial negative effect on the trading price of our ADSs.

 

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Most of our products are branded generics that can be manufactured and sold by other pharmaceutical manufacturers in China once the relevant protection or monitoring periods, if any, elapse.

Most of our products are branded generic pharmaceuticals and are not protected by intellectual property rights. As a result, other pharmaceutical companies may sell equivalent products at a lower cost, and this might result in a commensurate loss in sales of our branded generic products. Certain of our generic products are subject to a protection or monitoring period. During such period, the SFDA will not accept applications for new medicine certificates for the same product by other pharmaceutical companies or approve the production or import of the same product by other pharmaceutical companies. Once such protection or monitoring periods expire, other manufacturers may obtain relevant production approvals and will be entitled to sell generic pharmaceutical products with similar formulae or production methods in China. The maximum monitoring period currently granted by the SFDA is five years. Prior to September 15, 2002, however, the SFDA would grant what is known as a “protection period” to a new medicine instead of a monitoring period. See “Regulation of Our Industry—Approval and Registration of Pharmaceutical Products.” The maximum protection period granted by the SFDA was eight years prior to April 1999, but was later increased to 12 years. As of March 20, 2007, two of the pharmaceutical products we currently manufacture and sell, Bicun and Zaichang, are under a protection or a monitoring period, and the respective protection or monitoring period is to expire on December 30, 2007 and March 13, 2013, respectively. If other pharmaceutical companies sell pharmaceutical products that are similar to our unprotected products or our protected products for which the relevant protection or monitoring period has expired, we may face additional competition and our business and profitability may be adversely affected.

We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

Certain of our employees and consultants were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors, or at universities or other research institutions. Although no claims against us are currently pending, we may be subject to claims that these employees, consultants or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to our management. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could delay or prevent us from commercializing one or more of our product candidates.

Our future research and development projects may not be successful.

The successful development of pharmaceutical products can be affected by many factors. Products that appear to be promising at their early phases of research and development may fail to be commercialized for various reasons, including the failure to obtain the necessary regulatory approvals. In addition, the research and development cycle for new products for which we may obtain an approval certificate is long. The process of conducting basic research and various stages of tests and trials of a new product before obtaining an approval certificate and commercializing the product may require ten years or longer. Many of our product candidates are in the early stages of pre-clinical study and clinical trial and we must conduct significant additional clinical trials before we can seek the regulatory approvals necessary to begin commercial production and sales of these products. There is no assurance that our future research and development projects will be successful or completed within the anticipated time frame or budget or that we will receive the necessary approvals from relevant

 

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authorities for the production of these newly developed products, or that these newly developed products will achieve commercial success. Even if such products can be successfully commercialized, they may not achieve the level of market acceptance that we expect.

In addition, the pharmaceutical industry is characterized by rapid changes in technology, constant enhancement of industrial know-how and frequent emergence of new products. Future technological improvements and continual product developments in the pharmaceutical market may render our existing products obsolete or affect their viability and competitiveness. Therefore, our future success will largely depend on our research and development capability, including our ability to improve our existing products, diversify our product range and develop new and competitively priced products that can meet the requirements of the changing market. Should we fail to respond to these frequent technological advances by improving our existing products or developing new products in a timely manner or these products do not achieve a desirable level of market acceptance, our business and profitability will be materially and adversely affected.

We rely on research institutions and universities in China for the research and development of new products and any failure of our research partners to meet our timing and quality standards or our failure to continue such collaborative arrangement or enter into such new arrangements could adversely affect our ability to develop new pharmaceuticals and our overall business prospects.

Our business strategy includes collaborating with third parties for research and development of new products. We rely on long-term cooperative relationships with a number of research institutions and universities in China, including Tsinghua University and the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences. These research institutions and universities have collaborated with us in a number of research projects and certain of our products that have obtained approval certificates were developed by us together with our research partners. At present, several research institutions and universities are working with us on various research and development projects. Any failure of our research partners to meet the required quality standards and timetables set in their research agreements with us, or our inability to enter into additional research agreements with these research partners on terms acceptable to us in the future, may have an adverse effect on our ability to develop new medicines and on our business prospects. In addition, the growth of our business and development of new products may require that we seek additional collaborative partners. We cannot assure you that we will be able to enter into agreements with collaborative partners on terms acceptable to us. Our inability to enter into such agreements or our failure to maintain such arrangements could limit the number of new products that we could develop and ultimately decrease our sources of future revenue.

We may not be able to obtain regulatory approval for any of the products resulting from our development efforts and failure to obtain these approvals could materially harm our business.

All new medicines must be approved by the SFDA before they can be marketed and sold in China. The SFDA requires successful completion of clinical trials and demonstrated manufacturing capability before it grants approval. Clinical trials are expensive and their results are uncertain. It often takes a number of years before a medicine can be ultimately approved by the SFDA. In addition, the SFDA and other regulatory authorities may apply new standards for safety, manufacturing, packaging, and distribution of future product candidates. Complying with such standards may be time-consuming and expensive and could result in delays in obtaining SFDA approval for our future product candidates, or possibly preclude us from obtaining SFDA approval altogether. Furthermore, our future products may not be effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude us from obtaining regulatory approval or prevent or limit commercial use. The SFDA and other regulatory

 

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authorities may not approve the products that we develop and even if we do obtain regulatory approvals, such regulatory approvals may be subject to limitations on the indicated uses for which we may market a product, which may limit the size of the market for such product.

Our marketing activities are critical to the success of our products, and if we fail to grow our marketing capabilities or maintain adequate spending on marketing activities, the market share of our products and our brand name and product reputation would be materially adversely affected.

Most of our products are branded generic pharmaceuticals and the success and lifespan of our products are dependent on our efforts in the marketing of our products. Our marketing professionals regularly visit hospitals, clinics and pharmacies to explain the therapeutic value of our pharmaceuticals, to keep healthcare professionals up to date as to any developments relating to our pharmaceuticals. We organize in-person product presentations, conferences and seminars for physicians and other healthcare professionals and participate in trade shows to generate market awareness of our existing and new prescription pharmaceuticals. We are also engaged in advertising and educational campaigns on various media to educate the public as to our pharmaceuticals. These various marketing activities are critical to the success of our products. However, we cannot assure you that our current and planned spending on marketing activities will be adequate to support our future growth. Any factors adversely affecting our ability to grow our marketing capabilities or our ability to maintain adequate spending on marketing activities will have an adverse affect on the market share of our products and the brand name and reputation of our products, which may result in decreased demand for our products and negatively affect our business and results of operations.

We may not be successful in competing with other manufacturers of pharmaceuticals in the tender processes for the purchase of medicines by state-owned and state-controlled hospitals.

A substantial portion of the products we sell to our distributor customers are then sold to hospitals owned and controlled by counties or higher level government authorities in China. These hospitals must implement collective tender processes for the purchase of medicines listed in the Medical Insurance Catalogs and medicines that are consumed in large volumes and commonly prescribed for clinical uses. During a collective tender process, the hospitals will establish a committee consisting of recognized pharmaceutical experts. The committee will assess the bids submitted by the pharmaceutical manufacturers, taking into consideration, among other things, the quality and price of the medicine and the service and reputation of the manufacturers. For the same type of pharmaceutical, the committee usually selects from among two to three different brands. Only pharmaceuticals that have won in the collective tender processes may be purchased by these hospitals. The collective tender process for pharmaceuticals with the same chemical composition must be conducted at least annually, and pharmaceuticals that have won in the collective tender processes previously must participate and win in the collective tender processes in the following period before new purchase orders can be issued. If we are unable to win purchase contracts through the collective tender processes in which we decide to participate, we will lose market share to our competitors, and our revenue and profitability will be adversely affected.

We may not be able to successfully identify and acquire new products or businesses.

In addition to our own research and development efforts, our growth strategy also relies on our acquisitions of new product candidates, products or businesses from third parties. Any future growth through acquisitions will be dependent upon the continued availability of suitable acquisition candidates at favorable prices and upon advantageous terms and conditions. Even if such opportunities are present, we may not be able to successfully identify such acquisition target. Moreover, other companies, many of which may have substantially greater financial, marketing and sales resources, are competing with us for the right to acquire such product candidates, products or businesses.

 

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If an acquisition candidate is identified, the third parties with which we seek to cooperate may not select us as a potential partner or we may not be able to enter into arrangements on commercially reasonable terms or at all. Furthermore, the negotiation and completion of potential acquisitions could cause significant diversion of management’s time and resources and potential disruption of our ongoing business. We may also experience difficulties integrating acquired businesses into our existing business and operations. Future acquisitions may also expose us to potential risks, including risks associated with:

 

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the integration of new operations, services and personnel;

 

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unforeseen or hidden liabilities;

 

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the diversion of resources from our existing businesses and technologies;

 

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our inability to generate sufficient revenue to recover costs and expenses of the acquisitions; and

 

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potential loss of, or harm to, relationships with employees or customers, any of which could significantly disrupt our ability to manage our business and materially and adversely affect our business, financial condition and results of operations.

We depend on distributors for all of our revenues and failure to maintain relationships with our distributors or to otherwise expand our distribution network would materially and adversely affect our business.

We sell our products exclusively to pharmaceutical distributors in China and depend on distributors for all of our revenues. We have business relationships with approximately 900 regional distributors in China. In 2004, 2005 and 2006, no single distributor contributed, on an individual basis, 10.0% or more of our total revenues, and sales to our five largest distributors accounted in aggregate for approximately 9.5%, 10.9% and 12.7%, respectively, of our total revenues. In line with industry practices in China, we typically enter into written distribution agreements with our distributors for one-year terms that are generally renewed annually. As our existing distribution agreements expire, we may be unable to renew with our desired distributors on favorable terms or at all. In addition, some of our distributors may sell products that compete with our products. We compete for desired distributors with other pharmaceutical manufacturers, many of which may have higher visibility, greater name recognition and financial resources, and broader product selection than we do. Consequently, maintaining relationships with existing distributors and replacing distributors may be difficult and time-consuming. Any disruption of our distribution network, including our failure to renew our existing distribution agreements with our desired distributors, could negatively affect our ability to effectively sell our products and would materially and adversely affect our business, financial condition and results of operations.

We may not be able to effectively manage our employees, distribution network and third-party marketing firms, and our reputation, business, prospects and brand may be materially and adversely affected by actions taken by our distributors.

We have limited ability to manage the activities of our distributors and third-party marketing firms that we contract to promote our products and brand name, both of which are independent from us. Our distributors and third-party marketing firms could take one or more of the following actions, any of which could have a material adverse effect on our business, prospects and brand:

 

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sell our products outside their designated territory, possibly in violation of the exclusive distribution rights of other distributors;

 

  Ÿ  

fail to adequately promote our products; or

 

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violate the anti-corruption laws of China, the United States or other countries.

In addition, although our company policies prohibit our employees from making improper payments to hospitals or otherwise engaging in improper activities to influence the procurement

 

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decisions of hospitals, we may not be able to effectively manage our employees, as the compensation of our sales and marketing personnel is partially linked to their sales performance. As a result, we cannot assure you that our employees will not violate the anti-corruption laws of China, the United States and other countries. Such violations could have a material adverse effect on our reputation, business, prospects and brand.

Failure to adequately manage our employees, distribution network or third-party marketing firms, or their non-compliance with employment, distribution or marketing agreements could harm our corporate image among end users of our products and disrupt our sales, resulting in a failure to meet our sales goals. Furthermore, we could be liable for actions taken by our employees, distributors or third-party marketing firms, including any violations of applicable law in connection with the marketing or sale of our products, including China’s anti-corruption laws and the Foreign Corrupt Practices Act of the United States, or the FCPA. In particular, if our employees, distributors or third-party marketing firms make any payments that are forbidden under the FCPA, we could be subject to civil and criminal penalties imposed by the U.S. government.

Recently, the PRC government has increased its anti-corruption measures. In the pharmaceutical industry, corrupt practices include, among others, acceptance of kickbacks, bribes or other illegal gains or benefits by the hospitals and medical practitioners from pharmaceutical manufacturers and distributors in connection with the prescription of certain pharmaceuticals. Our employees, affiliates, distributors or third-party marketing firms may violate these laws or otherwise engage in illegal practices with respect to their sales or marking of our products or other activities involving our products. If our employees, affiliates, distributors or third-party marketing firms violate these laws, we could be required to pay damages or fines, which could materially and adversely affect our financial condition and results of operations. In addition, PRC laws regarding what types of payments to promote or sell our products are impermissible are not always clear. As a result, we, our employees, affiliates, our distributors or third-party marketing firms could make certain payments in connection with the promotion or sale of our products or other activities involving our products which at the time are considered by us or them to be legal but are later deemed impermissible by the PRC government. Furthermore, our brand and reputation, our sales activities or the price of our ADSs could be adversely affected if we become the target of any negative publicity as a result of actions taken by our employees, affiliates, distributors or third-party marketing firms.

In addition, government-sponsored anti-corruption campaigns from time to time could have a chilling effect on our marketing efforts to new hospital customers. Our sales representatives may rely on hospital visits to better educate physicians as to our products and to promote our brand awareness. Recently, there were occurrences in which certain hospitals denied access to sales representatives from pharmaceutical companies because the hospitals wanted to avoid the perception of corruption. If this attitude becomes widespread among our potential customers, our ability to promote our products may be adversely affected.

There is no assurance that our existing products will continue to be included or new products developed by us will be included in the Medical Insurance Catalogs.

Eligible participants in the national basic medical insurance program in China, which consists of mostly urban residents, are entitled to reimbursement from the social medical insurance fund for up to the entire cost of medicines that are included in the Medical Insurance Catalogs. See “Regulation of Our Industry—Reimbursement Under the National Medical Insurance Program.” As of March 20, 2007, 21 of our 38 products were included in the national Medical Insurance Catalog and 11 were included in the provincial Medical Insurance Catalog of various provinces, municipalities and autonomous regions. In particular, four of our top five products, including amoxicillin, which we market and sell under the

 

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brand name Zailin; amoxicillin with clavulanate potassium, which we market and sell under the brand name Anqi; diclofenac sodium, which we market and sell under the brand name Yingtaiqing; and smectite powder, which we market and sell under the brand name Biqi, are currently included in the national Medical Insurance Catalog. In addition, edaravone injection, which we market and sell under the brand name Bicun, is currently included in the provincial Medical Insurance Catalog of 22 out of 31 provinces, municipalities and autonomous regions. The inclusion of a medicine in the Medical Insurance Catalogs can substantially improve the sales of the medicine. The Ministry of Labor and Social Security in China, or the MLSS, together with other government authorities from time to time selects medicines to be included in the Medical Insurance Catalogs based on factors including treatment requirements, frequency of use, effectiveness and price. The MLSS also occasionally removes medicines from such catalog. There can be no assurance that our existing products will continue to be included in the Medical Insurance Catalogs. The removal or exclusion of our products from the Medical Insurance Catalogs may adversely affect our sales. In addition, there is significant uncertainty related to the coverage and reimbursement of newly approved pharmaceutical products. The commercial success of our potential products is substantially dependent on whether reimbursement is available for the ordering of our potential products by hospitals for use by their patients. Our failure to obtain inclusion of our potential products to the Medical Insurance Catalogs may adversely affect the future sales of those products.

We have limited insurance coverage and may incur losses resulting from product liability claims or business interruptions.

The nature of our business exposes us to the risk of product liability claims that is inherent in the research and development, manufacturing and marketing of pharmaceutical products. Using product candidates in clinical trials also exposes us to product liability claims. These risks are greater for our products that receive regulatory approval for commercial sale. Even if a product were approved for commercial use by an appropriate governmental agency, there can be no assurance that users will not claim effects other than those intended resulted from the use of our products. While to date no material claim for personal injury resulting from allegedly defective products has been brought against us, a substantial claim or a substantial number of claims, if successful, could have a material adverse impact on our business, financial condition and results of operations. Such lawsuits may divert the attention of our management from our business strategies and may be costly to defend. In addition, product liability insurance for pharmaceutical products are not available in China. In the event of allegations that any of our products are harmful, we may experience reduced consumer demand for our products or our products may be recalled from the market. We may also be forced to defend lawsuits and, if unsuccessful, to pay a substantial amount in damages. In addition, business interruption insurance available in China offers limited coverage compared to that offered in many other countries. We do not have any business interruption insurance. Any business disruption or natural disaster could result in substantial costs and diversion of resources.

Our revenue depends and will likely continue to depend on a limited number of product lines.

We derive a substantial portion of our revenue from the sales of our top five products, Bicun, Zailin, Anqi, Yingtaiqing and Biqi. Sales of these products accounted in aggregate for 82.6% of our product revenues in 2006. We expect sales of these limited product lines, as well as sales of our innovative pharmaceutical Endu, to comprise a substantial portion of our revenues in the future. Accordingly, any factors adversely affecting the sales of any of these products will have a material adverse effect on our business, financial condition and results of operations.

 

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Our limited operating history may not serve as an adequate basis to judge our future prospects and results of operations.

We commenced operations in March 1995 and operated our business mainly as a distributor of pharmaceutical products. Since then, we have gradually built up our research, development and manufacturing capabilities and have become an integrated pharmaceutical company that develops, manufactures and sells pharmaceutical products. Therefore we have a limited operating history under our current business model upon which you can evaluate the viability and sustainability of our business. Accordingly, you should consider our future prospects in light of the risks and uncertainties experienced by other China-based early stage companies. Some of these risks and uncertainties relate to our ability to:

 

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retain and acquire customers;

 

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diversify our revenue sources by successfully developing and selling new products;

 

  Ÿ  

effectively manage our business as it expands;

 

  Ÿ  

respond to changes in our regulatory environment;

 

  Ÿ  

manage risks associated with intellectual property rights;

 

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maintain effective control of our costs and expenses;

 

  Ÿ  

raise sufficient capital to sustain and expand our business; and

 

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attract, retain and motivate qualified personnel.

If we are unsuccessful in addressing any of these risks and uncertainties, our business, financial condition, results of operations and future growth would be adversely affected.

We may not be able to manage our expansion of operations effectively.

We commenced business operations in March 1995, changed our business model in 2001, and have grown rapidly. We anticipate significant continued expansion of our business to address growth in demand for our products, as well as to capture new market opportunities. To manage the potential growth of our operations, we will be required to improve our operational and financial systems, procedures and controls, increase manufacturing capacity and output, and expand, train and manage our growing employee base. Furthermore, we need to maintain and expand our relationships with our customers, suppliers and other third parties. We cannot assure you that our current and planned operations, personnel, systems, internal procedures and controls will be adequate to support our future growth. In addition, the success of our growth strategy depends on a number of internal and external factors, such as the expected growth of the pharmaceutical market in China and the competition from other pharmaceutical companies. If we are unable to manage our growth effectively, we may not be able to take advantage of market opportunities, execute our business strategies or respond to competitive pressures.

We have no control over the development and sale of Endu outside of the PRC. Our brand and reputation may be adversely affected if the development and sale of Endu outside of the PRC violate the intellectual property rights of any third parties.

Hong Kong Medgenn, an affiliate company in which we owned indirectly an effective 32.0% equity interest as of March 20, 2007, has the ability to engage in the development and sale of Endu in any jurisdiction outside of the PRC, including the United States, until February 10, 2015. Approximately 6.3% and approximately 1.7% of Hong Kong Medgenn was owned by Dr. Yongzhang Luo and Dr. Bin Zhou, two of the scientists who have developed Endu, through their respective minority interest ownership in

 

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Yantai Medgenn. The other 60.0% of Hong Kong Medgenn was owned by Bestspeed Investments Limited, or Bestspeed, a British Virgin Islands company. Hong Kong Medgenn is controlled by its board of directors, which has five members, including Dr. Yongzhang Luo, Mr. Willi Chu and Mr. Linghai Zhu, all of whom were appointed by Bestspeed, and Mr. Jinsheng Ren and Mr. Xiaojin Yin, both of whom were appointed by Yantai Medgenn and are also our executive officers. Bestspeed was a shareholder of Hong Kong Medgenn prior to our acquisition of an 80.0% equity interest in Yantai Medgenn and we are unable to ascertain the identities of the natural persons who control Bestspeed. Although it has no paid-in capital and has not commenced any operations to date, and we have not yet obtained any regulatory approval outside of the PRC to sell Endu, Hong Kong Medgenn holds the rights to apply for patents and may grant its rights with respect to Endu in these jurisdictions to independent third parties. A cooperation agreement entered into on February 10, 2005 between Bestspeed and Yantai Medgenn provides Bestspeed with daily operating control over Hong Kong Medgenn’s business, including the development and sale of Endu in any jurisdiction outside of the PRC until February 10, 2015. If Hong Kong Medgenn violates the intellectual property rights of any third parties or otherwise suffers economic or other losses, our brand, reputation, business and results of operations could be adversely affected. In addition, the agreements with Hong Kong Medgenn will prohibit us from engaging in the development and sale of Endu outside of the PRC prior to February 10, 2015, which might hinder our ability to grow our business outside of the PRC.

Our business depends substantially on the continuing efforts of our executive officers, research personnel and other key personnel, and our business may be severely disrupted if we lose their services.

We depend on key members of our management team, research personnel and other key personnel. In particular, we depend on the services of Mr. Jinsheng Ren, our founder, the chairman of our board of directors and our chief executive officer, Mr. Xiaojin Yin, our vice president of research and development, and Mr. Yat Ming Chu, our vice president of sales and marketing. The loss of key employees could delay the advancement of our research and development activities. The implementation of our business strategy and our future success will depend in large part on our continued ability to attract and retain highly qualified scientific, technical and management personnel. We face competition for personnel from other pharmaceutical companies, universities, public and private research institutions and other organizations. The process of hiring suitably qualified personnel is often lengthy. If our recruitment and retention efforts are unsuccessful in the future, it may be more difficult for us to execute our business strategy.

We do not maintain key employee insurance. If one or more of our executive officers, research personnel and other key personnel are unable or unwilling to continue in their present positions, we may not be able to replace them readily, if at all. Therefore, our business may be severely disrupted, and we may incur additional expenses to recruit and retain new officers. In addition, if any of our executive officers or key research personnel joins a competitor or forms a competing company, we may lose some of our customers. Each of our executive officers, key research personnel and marketing managers has entered into a confidentiality and non-competition agreement with us. However, if any disputes arise between our executive officers, key research personnel and marketing managers and us, we cannot assure you, in light of uncertainties associated with the PRC legal system, the extent to which any of these agreements could be enforced in China, where some of our executive officers reside and hold some of their assets. See “—Risks Related to Doing Business in China—Uncertainties with respect to the PRC legal system could have a material adverse effect on us.”

 

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Delays in production due to regulatory restrictions or other factors could have a material adverse impact on our business.

We manufacture substantially all of our products in our own manufacturing facilities. The manufacture of pharmaceutical products requires precise and reliable controls and regulatory authorities in China have imposed significant compliance obligations to regulate the manufacturing of pharmaceutical products. As a result, we may face delays in production due to regulatory restrictions or other factors. In addition, three of our generic pharmaceuticals, the Yingtaiqing-branded diclofenac sodium, the Faneng-branded alfacalcidol soft capsules and the Yineng-branded generic lentinan injection, are all manufactured by independent third party manufacturers. Our contract manufacturers may not be able to manufacture our products without interruption, may not comply with their obligations under our various supply arrangements, and we may not have adequate remedies for any breach. Failure by our own manufacturing facility or any third party product supplier to comply with regulatory requirements could adversely affect our ability to provide products. All facilities and manufacturing techniques used for the manufacture of pharmaceutical products must be operated in conformity with Good Manufacturing Practices, or GMPs. In complying with GMP requirements, we and our product suppliers must continually spend time, money and effort in production, record-keeping and quality assurance and control to ensure that the product meets applicable specifications and other requirements for product safety, efficacy and quality. Manufacturing facilities are subject to periodic unannounced inspections by the SFDA and other regulatory authorities. In addition, adverse experiences with the use of products must be reported to the SFDA and could result in the imposition of market restrictions through labeling changes or in product removal.

Suppliers of certain active and inactive pharmaceutical ingredients and certain packaging materials used in our products are required to obtain SFDA approval before they may supply us with such materials. The development and regulatory approval of our products are dependent upon our ability to procure these ingredients, packaging materials and finished products from SFDA-approved sources. SFDA approval of a new supplier would be required if, for example, an existing supplier breached its obligations to us, active ingredients, packaging materials or finished products were no longer available from the initially approved supplier or if a supplier had its approval from the SFDA withdrawn. The qualification of a new product supplier could potentially delay the manufacture of the product involved. Furthermore, we may not be able to obtain active ingredients, packaging materials or finished products from a new supplier on terms that are at least as favorable to us as those agreed with the initially approved supplier or at reasonable prices.

A delay in supplying, or failure to supply, products by any product supplier could result in our inability to meet the demand for our products and adversely affect our revenues, financial condition, results of operations and cash flows.

Our operating results may fluctuate considerably on a quarterly basis. These fluctuations could have an adverse effect on the price of our shares and ADSs.

Our results of operations may fluctuate significantly on a quarterly basis as a result of a number of factors, many of which are beyond our control. Although many companies may encounter this problem, it is particularly relevant to us because of our relatively small size, our limited operating history, our reliance on limited number of products and the dynamics of the Chinese pharmaceutical industry in which we operate. Factors that could cause our results of operations to fluctuate include, among others:

 

  Ÿ  

the seasonal fluctuations in demand for our products, especially our antibiotics, such as Zailin and Anqi;

 

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timing of research and development expenses;

 

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regulatory events;

 

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  Ÿ  

new product introductions by us or our competitors;

 

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variations in the demand for products we may introduce;

 

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litigation involving patents, licenses or other intellectual property; and

 

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product liability lawsuits.

Any of the foregoing factors could cause us to fail to meet the expectations of securities analysts or investors, which could cause the trading price of our shares and ADSs to decline.

Our future liquidity needs are uncertain and we may need to raise additional funds in the future.

As of December 31, 2006, we had RMB333.0 million ($42.7 million) in outstanding short-term bank loans and borrowings and RMB106.0 million ($13.6 million) in cash, and our working capital deficit amounted to RMB156.7 million ($20.1 million). Based on our current operating plans, we expect our existing resources, together with our net proceeds from this offering, to be sufficient to fund our planned operations, including strengthening our research and development capabilities, acquiring product candidates, products or businesses, expanding our production capacity and expanding our sales and marketing efforts, for at least the next 24 months. We may, however, need to raise additional funds before that time if our expenditures exceed our current expectations. This could occur for a number of reasons, including:

  Ÿ  

we determine to devote significant amount of financial resources to the research and development of projects that we believe to have significant commercialization potential;

 

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we determine to acquire or license rights to additional product candidates or new technologies;

 

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some or all of our product candidates fail in clinical trials or pre-clinical studies or prove to be not as commercially promising as we expect and we are forced to develop or acquire additional product candidates;

 

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our product candidates require more extensive clinical or pre-clinical testing or clinical trials of these product candidates take longer to complete than we currently expect; or

 

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we determine or are required to conduct more high-throughput screening than expected against current or additional disease targets to develop additional product candidates.

Our ability to raise additional funds in the future is subject to a variety of uncertainties, including:

 

  Ÿ  

our future financial condition, results of operations and cash flows;

 

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general market conditions for capital-raising activities by pharmaceutical companies; and

 

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economic, political and other conditions in China and elsewhere.

We cannot assure you that our revenues will be sufficient to meet our operational needs and capital requirements. If we need to obtain external financing, we cannot assure you that financing will be available in amounts or on terms acceptable to us, if at all. Our future liquidity needs and other business reasons could require us to sell additional equity or debt securities or obtain a credit facility. The sale of additional equity or equity-linked securities could result in additional dilution to our shareholders. The incurrence of additional indebtedness would result in increased debt service obligations and could result in operating and financing covenants that would restrict our operations.

 

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A significant amount of intangible assets and goodwill are recorded on our balance sheet. Future impairment of our intangible assets or goodwill could have a material adverse impact on our financial condition and results of operations.

As of December 31, 2006, our net intangible assets amounted to RMB163.1 million ($20.9 million), representing 15.8% of our total assets, and goodwill amounted to RMB100.6 million ($12.9 million), representing 9.7% of our total assets. Our intangible assets primarily consisted of developed technology that we acquired in connection with our acquisition of an 80.0% equity interest in Yantai Medgenn in September 2006. Specifically, developed technology represents the right to use, manufacture, market and sell Endu as well as the Endu-related invention patents in the PRC and the United States. Our developed technology amounted to RMB144.4 million ($18.5 million), representing 14.0% of our total assets as of December 31, 2006. We estimated the fair value of the developed technology of Endu using the present value of Endu’s projected cash flows based on assumptions with respect to the growth rate of our revenues from sales of Endu, the earnings before interest and tax margin derived from sales of Endu, the discount rate selected to measure the risks inherent in future cash flows from Endu, and our assessment of Endu’s life cycle. We also took into consideration the competitive trends that may affect Endu’s sales, including consideration of any technical, legal, regulatory, and economic barriers to entry. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies—Long-Lived Assets and Goodwill.” We determined the useful life of the developed technology of Endu by considering the remaining protection period of Endu’s patent in China and the expected competitive trend in the PRC market. Goodwill was generated primarily from our acquisition of Yantai Medgenn as the cost of the acquisition exceeded the fair value of the net tangible and identifiable intangible assets acquired. While no impairment write-downs or change in useful life have been necessary to date, future events such as market acceptance of Endu, introduction of superior pharmaceuticals by our competitors, regulatory actions, safety concerns as to our pharmaceuticals, and challenges to and infringement of our intellectual property rights, could have a material impact on our key assumptions in determining the fair value of the developed technology of Endu. This in turn could result in write-down of our intangible assets or goodwill, or change in the useful lives of our intangible assets. Future write-downs of our intangible assets or goodwill, or change in useful lives of our intangible assets, could decrease our net income, which would have a material adverse impact on our financial condition and results of operations.

Our existing shareholders have substantial influence over our company and their interests may not be aligned with the interests of our other shareholders.

As of the date of this prospectus, we had two shareholders, New Good Management Limited and Assure Ahead Investments Limited. New Good Management Limited is a company beneficially owned by 15 individuals, including certain of our senior management, and controlled by Mr. Jinsheng Ren, our founder, chief executive officer and chairman of our board of directors. Assure Ahead Investments Limited is an investment vehicle owned and controlled by a group of financial investors. As of the date of this prospectus, New Good Management Limited owned 69.0% of our outstanding share capital and will own approximately             % of our outstanding share capital upon completion of this offering, and our other shareholder, Assure Ahead Investments Limited, owned 31.0% of our outstanding share capital and will own approximately             % of our outstanding share capital upon completion of this offering. As such, they have substantial influence over our business, including decisions regarding mergers, consolidations and the sale of all or substantially all of our assets, election of directors and other significant corporate actions. This concentration of ownership may discourage, delay or prevent a change in control of our company, which could deprive our shareholders of an opportunity to receive a premium for their shares as part of a sale of our company and might reduce the price of our ADSs.

 

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Our production activities involve the controlled use of potentially harmful biological materials as well as hazardous materials and chemicals.

Our production activities involve the controlled use of potentially harmful biological materials as well as hazardous materials and chemicals. We cannot completely eliminate the risk of accidental contamination or injury from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be held liable for damages that result, which could exceed our resources. We are subject to national, provincial and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. We believe we are currently in compliance with these laws and regulations. However, any failure by us to control the use, storage, handling and disposal of these hazardous materials and chemicals could subject us to potentially significant monetary damages and fines or suspensions of our business operations. In addition, we do not currently carry any insurance for potential liabilities relating to the release of hazardous materials as such insurance is not currently available in China.

If we grant additional employee share options, restricted shares or other share-based compensation in the future, our net income could be adversely affected.

We adopted a share incentive plan on November 13, 2006. We issued 10.0 million and 1,045,000 share options under our share incentive plan on November 15, 2006 and March 22, 2007, respectively. We are required to account for share-based compensation in accordance with Financial Accounting Standards Board Statement No. 123(R), Share-Based Payment, which requires a company to recognize, as an expense, the fair value of share options and other share-based compensation to employees based on the fair value of equity awards on the date of the grant, with the compensation expense recognized over the period in which the recipient is required to provide service in exchange for the equity award. If we grant additional options, restricted shares and other equity incentives in the future, we could incur significant compensation charges and our net income could be adversely affected.

We may be unable to establish and maintain an effective system of internal control over financial reporting, and as a result we may be unable to accurately report our financial results or prevent fraud.

Upon completion of this offering, we will become a public company in the United States that is, or will be subject to, the Sarbanes-Oxley Act. Section 404 of the Sarbanes-Oxley Act, or Section 404, will require that we include a report from management on our internal control over financial reporting in our annual report on Form 20-F beginning with our annual report for the fiscal year ending December 31, 2008. In addition, our independent registered public accounting firm must attest to and report on management’s assessment of the effectiveness of our internal control over financial reporting. Our management may conclude that our internal controls are not effective. Moreover, even if our management concludes that our internal control over financial reporting is effective, our independent registered public accounting firm may disagree and may decline to attest to our management’s assessment or may issue an adverse opinion. Any of these possible outcomes could result in an adverse reaction in the financial marketplace due to a loss of investor confidence in the reliability of our reporting processes, which could adversely affect the trading price of our ADSs.

Our reporting obligations as a public company will place a significant strain on our management, operational and financial resources and systems for the foreseeable future. We may identify control deficiencies as a result of the assessment process we will undertake in compliance with Section 404 including but not limited to internal audit resources and formalized and documented closing and reporting processes. We plan to remediate control deficiencies identified in time to meet the deadline imposed by the requirements of Section 404 but we may be unable to do so. Our failure to establish and maintain effective internal control over financial reporting could result in the loss of investor confidence in the reliability of our financial reporting processes, which in turn could harm our business and negatively impact the trading price of our ADSs.

 

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Counterfeit pharmaceuticals in China could negatively impact our revenues, brand reputation, business and results of operations.

Our products are also subject to competition from counterfeit pharmaceuticals, which are pharmaceuticals manufactured without proper licenses or approvals and are fraudulently mislabeled with respect to their content and/or manufacturer. Counterfeiters may illegally manufacture and market pharmaceuticals under our brand name or that of our competitors. Counterfeit pharmaceuticals are generally sold at lower prices than the authentic products due to their low production costs, and in some cases are very similar in appearance to the authentic products. Counterfeit pharmaceuticals may or may not have the same chemical content as their authentic counterparts. If counterfeit pharmaceuticals illegally sold under our brand name results in adverse side effects to consumers, we may be associated with any negative publicity resulting from such incidents. In addition, consumers may buy counterfeit pharmaceuticals that are in direct competition with our pharmaceuticals, which could have an adverse impact on our revenues, business and results of operations. Although the PRC government has recently been increasingly active in policing counterfeit pharmaceuticals, there is not yet an effective counterfeit pharmaceutical regulation control and enforcement system in China. The proliferation of counterfeit pharmaceuticals has grown in recent years and may continue to grow in the future. Any such increase in the sales and production of counterfeit pharmaceuticals in China, or the technological capabilities of the counterfeiters, could negatively impact our revenues, brand reputation, business and results of operations.

Inappropriate use of our trade names by other entities could negatively affect our business.

Our trade name Simcere is also used by companies which are partially owned and controlled by certain shareholders of New Good Management Limited. If any such entity or any company that is unrelated to us uses the trade name Simcere in ways that negatively affect such trade names, our reputation could suffer harm, which in turn could have a material adverse effect on our financial condition and results of operations.

We may be classified as a passive foreign investment company, which could result in adverse United States federal income tax consequences to U.S. holders.

We do not expect to be considered a “passive foreign investment company,” or PFIC, for United States federal income tax purposes for our taxable year ending December 31, 2007. However, we must make a separate determination each year as to whether we are a PFIC and we cannot assure you that we will not be a PFIC for our taxable year ending December 31, 2007 or any future taxable year. A non-U.S. corporation will be considered a PFIC for any taxable year if either (1) at least 75% of its gross income is passive income or (2) at least 50.0% of the value of its assets (based on an average of the quarterly values of the assets during a taxable year) is attributable to assets that produce or are held for the production of passive income. The market value of our assets may be determined in large part by the market price of our ADSs and ordinary shares, which is likely to fluctuate after this offering. In addition, the composition of our income and assets will be affected by how, and how quickly, we spend the cash we raise in this offering. If we are treated as a PFIC for any taxable year during which U.S. holders hold ADSs or ordinary shares, certain adverse United States federal income tax consequences could apply to U.S. holders. See “Taxation—United States Federal Income Taxation—Passive Foreign Investment Company.”

If a poll is not demanded at our shareholder meetings, voting will be by show of hands and shares will not be proportionately represented. Shareholder resolutions may be passed without the presence of the majority of our shareholders in person or by proxy.

Voting at any of our shareholder meetings is by show of hands unless a poll is demanded. A poll may be demanded by the chairman of the meeting or by any shareholder present in person or by

 

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proxy. If a poll is demanded, each shareholder present in person or by proxy will have one vote for each ordinary share registered in his name. If a poll is not demanded, voting will be by show of hands and each shareholder present in person or by proxy will have one vote regardless of the number of shares registered in his name. In the absence of a poll, shares will therefore not be proportionately represented. In addition, the quorum required for our shareholder meetings consists of shareholders who hold at least one-third of our ordinary shares being present at a meeting in person or by proxy. Therefore, subject to the requisite majorities, shareholder resolutions may be passed at our shareholder meetings without the presence of the majority of our shareholders in person or by proxy.

Risks Related to Our Industry

We face intense competition that may prevent us from maintaining or increasing market share for our existing products and gaining market acceptance for our future products. Our competitors may develop or commercialize products before us or more successfully than us.

The pharmaceutical market in China is intensely competitive, rapidly evolving and highly fragmented. Our competitors may develop products that are superior to ours or may be more effective in marketing products that are competitive with ours. We face competition from other pharmaceutical companies, including multinational companies as well as manufacturers of traditional Chinese medicines with similar curative effects that can be used as substitutes for certain of our products. Our major products include Bicun, Zailin, Anqi, Yingtaiqing, Biqi and Endu. Bicun competes with another edaravone product Yidasheng, which is manufactured by Jilin Boda Pharmaceutical Co., Ltd. in China; Zailin competes with other generic amoxicillin antibiotics manufactured by over 100 manufacturers in China, and our most significant competitor is Zhuhai United Laboratories Pharmaceutical Co., Ltd., which had a market share of 20.3% and 17.8% of all amoxicillin granules sold in hospitals and retail outlets in China in 2005, respectively, based on information provided by the Southern Pharmaceutical Economic Research Institute; Anqi competes with other generic amoxicillin with clavulanate potassium antibiotics manufactured by over 60 other manufacturers in China, and our most significant competitors are North China Pharmaceutical Group Corporation, which had a market share of 19.3% of all amoxicillin with clavulanate potassium sold in hospitals in China in 2005, and Shenyang Shide Pharmaceutical Co., Ltd., which had a market share of 37.7% of all amoxicillin with clavulanate potassium sold in retail outlets in China in 2005, based on information provided by the Southern Pharmaceutical Economic Research Institute; Yingtaiqing competes with other generic diclofenac sodium manufactured by at least 13 multinational or China-based pharmaceutical companies, and our most significant competitor is Beijing Novartis Pharma Ltd., which had a market share of 26.3% and 36.3% of all diclofenac sodium pharmaceuticals sold in hospitals and retail outlets in China in 2005, respectively, according to research conducted by IMS Health; and Biqi competes with smectite powder manufactured by two other manufacturers in China and other types of diarrhea medicines available in the China market. Our competitors Beaufour-Ipsen (Tianjin) Pharmaceutical Co., Ltd. and Zhejiang Hailisheng Group Co., Ltd. had a market share of 73.2% and 15.6%, respectively, of all smectite powder sold in hospitals in China, according to research conducted by IMS Health. Endu, our innovative anti-cancer pharmaceutical and the first recombinant human endostatin injection approved for sale in China, currently does not have any directly competitive product with the same chemical composition. However, Endu indirectly competes with other types of cancer treatments currently available in China. See “Business—Competition.”

Many of our existing and potential competitors may have greater financial, technical, manufacturing and other resources than we do. For example, certain of our competitors, such as North China Pharmaceutical Group, that are listed on the stock exchanges in China have better access to capital than we do. In addition, competitors such as Beijing Novartis Pharma Ltd. and Beaufour-Ipsen (Tianjin) Pharmaceutical Co., Ltd., which were established by multinational pharmaceutical companies, have more extensive research and development and technical capabilities than we do. Furthermore, China’s industry reforms aimed to meet the WTO requirements may foster increased competition from multinational pharmaceutical companies. Such competitors may also have greater brand name

 

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recognition, more established distribution networks, larger customer bases or more extensive knowledge of our target markets. Our competitors’ greater size in some cases provides them with a competitive advantage with respect to manufacturing costs because of their economies of scale and their ability to purchase raw materials at lower prices. As a result, they may be able to devote greater resources to the research, development, promotion and sale of their products or respond more quickly to evolving industry standards and changes in market conditions than we can. In addition, certain of our competitors may adopt low-margin sales strategies and compete against us based on lower prices. Our failure to adapt to changing market conditions and to compete successfully with existing or new competitors may materially and adversely affect our financial condition and results of operations.

In addition, to increase sales, certain manufacturers or distributors of pharmaceuticals may engage in questionable practices in order to influence procurement decisions of our customers. As a result, as competition intensifies in the pharmaceutical industry in China, we may lose sales, customers or contracts to competitors that engage in these practices.

The retail prices of certain of our products are subject to control, including periodic downward adjustment, by PRC government authorities.

Certain of our pharmaceutical products, primarily those included in the national and provincial Medical Insurance Catalogs, are subject to price controls in the form of fixed retail prices or retail price ceilings. See “Regulation of Our Industry—Price Controls.” In addition, the maximum retail prices of products that are included in the Medical Insurance Catalogs are also subject to periodic downward adjustments as the PRC government authorities aim to make pharmaceuticals more affordable to the general public. However, PRC Government authorities impose no control over the prices pharmaceutical manufacturers sell their products to their distributors. Since May 1998, the relevant PRC government authorities have ordered price reductions of various pharmaceuticals 22 times. The latest price reductions occurred in January 2007 and March 2007 and affected 354 and 278 different pharmaceuticals, respectively. The retail price ceilings of our major products Anqi and Zailin, both of which are included in the national Medical Insurance Catalog, were adjusted downward in June 2004, and the retail price ceilings of our Faneng branded alfacalcidol soft capsules and Simcere Kechuanning branded herbal cough medicine were adjusted downward in January and March 2007, respectively. As of March 20, 2007, we have not adjusted our selling prices of Faneng and Simcere Kechuanning downward because their actual retail prices before the price reductions were close to their retail price ceilings after the price reductions. We do not plan to make adjustments to our prices of Faneng and Simcere Kechuanning in the near future. However, in the long term, the prices at which pharmaceutical manufacturers in China sell their products to distributors, including the prices of our products, will be affected by the relevant fixed retail prices or retail price ceilings. Government price controls, especially downward price adjustments, may have a material adverse effect on our revenues and profitability.

Pharmaceutical companies in China require a number of permits and licenses in order to carry on their business.

All pharmaceutical manufacturing and distribution companies in China are required to obtain certain permits and licenses from various PRC governmental authorities, including, in the case of manufacturing companies, a pharmaceutical manufacturing permit and, in the case of distribution companies, a pharmaceutical distribution permit. See “Regulation of Our Industry.”

We have obtained permits and licenses and GMP certifications required for the manufacture of our pharmaceutical products. In addition, we have obtained permits, licenses and Good Supply Practice, or GSP, certifications for the distribution of our products. Each of these permits and licenses held by us is valid for five years and subject to periodic renewal and/or reassessment by the relevant PRC government authorities and the standards of compliance required in relation thereto may from time to time be subject to changes. For example, the current pharmaceutical manufacturing permit for each of Hainan Simcere, Nanjing Simcere and Yantai Medgenn will expire on December 31, 2010. The ten GMP certificates for our three manufacturing facilities will expire between August 2007 and August 2011, and the two GSP certificates held by two of our distribution subsidiaries will expire in June 2008

 

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and December 2009, respectively. See “Regulation of Our Industry.” We intend to apply for the renewal of such permits and licenses when required by applicable laws and regulations. Any failure by us to obtain such renewals may have a material adverse effect on the operation of our business, and prevent us from continuing to carry on our business. Furthermore, any changes in compliance standards, or any new laws or regulations may prohibit or render it more restrictive for us to conduct our business or may increase our compliance costs, which may adversely affect our operations or profitability.

Risks Related to Doing Business in China

Uncertainties with respect to the PRC legal system could have a material adverse effect on us.

The PRC legal system is a civil law system based on written statutes. Unlike in the common law system, prior court decisions may be cited for reference but have limited precedential value. Since 1979, PRC legislation and regulations have significantly enhanced the protections afforded to various forms of foreign investments in China. We conduct all of our business through our subsidiaries established in China. These subsidiaries are generally subject to laws and regulations applicable to foreign investment in China and, in particular, laws applicable to wholly foreign-owned enterprises. However, since these laws and regulations are relatively new and the PRC legal system continues to rapidly evolve, the interpretations of many laws, regulations and rules are not always uniform and enforcement of these laws, regulations and rules involve uncertainties, which may limit legal protections available to us. For example, we may have to resort to administrative and court proceedings to enforce the legal protection that we enjoy either by law or contract. However, since PRC administrative and court authorities have significant discretion in interpreting and implementing statutory and contractual terms, it may be more difficult to evaluate the outcome of administrative and court proceedings and the level of legal protection we enjoy than in more developed legal systems. These uncertainties may impede our ability to enforce the contracts we have entered into with our business partners, customers and suppliers. In addition, such uncertainties, including the inability to enforce our contracts, could materially and adversely affect our business and operations. Furthermore, intellectual property rights and confidentiality protections in China may not be as effective as in the United States or other countries. Accordingly, we cannot predict the effect of future developments in the PRC legal system, particularly with regard to the Chinese pharmaceutical industry, including the promulgation of new laws, changes to existing laws or the interpretation or enforcement thereof, or the preemption of local regulations by national laws. These uncertainties could limit the legal protections available to us and other foreign investors, including you. In addition, any litigation in China may be protracted and result in substantial costs and diversion of our resources and management attention.

Adverse changes in political and economic policies of the PRC government could have a material adverse effect on the overall economic growth of China, which could reduce the demand for our products and materially and adversely affect our competitive position.

All of our business operations are conducted in China and all of our sales are made in China. Accordingly, our business, financial condition, results of operations and prospects are affected significantly by economic, political and legal developments in China. The Chinese economy differs from the economies of most developed countries in many respects, including:

 

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the degree of government involvement;

 

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the level of development;

 

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the growth rate;

 

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the control of foreign exchange;

 

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access to financing; and

 

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the allocation of resources.

While the Chinese economy has grown significantly in the past 25 years, the growth has been uneven, both geographically and among various sectors of the economy. The PRC government has implemented various measures to encourage economic growth and guide the allocation of resources.

 

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Some of these measures benefit the overall Chinese economy, but may also have a negative effect on us. For example, our financial condition and results of operations may be adversely affected by government control over capital investments or changes in tax regulations that are applicable to us.

The Chinese economy has been transitioning from a planned economy to a more market-oriented economy. Although in recent years the PRC government has implemented measures emphasizing the utilization of market forces for economic reform, the reduction of state ownership of productive assets and the establishment of sound corporate governance in business enterprises, a substantial portion of the productive assets in China is still owned by the PRC government. The continued control of these assets and other aspects of the national economy by the PRC government could materially and adversely affect our business. The PRC government also exercises significant control over China’s economic growth through the allocation of resources, controlling payment of foreign currency-denominated obligations, setting monetary policy and providing preferential treatment to particular industries or companies. Since late 2003, the PRC government implemented a number of measures, such as raising bank reserves against deposit rates to place additional limitations on the ability of commercial banks to make loans and raise interest rates, in order to decrease the growth rate of specific segments of China’s economy which it believed to be overheating. These actions, as well as future actions and policies of the PRC government, could materially affect our liquidity and access to capital and our ability to operate our business.

We rely on dividends paid by our subsidiaries for our cash needs, and any limitation on the ability of our subsidiaries to make payments to us could have a material adverse effect on our ability to conduct our business.

We conduct all of our business through our subsidiaries established in China. We rely on dividends paid by these subsidiaries for our cash needs, including the funds necessary to pay dividends and other cash distributions to our shareholders, to service any debt we may incur and to pay our operating expenses. The payment of dividends by entities established in China is subject to limitations. Regulations in China currently permit payment of dividends only out of accumulated profits as determined in accordance with accounting standards and regulations in China. Each of our PRC subsidiaries including wholly foreign-owned enterprises, or WFOEs, and domestic companies is also required to set aside at least 10.0% of its after-tax profit based on PRC accounting standards each year to its general reserves or statutory capital reserve fund until the accumulative amount of such reserves reach 50.0% of its respective registered capital. As of December 31, 2006, our restricted reserves amounted to RMB49.9 million ($6.4 million), and our accumulated profits that were unrestricted and were available for distribution amounted to RMB119.0 million ($15.2 million). Our restricted reserves are not distributable as cash dividends. In addition, if any of our PRC subsidiaries incurs debt on its own behalf in the future, the instruments governing the debt may restrict its ability to pay dividends or make other distributions to us.

PRC regulation of loans and direct investment by offshore holding companies to PRC entities may delay or prevent us from using the proceeds of this offering to make loans or additional capital contributions to our PRC operating subsidiaries and affiliated entities, which could materially and adversely affect our liquidity and our ability to fund and expand our business.

In utilizing the proceeds of this offering in the manner described in “Use of Proceeds,” as an offshore holding company of our PRC subsidiaries, we may make loans to our PRC subsidiaries, or we may make additional capital contributions to our PRC subsidiaries. Any loans to our PRC subsidiaries are subject to PRC regulations and approvals. For example, loans by us to our wholly owned

 

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subsidiaries in China, each of which is a foreign-invested enterprise, to finance their activities cannot exceed statutory limits and must be registered with the State Administration of Foreign Exchange in China, or the SAFE, or its local counterpart.

We may also decide to finance our wholly owned subsidiaries by means of capital contributions. These capital contributions must be approved by the Ministry of Commerce in China or its local counterpart. We cannot assure you that we will be able to obtain these government registrations or approvals on a timely basis, if at all, with respect to future loans or capital contributions by us to our subsidiaries or any of their respective subsidiaries. If we fail to receive such registrations or approvals, our ability to use the proceeds of this offering and to capitalize our PRC operations may be negatively affected, which could adversely and materially affect our liquidity and our ability to fund and expand our business.

The approval of the PRC Securities Regulatory Commission, or the CSRC, may be required in connection with this offering under a recently adopted PRC regulation; any requirement to obtain prior CSRC approval could delay this offering and a failure to obtain this approval, if required, could have a material adverse effect on our business, operating results, reputation and trading price of our ADSs, and may also create uncertainties for this offering.

On August 8, 2006, six PRC regulatory agencies, including the CSRC, promulgated a regulation that purport to require an offshore special purpose vehicle, or SPV, formed for listing purposes and controlled directly or indirectly by PRC companies or individuals to obtain the approval of the CSRC prior to the listing and trading of such SPV’s securities on an overseas stock exchange. The application of this new PRC regulation is unclear. On September 21, 2006, the CSRC issued a clarification that sets forth the criteria and process for obtaining any required approval from the CSRC.

Our PRC counsel, Jingtian & Gongcheng, has advised us that:

 

  Ÿ  

the CSRC approval requirement applies to SPVs that acquired equity interests in PRC companies through share exchanges and using cash;

 

  Ÿ  

based on their understanding of the current PRC laws, rules and regulations and the new regulation, unless there are new PRC laws, rules and regulations or clear requirements from the CSRC in any form that require the prior approval of the CSRC for the listing and trading of any SPV’s securities on an overseas stock exchange, the new regulation does not require that we obtain prior CSRC approval for the listing and trading of our ADSs on the New York Stock Exchange, because we completed our reorganization under which the equity interests in our operating subsidiaries were transferred to SGG, an SPV, in March 2006, prior to September 8, 2006, the effective date of the new regulation; and

 

  Ÿ  

subject to the timing and contents of any new laws, rules and regulations or clear requirements from the CSRC in any form relating to the new regulation, the legal advice of Jingtian & Gongcheng summarized above may need to be changed.

However, if the CSRC subsequently determines its prior approval was required, we may face regulatory actions or other sanctions from the CSRC or other PRC regulatory agencies. These regulatory agencies may impose fines and penalties on our operations, limit our operating privileges, delay or restrict the repatriation of the proceeds from this offering into China, or take other actions that could have a material adverse effect on our business, financial condition, results of operations, reputation and prospects, as well as the trading price of our ADSs. The CSRC or other PRC regulatory agencies also may take actions requiring us, or making it advisable for us, to halt this offering before settlement and delivery of the ADSs offered hereby. Consequently, if you engage in market trading or other activities in anticipation of and prior to settlement and delivery, you do so at the risk that settlement and delivery may not occur.

We cannot predict when the CSRC may promulgate additional rules or other guidance, if at all. If implementing rules or guidance is issued prior to the completion of this offering and consequently we

 

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conclude we are required to obtain CSRC approval, this offering will be delayed until we obtain CSRC approval, which may take several months or longer. Furthermore, any delay in the issuance of such implementing rules or guidance may create additional uncertainties with respect to this offering. Moreover, implementing rules or guidance, to the extent issued, may fail to resolve current ambiguities under this new PRC regulation. Uncertainties and/or negative publicity regarding this new PRC regulation could have a material adverse effect on the trading price of our ADSs.

Recent PRC regulations relating to the establishment of offshore special purpose companies by PRC residents may subject our PRC resident shareholders to personal liability, limit our ability to inject capital into our PRC subsidiaries, limit our PRC subsidiaries’ ability to distribute profits to us, or otherwise adversely affect us.

SAFE issued a public notice in October 2005, requiring PRC residents to register with the local SAFE branch before establishing or controlling any company outside of China for the purpose of capital financing with assets or equities of PRC companies, referred to in the notice as an “offshore special purpose company.” PRC residents that are shareholders of offshore special purpose companies established before November 1, 2005 were required to register with the local SAFE branch before March 31, 2006. Our current beneficial owners who are PRC residents have registered with the local SAFE branch as required under the SAFE notice. The failure of these beneficial owners to timely amend their SAFE registrations pursuant to the SAFE notice or the failure of future beneficial owners of our company who are PRC residents to comply with the registration procedures set forth in the SAFE notice may subject such beneficial owners to fines and legal sanctions and may also limit our ability to contribute additional capital into our PRC subsidiaries, limit our PRC subsidiaries’ ability to distribute dividends to our company or otherwise adversely affect our business.

The discontinuation of any preferential tax treatment currently available to us and the increase in the enterprise income tax in the PRC could in each case result in a decrease of our net income and materially and adversely affect our results of operations.

The basic enterprise income tax rate for foreign-invested enterprises in the PRC is currently 33.0% (30.0% state tax and 3.0% local tax). The PRC government has provided various incentives to foreign-invested enterprises and domestic companies operating in a national level economic and technological development zone, including reduced tax rates and other measures. Each of our subsidiaries Hainan Simcere, Qitian Simcere and Yantai Medgenn is registered and operating in a national level economic and technological development zone, and each is entitled to a preferential enterprise income tax rate of 15.0%. In addition, each of Hainan Simcere and Nanjing Simcere was converted from a domestic company to a foreign-invested enterprise in March 2006 and Yantai Medgenn was converted to a foreign-invested enterprise in March 2001. As a foreign-invested enterprise, each of these companies is entitled to a two-year exemption from enterprise income tax for the first two profitable years of operation, and thereafter entitled to a 50.0% relief from enterprise income tax for the succeeding three years. As a result of these preferential tax treatments and other local tax incentives, our effective income tax rates were 31.8%, 23.9% and 3.9% in 2004, 2005 and 2006, respectively. However, we cannot assure you that the current preferential tax treatments and the current level of the enterprise income tax enjoyed by our PRC operating subsidiaries will continue, and any legislative changes to the tax regime could discontinue any preferential tax treatment and increase the enterprise income tax rate applicable to our principal subsidiaries in the PRC.

Specifically, the PRC Enterprise Income Tax Law, or the EIT Law, was enacted in March 16, 2007. Under the EIT Law, effective on January 1, 2008, China will adopt a uniform tax rate of 25.0% for all enterprises (including foreign-invested enterprises) and revoke the current tax exemption, reduction and preferential treatments applicable to foreign-invested enterprises. However, a preferential tax rate of 15.0% for high and new technology enterprises and current preferential tax treatments for foreign-

 

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invested enterprises would be grandfathered for a period of five years following the effective date of the EIT Law. The EIT Law applies to all of our subsidiaries, including Hainan Simcere, Nanjing Simcere and Yantai Medgenn, three of our subsidiaries that are currently both high and new technology enterprises and foreign-invested enterprises. Any future increase in the enterprise income tax rate applicable to our PRC operating subsidiaries or other adverse tax treatments, such as the discontinuation of preferential tax treatments, would have a material adverse effect on our results of operations and financial condition.

Fluctuation in the value of the Renminbi may have a material adverse effect on your investment.

The change in value of the Renminbi against the U.S. dollar, Euro and other currencies is affected by, among other things, changes in China’s political and economic conditions. On July 21, 2005, the PRC government changed its decade-old policy of pegging the value of the Renminbi to the U.S. dollar. Under the new policy, the Renminbi is permitted to fluctuate within a narrow and managed band against a basket of certain foreign currencies. This change in policy has resulted in an approximately 7.0% appreciation of Renminbi against U.S. dollar between July 21, 2005 and March 20, 2007.

There remains significant international pressure on the PRC government to adopt a more flexible currency policy, which could result in a further and more significant appreciation of the Renminbi against the U.S. dollar. As we rely on dividends paid to us by our operating subsidiaries, any significant revaluation of the Renminbi may have a material adverse effect on the value of, and any dividends payable on, our ADSs in foreign currency terms. For example, to the extent that we need to convert U.S. dollars we received from our initial public offering into Renminbi for our operations, appreciation of the Renminbi against the U.S. dollar would have an adverse effect on the Renminbi amount we would receive from the conversion. Conversely, if we decide to convert our Renminbi into U.S. dollars for the purpose of making payments for dividends on our ordinary shares or ADSs or for other business purposes, appreciation of the U.S. dollar against the Renminbi would have a negative effect on the U.S. dollar amount available to us. In addition, appreciation or depreciation in the value of the Renminbi relative to the U.S. dollar would affect our financial results reported in U.S. dollar terms without giving effect to any underlying change in our business or results of operations.

Governmental control of currency conversion may affect the value of your investment.

The PRC government imposes controls on the convertibility of the Renminbi into foreign currencies and, in certain cases, the remittance of currency out of China. We receive all our revenues in Renminbi. Under our current corporate structure, our income is primarily derived from dividend payments from our PRC subsidiaries. Shortages in the availability of foreign currency may restrict the ability of our PRC subsidiaries to remit sufficient foreign currency to pay dividends or other payments to us, or otherwise satisfy their foreign currency-denominated obligations. Under existing PRC foreign exchange regulations, payments of current account items, including profit distributions, interest payments and expenditures from trade related transactions, can be made in foreign currencies without prior approval from SAFE by complying with certain procedural requirements. However, approval from SAFE or its local branch is required where Renminbi is to be converted into foreign currency and remitted out of China to pay capital expenses such as the repayment of loans denominated in foreign currencies. The PRC government may also at its discretion restrict access in the future to foreign currencies for current account transactions. If the foreign exchange control system prevents us from obtaining sufficient foreign currency to satisfy our currency demands, we may not be able to pay dividends in foreign currencies to our shareholders, including holders of our ADSs.

Any future outbreak of severe acute respiratory syndrome or avian influenza in China, or similar adverse public health developments, may severely disrupt our business and operations.

From December 2002 to June 2003, China and other countries experienced an outbreak of a new and highly contagious form of atypical pneumonia now known as severe acute respiratory syndrome,

 

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or SARS. On July 5, 2003, the World Health Organization declared that the SARS outbreak had been contained. Since September 2003, however, a number of isolated new cases of SARS have been reported, most recently in central China in April 2004. During May and June of 2003, many businesses in China were temporarily closed by the PRC government to prevent transmission of SARS. In addition, in 2005, there have been reports on the occurrences of avian influenza in various parts of China, including a few confirmed human cases that resulted in fatalities. Any prolonged recurrence of avian influenza, SARS or other adverse public health developments in China may have a material adverse effect on our business operations. These could include our ability to travel or ship our products within China, as well as temporary closure of our manufacturing facilities. Such closures or travel or shipment restrictions would severely disrupt our business operations and adversely affect our results of operations. We have not adopted any written preventive measures or contingency plans to combat any future outbreak of avian influenza, SARS or any other epidemic.

Risks Related to This Offering

There has been no public market for our ordinary shares or ADSs prior to this offering, and you may not be able to resell our ADSs at or above the price you paid, or at all.

Prior to this initial public offering, there has been no public market for our ordinary shares or ADSs. Our ADSs have been approved for listing on the New York Stock Exchange. Our ordinary shares will not be listed on any exchange or quoted for trading on any over-the-counter trading system. If an active trading market for our ADSs does not develop after this offering, the market price and liquidity of our ADSs will be materially and adversely affected.

The initial public offering price for our ADSs will be determined by negotiations between us and the underwriters and may bear no relationship to the market price for our ADSs after this initial public offering. We cannot assure you that an active trading market for our ADSs will develop or that the market price of our ADSs will not decline below the initial public offering price.

The market price for our ADSs may be volatile.

The market price for our ADSs is likely to be highly volatile and subject to wide fluctuations in response to factors including the following:

 

  Ÿ  

announcements of technological or competitive developments;

 

  Ÿ  

regulatory developments in China affecting us, our customers or our competitors;

 

  Ÿ  

announcements regarding patent litigation or the issuance of patents to us or our competitors;

 

  Ÿ  

actual or anticipated fluctuations in our quarterly operating results;

 

  Ÿ  

changes in financial estimates by securities research analysts;

 

  Ÿ  

changes in the economic performance or market valuations of other pharmaceutical companies;

 

  Ÿ  

addition or departure of our executive officers and key research personnel;

 

  Ÿ  

release or expiry of lock-up or other transfer restrictions on our outstanding ordinary shares or ADSs; and

 

  Ÿ  

sales or perceived sales of additional ordinary shares or ADSs.

In addition, the securities market has from time to time experienced significant price and volume fluctuations that are not related to the operating performance of particular companies. These market fluctuations may also have a material adverse effect on the market price of our ADSs.

 

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Because the initial public offering price is substantially higher than our net tangible book value per share, you will incur immediate and substantial dilution.

If you purchase ADSs in this offering, you will pay more for your ADSs than the amount paid by our existing shareholders for their ordinary shares on a per ADS basis. As a result, you will experience immediate and substantial dilution of approximately $             per ADS (assuming no exercise by the underwriters of options to acquire additional ADSs), representing the difference between our net tangible book value per ADS as of December 31, 2006, after giving effect to this offering and an assumed initial public offering price of $             per ADS, the midpoint of the range shown on the front cover page of this prospectus. In addition, you may experience further dilution to the extent that our ordinary shares are issued upon the exercise of share options. See “Dilution” for a more complete description of how the value of your investment in our ADSs will be diluted upon completion of this offering.

Substantial future sales or perceived sales of our ADSs in the public market could cause the price of our ADSs to decline.

Sales of our ADSs or ordinary shares in the public market after this offering, or the perception that these sales could occur, could cause the market price of our ADSs to decline. Upon completion of this offering, we will have              ordinary shares outstanding, including              ordinary shares represented by              ADSs. All ADSs sold in this offering will be freely transferable without restriction or additional registration under the Securities Act of 1933, as amended, or the Securities Act. The remaining ordinary shares outstanding after this offering will be available for sale, upon the expiration of the 180-day lock-up period beginning from the date of this prospectus and, in the case of the ordinary shares that certain option holders will receive when they exercise their share options, until the later of (i) November 15, 2007, the first anniversary of the grant date, and (ii) the expiration of the aforementioned 180-day lock-up period, subject to volume and other restrictions as applicable under Rule 144 and Rule 701 under the Securities Act. Any or all of these shares (other than those held by certain option holders) may be released prior to expiration of the lock-up period at the discretion of the lead underwriter. To the extent shares are released before the expiration of the lock-up period and these shares are sold into the market, the market price of our ADSs could decline.

In addition, Assure Ahead Investment Limited or its transferees and assignees will have the right to cause us to register the sale of their shares under the Securities Act upon the occurrence of certain circumstances. See “Description of Share Capital.” Registration of these shares under the Securities Act would result in these shares becoming freely tradable without restriction under the Securities Act immediately upon the effectiveness of the registration. Sales of these registered shares in the public market could cause the price of our ADSs to decline.

Our articles of association contain anti-takeover provisions that could discourage a third party from acquiring us, which could limit our shareholders’ opportunity to sell their shares, including ordinary shares represented by our ADSs, at a premium.

We have adopted our second amended and restated articles of association, which will become effective immediately upon completion of this offering. Our new articles of association limit the ability of others to acquire control of our company or cause us to engage in change-of-control transactions. These provisions could have the effect of depriving our shareholders of an opportunity to sell their shares at a premium over prevailing market prices by discouraging third parties from seeking to obtain control of our company in a tender offer or similar transaction. For example, our board of directors has the authority, without further action by our shareholders, to issue preferred shares. These preferred shares may have better voting rights than our ordinary shares, in the form of ADSs or otherwise, and could be issued quickly with terms calculated to delay or prevent a change in control of our company or

 

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make removal of management more difficult. If our board of directors decides to issue preferred shares, the price of our ADSs may fall and the voting rights of the holders of our ordinary shares and ADSs may be diluted. See “Description of Share Capital—Issuance of Additional Preferred Shares.”

Certain actions require the approval of a supermajority of at least two-thirds of our board of directors which, among other things, would allow our non-independent directors to block a variety of actions or transactions, such as a merger, asset sale or other change of control, even if all of our independent directors unanimously voted in favor of such action, thereby further depriving our shareholders of an opportunity to sell their shares at a premium. See “Description of Share Capital—Actions Requiring the Approval of a Supermajority of our Board of Directors.”

Holders of ADSs have fewer rights than shareholders and must act through the depositary to exercise those rights.

Holders of ADSs do not have the same rights of our shareholders and may only exercise the voting rights with respect to the underlying ordinary shares in accordance with the provisions of the deposit agreement. Under our second amended and restated memorandum and articles of association, the minimum notice period required to convene a general meeting is seven days. When a general meeting is convened, you may not receive sufficient notice of a shareholders’ meeting to permit you to withdraw your ordinary shares to allow you to cast your vote with respect to any specific matter. In addition, the depositary and its agents may not be able to send voting instructions to you or carry out your voting instructions in a timely manner. We will make all reasonable efforts to cause the depositary to extend voting rights to you in a timely manner, but we cannot assure you that you will receive the voting materials in time to ensure that you can instruct the depositary to vote your ADSs. Furthermore, the depositary and its agents will not be responsible for any failure to carry out any instructions to vote, for the manner in which any vote is cast or for the effect of any such vote. As a result, you may not be able to exercise your right to vote and you may lack recourse if your ADSs are not voted as you requested. In addition, in your capacity as an ADS holder, you will not be able to call a shareholders’ meeting.

You may be subject to limitations on transfers of your ADSs.

Your ADSs are transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary deem it advisable to do so because of any requirement of law or of any government or governmental body, or under any provision of the deposit agreement, or for any other reason.

Your right to participate in any future rights offerings may be limited, which may cause dilution to your holdings and you may not receive cash dividends if it is impractical to make them available to you.

We may from time to time distribute rights to our shareholders, including rights to acquire our securities. However, we cannot make rights available to you in the United States unless we register the rights and the securities to which the rights relate under the Securities Act or an exemption from the registration requirements is available. Also, under the deposit agreement, the depositary bank will not make rights available to you unless the distribution to ADS holders of both the rights and any related securities are either registered under the Securities Act, or exempted from registration under the Securities Act. We are under no obligation to file a registration statement with respect to any such rights or securities or to endeavor to cause such a registration statement to be declared effective. Moreover, we may not be able to establish an exemption from registration under the Securities Act. Accordingly, you may be unable to participate in our rights offerings and may experience dilution in your holdings.

 

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In addition, the depositary of our ADSs has agreed to pay to you the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses. You will receive these distributions in proportion to the number of ordinary shares your ADSs represent. However, the depositary may, at its discretion, decide that it is inequitable or impractical to make a distribution available to any holders of ADSs. For example, the depositary may determine that it is not practicable to distribute certain property through the mail, or that the value of certain distributions may be less than the cost of mailing them. In these cases, the depositary may decide not to distribute such property and you will not receive such distribution.

We are a Cayman Islands company and, because judicial precedent regarding the rights of shareholders is more limited under Cayman Islands law than that under U.S. law, you may have less protection for your shareholder rights than you would under U.S. law.

Our corporate affairs are governed by our second amended and restated memorandum and articles of association, the Cayman Islands Companies Law (as amended) and the common law of the Cayman Islands. The rights of shareholders to take action against the directors, actions by minority shareholders and the fiduciary responsibilities of our directors to us under Cayman Islands law are to a large extent governed by the common law of the Cayman Islands. The common law of the Cayman Islands is derived in part from comparatively limited judicial precedent in the Cayman Islands as well as that from English common law, which has persuasive, but not binding, authority on a court in the Cayman Islands. The rights of our shareholders and the fiduciary responsibilities of our directors under Cayman Islands law are not as clearly established as they would be under statutes or judicial precedent in some jurisdictions in the United States. In particular, the Cayman Islands has a less developed body of securities laws than the United States. In addition, some U.S. states, such as Delaware, have more fully developed and judicially interpreted bodies of corporate law than the Cayman Islands.

As a result of all of the above, public shareholders may have more difficulty in protecting their interests in the face of actions taken by management, members of the board of directors or controlling shareholders than they would as shareholders of a U.S. public company.

You may have difficulty enforcing judgments obtained against us.

We are a Cayman Islands company and substantially all of our assets are located outside of the United States. Substantially all of our current operations are conducted in the PRC. In addition, most of our directors and officers are nationals and residents of countries other than the United States. As a result, it may be difficult for you to effect service of process within the United States upon these persons. It may also be difficult for you to enforce in U.S. courts judgments obtained in U.S. courts based on the civil liability provisions of the U.S. federal securities laws against us and our officers and directors, most of whom are not residents in the United States and the substantial majority of whose assets are located outside of the United States. In addition, there is uncertainty as to whether the courts of the Cayman Islands or the PRC would recognize or enforce judgments of U.S. courts against us or such persons predicated upon the civil liability provisions of the securities laws of the United States or any state and it is uncertain whether such Cayman Islands or PRC courts would be competent to hear original actions brought in the Cayman Islands or the PRC against us or such persons predicated upon the securities laws of the United States or any state. See “Enforcement of Civil Liabilities.”

We have not determined any specific use for a portion of the net proceeds to us from this offering and we may use such portion of the net proceeds in ways with which you may not agree.

We have not allocated a portion of the net proceeds to us from this offering to any specific purpose. Rather, our management will have considerable discretion in the application of such portion

 

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of the net proceeds received by us. See “Use of Proceeds.” You will not have the opportunity, as part of your investment decision, to assess whether such proceeds are being used appropriately. You must rely on the judgment of our management regarding the application of such proceeds we receive from this offering. Such proceeds we receive may be used for corporate purposes that do not improve our profitability or increase our ADS price. Such proceeds we receive from this offering may also be placed in investments that do not produce income or that may lose value.

We will incur increased costs as a result of being a public company.

As a public company, we will incur a significantly higher level of legal, accounting and other expenses than we did as a private company. In addition, the Sarbanes-Oxley Act of 2002, as well as new rules subsequently implemented by the Securities and Exchange Commission, or the SEC, and the New York Stock Exchange, have required changes in corporate governance practices of public companies. We expect these new rules and regulations to increase our legal, accounting and financial compliance costs and to make certain corporate activities more time-consuming and costly. We are currently evaluating and monitoring developments with respect to these new rules, and we cannot predict or estimate the amount of additional costs we may incur or the timing of such costs.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements that relate to our current expectations and views of future events. The forward-looking statements are contained principally in the sections entitled “Prospectus Summary,” “Risk Factors,” “Use of Proceeds,” “Recent Developments,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, “Our Industry” and “Business.” These statements relate to events that involve known and unknown risks, uncertainties and other factors, including those listed under “Risk Factors,” which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, these forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements include, among other things, statements relating to:

 

  Ÿ  

our anticipated growth strategies;

 

  Ÿ  

our future business development, results of operations and financial condition;

 

  Ÿ  

market acceptance of our products and product candidates;

 

  Ÿ  

our ability to effectively protect our intellectual property and trade secrets and not infringe on the intellectual property and trade secrets of others;

 

  Ÿ  

the sufficiency of our existing and future intellectual property right protections;

 

  Ÿ  

our ability to obtain regulatory approval for products that we develop;

 

  Ÿ  

our ability to successfully develop and improve products;

 

  Ÿ  

changes in the healthcare industry in China, including increased availability of funding for medical insurance coverage and the inclusion of additional medicines in the national and provincial Medical Insurance Catalogs;

 

  Ÿ  

our ability to manage our expansion of operations;

 

  Ÿ  

environmental compliance costs and liabilities;

 

  Ÿ  

competition from other manufacturers of pharmaceutical products;

 

  Ÿ  

the expected growth for the pharmaceutical industry in China;

 

  Ÿ  

our ability to obtain permits and licenses to carry on our business; and

 

  Ÿ  

fluctuations in general economic and business conditions in China.

This prospectus also contains data related to the pharmaceutical market in China and we have derived such data from reports of the Cancer Foundation of China, the Freedonia Group, IMS Health, the PRC Ministry of Health, the PRC National Bureau of Statistics, the PRC National Center for Biotechnology Development, the PRC National Development and Reform Commission and the Southern Pharmaceutical Economic Research Institute. These market data include projections that are based on a number of assumptions. Unlike in the United States, there is limited authoritative data on the pharmaceutical market in China, particularly on a nationwide basis. In addition, any data that is available may not be current. The pharmaceutical market in China may not grow at the rates projected by the market data, or at all. The failure of the market to grow at the projected rates may have a

 

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material adverse effect on our business and the market price of our ADSs. In addition, the rapidly changing nature of the pharmaceutical market subjects any projections or estimates relating to the growth prospects or future condition of our market to significant uncertainties. If any one or more of the assumptions underlying the market data turns out to be incorrect, actual results may differ from the projections based on these assumptions. You should not place undue reliance on these forward-looking statements.

The forward-looking statements made in this prospectus relate only to events or information as of the date on which the statements are made in this prospectus. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect.

 

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USE OF PROCEEDS

We estimate that we will receive net proceeds from this offering of approximately $             million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. These estimates are based upon an assumed initial offering price of $             per ADS, the midpoint of the range shown on the front cover page of this prospectus. A $1.00 increase (decrease) in the assumed initial public offering price of $             per ADS would increase (decrease) the net proceeds to us from this offering by $             million, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us and assuming no exercise of the underwriters’ over-allotment option and no other change to the number of ADSs offered by us as set forth on the cover page of this prospectus.

We intend to use the net proceeds we receive from this offering for the following purposes:

 

  Ÿ  

approximately $52.0 million to fund our research and development efforts as follows;

 

   

approximately $35.0 million to fund joint pre-clinical studies and clinical trials in China with international pharmaceutical and biotechnology companies to develop innovative pharmaceuticals for the China market. In particular, we plan to spend approximately $5.0 million to fund the joint research and development of an anti-cancer pharmaceutical with Advenchen Laboratories LLC, or Advenchen, a pharmaceutical research and development company in the United States, based on a chemical compound owned by Advenchen. While we are in active discussions with several other international pharmaceutical and biotechnology companies regarding potential research and development projects, no other specific project has been identified, nor have we entered into any other definitive agreement for any other project. We anticipate that these proceeds will allow us to fund such research and development efforts for at least the next 24 months. If additional funding is needed, we plan to use cash generated from operating activities to fund such need;

 

   

approximately $13.0 million to fund the research and development of potential indications for Endu, the Phase IV clinical trials for Endu, and the improvement of delivery mechanisms or dosage formulations for Endu. We anticipate that these proceeds together with our existing cash will allow us to perform Phase IV clinical trials for Endu for at least the next 24 months; and

 

   

approximately $4.0 million to purchase research equipment;

 

  Ÿ  

approximately $30.0 million to repay certain of our outstanding short-term bank borrowings;

 

  Ÿ  

approximately $14.0 million to fund our GMP-certified production facilities, including approximately $9.0 million to build additional GMP-certified production facilities and purchase additional production equipment to expand our production capacity of Endu, and approximately $5.0 million to revamp our existing production facilities and to purchase additional equipment to sustain compliance with GMP requirements; and

 

  Ÿ  

approximately $13.0 million to expand our marketing force and strengthen our marketing efforts, including initiating additional promotional and educational campaigns targeting healthcare practitioners, pharmacies, patients and the general public to increase awareness of our products and to increase the use of print and television advertisements and other promotional methods to promote our brand names.

 

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The following table sets forth a summary of our outstanding short-term bank borrowings as of March 20, 2007, which we intend to repay using part of the proceeds we will receive from this offering:

 

Lender

 

Date of Borrowing

 

Due Date

  Principal
(in RMB)
  Principal
(in USD)
  Interest
Rate
 

Nanjing Commercial Bank

  May 30, 2006   May 29, 2007   25,000,000   3,203,444   5.9904 %

Nanjing Commercial Bank

  June 12, 2006   June 12, 2007   40,000,000   5,125,511   5.9904 %

Nanjing Commercial Bank

  August 17, 2006   August 14, 2007   15,000,000   1,922,067   5.9904 %

Nanjing Commercial Bank

  November 15, 2006   November 15, 2007   24,000,000   3,075,307   6.4260 %

CITIC Industrial Bank

  October 27, 2006   March 28, 2007   6,500,000   832,896   5.5800 %

CITIC Industrial Bank

  December 7, 2006   March 27, 2007   4,500,000   576,620   5.5800 %

China Merchants Bank

  October 31, 2006   April 30, 2007   30,000,000   3,844,133   5.5800 %

Bank of China

  July 25, 2006   July 13, 2007   11,000,000   1,409,516   5.8500 %

Bank of China

  August 15, 2006   August 11, 2007   29,000,000   3,715,995   5.8500 %

Agricultural Bank of China

  December 31, 2006   December 30, 2007   30,000,000   3,844,133   6.1200 %

China Construction Bank

  May 17, 2006   May 16, 2007   5,000,000   640,689   5.8500 %

Shandong Yantai Government Interest Free Loan

  September 19, 2006   May 4, 2007   3,000,000   384,413   Nil  

Shandong Yantai Government Interest Free Loan

  September 19, 2006   December 30, 2007   3,000,000   384,413   Nil  

We may also use the remaining portion of the net proceeds we receive from this offering for other general corporate purposes and for potential acquisitions of, or investments in, products, product candidates, businesses and technologies that we believe will complement our current operations and our expansion strategies. We do not have specific plans and are not currently engaged in any discussions or negotiations for any acquisitions.

The foregoing use of our net proceeds from this offering represents our current intentions based upon our present plans and business condition. The amounts and timing of any expenditure will vary depending on the amount of cash generated by our operations, competitive and technological developments and the rate of growth, if any, of our business. Accordingly, our management will have significant discretion in the allocation of the net proceeds we will receive from this offering. Depending on future events and other changes in the business climate, we may determine at a later time to use the net proceeds for different purposes. Pending their use, we intend to place our net proceeds in short-term bank deposits.

In utilizing the proceeds of this offering, as an offshore holding company, we are permitted, under PRC laws and regulations, to provide funding to our PRC subsidiaries only through loans or capital contributions and to other entities only through loans. Subject to satisfaction of applicable government registration and approval requirements, we may extend inter-company loans to our PRC subsidiaries or make additional capital contributions to our PRC subsidiaries to fund their capital expenditures or working capital. We cannot assure you that we will be able to obtain these government registrations or

 

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approvals on a timely basis, if at all. See “Risk Factors—Risks Related to Doing Business in China—PRC regulation of loans and direct investment by offshore holding companies to PRC entities may delay or prevent us from using the proceeds of this offering to make loans or additional capital contributions to our PRC operating subsidiaries and affiliated entities, which could adversely and materially affect our liquidity and our ability to fund and expand our business.”

We will not receive any of the proceeds from the sale of ADSs by the selling shareholders.

 

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DIVIDEND POLICY

Our board of directors has complete discretion on whether to pay dividends. Even if our board of directors decides to pay dividends, the form, frequency and amount will depend upon our future operations and earnings, capital requirements and surplus, general financial condition, contractual restrictions and other factors that the board of directors may deem relevant.

Since our incorporation, we have never declared or paid any dividends, nor do we have any present plan to pay any cash dividends on our ordinary shares in the foreseeable future. We do not have any present plan to pay any cash dividends on our ordinary shares in the foreseeable future. We currently intend to retain most, if not all, of our available funds and any future earnings to operate and expand our business.

If we pay any dividends, we will pay our ADS holders to the same extent as holders of our ordinary shares, subject to the terms of the deposit agreement, including the fees and expenses payable thereunder. See “Description of American Depositary Shares.” Cash dividends on our ordinary shares, if any, will be paid in U.S. dollars.

 

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CAPITALIZATION

The following table sets forth our capitalization as of December 31, 2006:

 

  Ÿ  

on an actual basis; and

 

  Ÿ  

on an as adjusted basis to reflect the issuance and sale of              ordinary shares in the form of ADSs by us in this offering, assuming an initial public offering price of $             per ADS, the midpoint of the estimated range of the initial public offering price, after deducting estimated underwriting discounts and commissions and estimated aggregate offering expenses payable by us and assuming no exercise of the underwriters’ over-allotment option and no other change to the number of ADSs sold by us as set forth on the cover page of this prospectus.

The as adjusted information below is illustrative only and our capitalization following the completion of this offering is subject to adjustment based on the actual initial public offering price of our ADSs and other terms of this offering determined at pricing. You should read this table together with our consolidated financial statements and the related notes included elsewhere in this prospectus and the information under “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

     As of December 31, 2006
     Actual    As adjusted
         RMB            USD            RMB            USD    
     (in thousands)

Shareholders’ equity:

           

Share capital—ordinary shares, $0.01 par value, 500 million shares authorized and 100 million shares issued and outstanding(1)

   7,909    1,013      

Additional paid-in capital(2)

   265,964    34,080      

Retained earnings(3)

   168,867    21,639    168,867    21,639
                   

Total shareholders’ equity(2)

   442,740    56,732      
                   

Total capitalization(2)

   442,740    56,732      
                   

(1) Excludes 10.0 million ordinary shares issuable upon the exercise of options outstanding as of December 31, 2006 and 2.0 million ordinary shares reserved for future issuance under our 2006 share incentive plan. As of March 22, 2007, we had issued options to purchase 11,045,000 ordinary shares and had 955,000 ordinary shares reserved for future issuance under our 2006 share incentive plan.
(2) Assuming the number of ADSs offered by us as set forth on the cover page of this prospectus remains the same, and after deduction of underwriting discounts and commissions and the estimated offering expenses payable by us, a $1.00 increase (decrease) in the assumed initial public offering price of $             per ADS would increase (decrease) each of additional paid-in capital, total shareholders’ equity and total capitalization by $             million.
(3) Amount includes restricted reserve of RMB49.9 million ($6.4 million) which is not distributable as cash dividends.

 

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DILUTION

If you invest in our ADSs, your interest will be diluted to the extent of the difference between the initial public offering price per ADS and our net tangible book value per ADS after this offering. Dilution results from the fact that the initial public offering price per ordinary share is substantially in excess of the book value per ordinary share attributable to the existing shareholders for our presently outstanding ordinary shares.

Our net tangible book value as of December 31, 2006 was approximately RMB179.0 million ($22.9 million), or RMB1.79 ($0.23) per ordinary share and $             per ADS. Net tangible book value represents the amount of our total consolidated tangible assets, minus the amount of our total consolidated liabilities. Without taking into account any other changes in such net tangible book value after December 31, 2006, other than to give effect to our sale of the ADSs offered in this offering, at the assumed initial public offering price of $             per ADS, the midpoint of the estimated range of the initial public offering price, and after deduction of underwriting discounts and commissions and estimated offering expenses of this offering payable by us, our adjusted net tangible book value as of December 31, 2006 would have increased to $             million or $             per ordinary share and $             per ADS. This represents an immediate increase in net tangible book value of $             per ordinary share and $             per ADS, to the existing shareholder and an immediate dilution in net tangible book value of $             per ordinary share and $             per ADS, to investors purchasing ADSs in this offering. The following table illustrates such per share dilution:

 

Estimated initial public offering price per ordinary share

   $             

Net tangible book value per ordinary share as of December 31, 2006

   $   0.23

Amount of dilution in net tangible book value per ordinary share to new investors in this offering

   $             

Amount of dilution in net tangible book value per ADS to new investors in this offering

   $             

A $1.00 increase (decrease) in the assumed initial public offering price of $             per ADS would increase (decrease) our pro forma net tangible book value after giving effect to the offering by $             million, or by $             per ordinary share and by $             per ADS, assuming no change to the number of ADSs offered by us as set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions and other expenses of the offering. The pro forma information discussed above is illustrative only. Our net tangible book value following the completion of this offering is subject to adjustment based on the actual initial public offering price of our ADSs and other terms of this offering determined at pricing.

 

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The following table summarizes, on a pro forma basis as of December 31, 2006, the differences between existing shareholders and the new investors with respect to the number of ordinary shares (in the form of ADSs or shares) purchased from us, the total consideration paid and the average price per ordinary share and per ADS. In the case of ADS purchased by new investors, the consideration and price amounts are paid before deducting estimated underwriting discounts and commissions and estimated offering expenses, assuming an initial public offering price of $             per ADS, the midpoint of the estimated range of the initial public offering price. The total number of ordinary shares in the following table does not include ordinary shares underlying the ADSs issuable upon the exercise of the over-allotment option granted to the underwriters. The information in the following table is illustrative only and the total consideration paid and the average price per ordinary share and per ADS for new investors is subject to adjustment based on the actual initial public offering price of our ADSs and other terms of this offering determined at pricing.

 

    

Ordinary Shares

Purchased

    Total Consideration    

Average Price

Per Ordinary

Share

  

Average Price

Per ADSs

     Number    Percent     Amount    Percent       

Existing shareholders

                   %   $                              %   $                 $             

New investors

                   %                   %   $                 $             
                             

Total

                   %   $                              %     

A $1.00 increase (decrease) in the assumed initial public offering price of $             per ADS would increase (decrease) total consideration paid by new investors, total consideration paid by all shareholders and the average price per ADS paid by all shareholders by $             million, $             million and $            , respectively, assuming no change in the number of ADSs sold by us as set forth on the cover page of this prospectus and without deducting underwriting discounts and commissions and other expenses of the offering.

The dilution to new investors will be $             per ordinary share and $             per ADS, if the underwriters exercise in full their option to purchase additional ADSs.

The discussion and tables above also assume no exercise of any outstanding share options. As of March 22, 2007, there were 10.0 million ordinary shares issuable upon the exercise of outstanding share options at a weighted average exercise price of $4.20 per share, 1,045,000 ordinary shares issuable upon the exercise of outstanding share options at a weighted average exercise price equal to the midpoint of the estimated range of the initial public offering price and 955,000 additional ordinary shares available for future issuance upon the exercise of future grants under our 2006 share incentive plan. To the extent that any of these options are exercised, there will be further dilution to new investors.

 

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EXCHANGE RATE INFORMATION

Our business is primarily conducted in China and all of our revenues are denominated in Renminbi. Periodic reports made to shareholders will be expressed in Renminbi with translations of Renminbi amounts into U.S. dollars at the then current exchange rate solely for the convenience of the reader. Conversions of Renminbi into U.S. dollars in this prospectus are based on the noon buying rate in The City of New York for cable transfers of Renminbi as certified for customs purposes by the Federal Reserve Bank of New York. Unless otherwise noted, all translations from Renminbi to U.S. dollars and from U.S. dollars to Renminbi in this prospectus were made at a rate of RMB7.8041 to $1.00, the noon buying rate in effect as of December 29, 2006. We make no representation that any Renminbi or U.S. dollar amounts could have been, or could be, converted into U.S. dollars or Renminbi, as the case may be, at any particular rate, the rates stated below, or at all. The PRC government imposes control over its foreign currency reserves in part through direct regulation of the conversion of Renminbi into foreign exchange and through restrictions on foreign trade. On March 20, 2007, the noon buying rate was RMB7.7320 to $1.00.

The following table sets forth information concerning exchange rates between the RMB and the U.S. dollar for the periods indicated.

 

     Noon Buying Rate

Period

   Period End    Average(1)    Low    High
     (RMB per $1.00)

2002

   8.2800    8.2770    8.2800    8.2669

2003

   8.2767    8.2772    8.2800    8.2765

2004

   8.2765    8.2768    8.2771    8.2765

2005

   8.0702    8.1826    8.2765    8.0702

2006

   7.8041    7.9579    8.0702    7.8041

September

   7.9040    7.9334    7.9533    7.8965

October

   7.8785    7.9018    7.9168    7.8728

November

   7.8340    7.8622    7.8750    7.8303

December

   7.8041    7.8220    7.8350    7.8041

2007

           

January

   7.7714    7.7876    7.8127    7.7705

February

   7.7410    7.7502    7.7632    7.7410

March (through March 20)

   7.7320    7.7403    7.7454    7.7280

(1) Annual averages are calculated from month-end rates. Monthly averages are calculated using the average of the daily rates during the relevant period.

 

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ENFORCEABILITY OF CIVIL LIABILITIES

We are incorporated in the Cayman Islands to take advantage of certain benefits associated with being a Cayman Islands exempted company, such as:

 

  Ÿ  

political and economic stability;

 

  Ÿ  

an effective judicial system;

 

  Ÿ  

a favorable tax system;

 

  Ÿ  

the absence of exchange control or currency restrictions; and

 

  Ÿ  

the availability of professional and support services.

However, certain disadvantages accompany incorporation in the Cayman Islands. These disadvantages include:

 

  Ÿ  

the Cayman Islands has a less developed body of securities laws as compared to the United States and provides significantly less protection to investors; and

 

  Ÿ  

Cayman Islands companies do not have standing to sue before the federal courts of the United States.

Our constituent documents do not contain provisions requiring that disputes, including those arising under the securities laws of the United States, between us, our officers, directors and shareholders, be arbitrated.

Substantially all of our current operations are conducted in China, and substantially all of our assets are located in China. A majority of our directors and officers are nationals or residents of jurisdictions other than the United States and a substantial portion of their assets are located outside the United States. As a result, it may be difficult for a shareholder to effect service of process within the United States upon us or such persons, or to enforce against us or them judgments obtained in United States courts, including judgments predicated upon the civil liability provisions of the securities laws of the United States or any state in the United States.

We have appointed CT Corporation System as our agent to receive service of process with respect to any action brought against us in the United States District Court for the Southern District of New York under the federal securities laws of the United States or of any state in the United States or any action brought against us in the Supreme Court of the State of New York in the County of New York under the securities laws of the State of New York.

Walkers, our counsel as to Cayman Islands law, and Jingtian & Gongcheng, our counsel as to PRC law, have advised us, respectively, that there is uncertainty as to whether the courts of the Cayman Islands and the PRC, respectively, would:

 

  Ÿ  

recognize or enforce judgments of United States courts obtained against us or our directors or officers predicated upon the civil liability provisions of the securities laws of the United States or any state in the United States; or

 

  Ÿ  

entertain original actions brought in each respective jurisdiction against us or our directors or officers predicated upon the securities laws of the United States or any state in the United States.

Walkers has further advised us that a final and conclusive judgment in the federal or state courts of the United States under which a sum of money is payable, other than a sum payable in respect of taxes, fines, penalties or similar fiscal or revenue obligations and which was neither obtained in a manner nor is of a kind enforcement of which is contrary to natural justice or the public policy of the Cayman Islands, may be subject to enforcement proceedings as a debt in the courts of the Cayman Islands under the common law.

 

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Jingtian & Gongcheng has advised us further that the recognition and enforcement of foreign judgments are provided for under the PRC Civil Procedures Law. PRC courts may recognize and enforce foreign judgments in accordance with the requirements of the PRC Civil Procedures Law based either on treaties between the PRC and the country where the judgment is made or on reciprocity between jurisdictions, provided that the foreign judgments do not violate the basic principles of laws of the PRC or its sovereignty, security or social and public interests.

 

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SELECTED CONSOLIDATED FINANCIAL DATA

The following selected consolidated statements of income and other consolidated financial data for the three years ended December 31, 2004, 2005 and 2006, other than the earnings per ADS data, and the consolidated balance sheet data as of December 31, 2004, 2005 and 2006 have been derived from our audited consolidated financial statements, which are included elsewhere in this prospectus. The following selected consolidated statements of income and other consolidated financial data for the years ended December 31, 2002 and 2003 and the consolidated balance sheet data as of December 31, 2002 and 2003 have been derived from our unaudited consolidated financial statements, which are not included in this prospectus.

You should read the selected consolidated financial data in conjunction with those financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus. Our consolidated financial statements are prepared and presented in accordance with U.S. GAAP. Our historical results do not necessarily indicate our results expected for any future periods.

 

    Year Ended December 31,  
      2002         2003       2004     2005     2006     2006  
    RMB     RMB     RMB     RMB     RMB     USD  
    (in thousands, except share, per share and per ADS data)  

Consolidated Statements of Income Data

           

Product revenues

  303,928     464,905     563,575     736,220     947,797     121,449  

Other revenue—VAT refunds

  213     913     623     794     2,809     360  

Gross profit

  209,452     321,756     410,403     565,940     760,046     97,391  

Operating expenses:

           

Research and development expenses

  (4,770 )   (11,716 )   (19,907 )   (16,288 )   (34,289 )   (4,394 )

Sales, marketing and distribution expenses

  (123,284 )   (192,751 )   (230,865 )   (312,426 )   (442,757 )   (56,734 )

General and administrative expenses

  (46,669 )   (84,840 )   (77,593 )   (87,139 )   (98,249 )   (12,589 )
                                   

Total operating expenses

  (174,723 )   (289,307 )   (328,365 )   (415,853 )   (575,295 )   (73,717 )

Income from operations

  34,729     32,449     82,038     150,087     184,751     23,674  

Net income(1)

  8,887     24,390     46,245     102,745     172,258     22,072  

Earnings per share — basic and diluted

  0.13     0.35     0.67     1.49     1.86     0.24  

Earnings per ADS — basic and diluted

           

Weighted average number of shares

  69,000,000     69,000,000     69,000,000     69,000,000     92,695,890     92,695,890  

(1) In March 2006, certain of our operating subsidiaries became eligible for certain exemptions from income tax. In September 2006, we acquired 80.0% of the equity interest of Yantai Medgenn, which is also eligible for such tax exemption. The effect of the income tax exemptions on our earnings per share in 2006 was RMB0.42 ($0.05). Prior to this period, there was no tax exemption in place. Without these exemptions, our basic and diluted earnings per share in 2006 would have been RMB1.44 ($0.19).

 

     Year Ended December 31,
       2002        2003        2004        2005        2006  
     (in percentages)

Other Consolidated Financial Data

              

Gross margin

   68.9    69.1    72.7    76.8    80.0

Operating margin

   10.9    6.97    14.5    20.4    19.5

Net margin

   2.9    5.24    8.2    13.9    18.2

 

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     As of December 31,
       2002        2003        2004        2005        2006        2006  
     RMB    RMB    RMB    RMB    RMB    USD
     (in thousands)

Consolidated Balance Sheet Data

                 

Cash

   49,052    61,193    102,672    90,060    106,027    13,586

Accounts receivable, net of allowance for doubtful accounts

   48,655    95,884    67,459    83,393    61,723    7,909

Inventories

   24,242    32,031    27,878    40,293    39,483    5,059

Amounts due from related parties

   47,202    79,576    39,890    85,575    434    55

Total current assets

   220,544    334,609    322,446    391,461    411,429    52,720

Property, plant and equipment, less accumulated depreciation

   76,082    123,173    119,558    125,365    267,054    34,220

Intangible assets, net

   —      20,310    18,020    15,731    163,148    20,905

Goodwill

   —      13,814    13,814    13,814    100,634    12,895

Total assets

   358,575    519,019    581,041    621,227    1,034,547    132,565

Short-term bank loans and borrowings

   194,500    246,330    293,000    171,000    333,000    42,670

Amounts due to related parties

   1,900    15,045    12,908    78,153    1,352    173

Total current liabilities

   266,519    385,882    456,747    421,185    568,173    72,805

Total shareholders’ equity

   67,559    108,437    119,990    192,537    442,740    56,732

 

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RECENT DEVELOPMENTS

The following is a projection of our selected preliminary unaudited financial results for the three months ending March 31, 2007. These results are subject to our normal quarter-end closing procedures and are subject to change. For additional information regarding the various risks and uncertainties inherent in projections of this type, see “Special Note Regarding Forward-Looking Statements.”

We project that we will generate total revenues ranging from approximately RMB300.0 million ($38.4 million) to RMB315.0 million ($40.4 million) in the three months ending March 31, 2007. We project that we will have income from operations ranging from approximately RMB68.0 million ($8.7 million) to RMB72.0 million ($9.2 million) and net income ranging from approximately RMB63.0 million ($8.1 million) to RMB66.0 million ($8.5 million) in the three months ending March 31, 2007.

Although full results for our fiscal quarter ending March 31, 2007 are not yet available, based upon our management accounts for January and February 2007 and the information available to us, including our assessment of the operating conditions prevailing in March 2007, and except as otherwise described in this prospectus, we do not anticipate that our results for the quarter will be adversely impacted, in the aggregate, by any material or unusual adverse events. However, our actual results may differ from our current projections. We cannot assure you that our results for the three months ending March 31, 2007 will be indicative of our full year results for 2007 or future quarterly periods. Please refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus for information regarding trends and other factors that may influence our results of operations.

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND

RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the section entitled “Selected Consolidated Financial Data” and our consolidated financial statements and the related notes included elsewhere in this prospectus. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and elsewhere in this prospectus.

Overview

We are a leading manufacturer and supplier of branded generic pharmaceuticals in the fast growing China market. We have recently focused our strategy on the development of first-to-market generic and innovative pharmaceuticals. We currently manufacture and sell 35 pharmaceutical products and are the exclusive distributor of three additional pharmaceutical products that are marketed under our brand names. Our products include antibiotics, an anti-stroke medication, anti-inflammatory pain relievers, an anti-cancer medication and other pharmaceuticals. We market and sell our products exclusively to approximately 900 regional pharmaceutical distributors, who in turn sell these products to local distributors, hospitals and retail pharmacies throughout China.

We commenced operations in March 1995 and operated our business mainly as a distributor of pharmaceutical products. Since then, we have gradually built up our research and development and manufacturing capabilities and have become one of the leading pharmaceutical companies in China that develop, manufacture and sell branded generic pharmaceuticals. To date, we have introduced a series of branded products, including our first-to-market generic anti-stroke medication Bicun, as well as our innovative pharmaceutical Endu, the first recombinant human endostatin injection approved for sale in China. Revenues from each of our top three branded pharmaceuticals, Bicun, Zailin and Yingtaiqing, exceeded RMB100.0 million ($12.8 million) in 2006, which we believe is evidence of wide market acceptance of these products in the China market.

In May 2006, we entered into a purchase agreement to acquire an 80.0% equity interest in Yantai Medgenn, a PRC pharmaceutical company engaged in the research, development, manufacture and sale of an anti-cancer drug under the name Endu. Prior to the completion of the acquisition, we began to distribute Endu as Yantai Medgenn’s exclusive distributor in July 2006. The acquisition was completed in September 2006, after which we began to manufacture Endu. See “—The Acquisition of Yantai Medgenn.” Through this acquisition, we have also acquired the patents and the rights to manufacture and sell Endu in China, as well as a GMP-certified manufacturing facility for the production of Endu.

We have experienced significant growth in our business in recent years. Our total revenues increased from RMB564.2 million in 2004 to RMB737.0 million in 2005 and to RMB950.6 million ($121.8 million) in 2006, representing a CAGR of 29.8% from 2004 to 2006. Our net income increased from RMB46.2 million in 2004 to RMB102.7 million in 2005 and to RMB172.3 million ($22.1 million) in 2006, representing a CAGR of 93.1% from 2004 to 2006.

We believe that the most significant factors that affect our financial performance and results of operations are:

 

  Ÿ  

the growth of the pharmaceutical market in China;

 

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  Ÿ  

our ability to successfully develop, acquire and launch first-to-market branded generic and innovative pharmaceuticals;

 

  Ÿ  

the extent of inclusion of our pharmaceuticals in the Medical Insurance Catalogs;

 

  Ÿ  

our ability to compete in the tender processes for purchase of medicines by state-owned and state-controlled Chinese hospitals; and

 

  Ÿ  

product pricing and price controls.

The Growth of the Pharmaceutical Market in China

With approximately one-fifth of the world’s population and a fast-growing gross domestic product, China represents a significant potential market for the pharmaceutical industry. According to the Freedonia Group, demand for pharmaceuticals in China reached RMB198.0 billion ($25.4 billion) in 2005, representing a 12.1% annual growth since 2000. The Freedonia Group expects total pharmaceutical expenditures in China to grow at a CAGR of 13.6% between 2005 and 2010. Such growth rate is significantly higher than the growth rate for the pharmaceutical industry in the rest of the world, which is projected to be at a CAGR of 5.0% to 8.0% between 2004 and 2009 according to IMS Health.

We believe the significant expected growth of the pharmaceutical market in China is due to factors such as robust economic growth and increased pharmaceutical expenditure, aging population and increased lifestyle-related diseases, government support of the pharmaceutical industry, the relatively low research and development and clinical trial costs in China as compared to developed countries, as well as the increased availability of funding for medical insurance and industry consolidation in China.

Our Ability to Successfully Develop, Acquire and Launch First-to-Market Generic and Innovative Pharmaceuticals

We believe that our proven ability to build a portfolio of first-to-market branded generic and innovative pharmaceuticals is crucial for our long-term growth and profitability, as first-to-market pharmaceuticals provide the advantage of rapid market penetration and higher profit margins. Compared to other generic pharmaceuticals, which can be sold by other pharmaceutical companies at a lower price, first-to-market generic pharmaceuticals, although not protected by intellectual property rights, are often granted a monitoring period, or have been granted a protection period under prior regulations, by the SFDA during which time the SFDA will not accept applications for new medicine certificates for pharmaceuticals with the same chemical structure, dosage form and indication. Innovative pharmaceuticals, which are protected by intellectual property rights, enjoy an even longer period of exclusivity as the validity period for an invention patent is 20 years. Our first-to-market branded generic pharmaceutical, Bicun, is an anti-stroke medication and is the first edaravone injection approved for sale in China. We estimate that Bicun held the leading market share of more than 90.0% of the total edaravone injections sold in China in 2005, based on the market research conducted by IMS Health. Our innovative anti-cancer medication Endu, is the first recombinant human endostatin injection approved for sale in China and has been used in over 400 hospitals in China since it was launched in July 2006. We believe that our ability to launch first-to-market generic and innovative pharmaceuticals, the exclusive marketing period in relation to such pharmaceuticals, coupled with our capabilities in marketing, branding and distribution, will continue to allow us to develop products that gain widespread recognition quickly and contribute to the rapid increase of our revenues and profitability.

The Extent of Inclusion of Our Pharmaceuticals in the Medical Insurance Catalogs

Eligible participants in the national basic medical insurance program in China, which consists of mostly urban residents, are entitled to reimbursement from the social medical insurance fund for up to

 

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the entire cost of medicines that are included in the national and provincial Medical Insurance Catalogs. See “Regulation of Our Industry—Reimbursement Under the National and Provincial Medical Insurance Programs.” Factors that affect the inclusion of medicines in the Medical Insurance Catalogs include whether the medicine is consumed in large volumes and commonly prescribed for clinical use in China and whether it is considered to be important in meeting the basic healthcare needs of the general public. As of March 20, 2007, 21 of our 38 products were included in the national Medical Insurance Catalog and 11 were included in the Medical Insurance Catalog of various provinces, municipalities and autonomous regions. The inclusion of a medicine in the Medical Insurance Catalogs can substantially improve the sales volume of the medicine due to the availability of third-party reimbursements. However, pharmaceuticals included in the Medical Insurance Catalogs are subject to price controls in the form of fixed retail prices or retail price ceilings, and are subject to periodical price adjustments by the relevant regulatory authorities. Such price controls, especially downward price adjustments, may negatively affect the unit price of our products. See “—Product Pricing and Price Controls.” On balance, we believe that the benefit of the inclusion of our pharmaceuticals in the Medical Insurance Catalogs outweighs the cost of such inclusion.

There can be no assurance that our products currently included in the Medical Insurance Catalogs will continue to be included in the catalogs. The removal or exclusion of our products from the Medical Insurance Catalogs may adversely affect the sales of these products. The commercial success of our new and potential products is substantially dependent on whether and to what extent reimbursement is or will be available. Our failure to obtain inclusion of our new and potential products in the Medical Insurance Catalogs may adversely affect the future sales of those products. See “Risk Factors—Risks Related to Our Company—There is no assurance that our existing products will continue to be included or new products developed by us will be included in the Medical Insurance Catalogs.

Our Ability to Compete In the Tender Processes For Purchase of Medicines by State-Owned and State-Controlled Chinese Hospitals

A substantial portion of the products we sell to our distributor customers are then sold to hospitals owned or controlled by counties or higher level government authorities in China. These hospitals must implement collective tender processes for the purchase of medicines listed in the Medical Insurance Catalogs and medicines that are consumed in large volumes and commonly prescribed for clinical uses. Factors considered by these hospitals in assessing bids include, among other things, the quality and price of the medicine and the service and reputation of the manufacturers. The collective tender process for pharmaceuticals with the same chemical composition must be conducted at least annually, and pharmaceuticals that have won in the collective tender processes previously must participate and win in the collective tender processes in the following period before new purchase orders can be issued. If we are unable to win purchase contracts through the collective tender processes in which we decide to participate, we will lose market share to our competitors, and our revenue and profitability will be adversely affected.

Product Pricing and Price Controls

Certain of our pharmaceutical products sold in China, primarily those included in the Medical Insurance Catalogs, are subject to price controls in the form of fixed prices or price ceilings. Controls over and adjustments to the retail price of a pharmaceutical may have a corresponding impact on the wholesale price of that pharmaceutical. From time to time, the PRC government publishes and updates a list of medicines that are subject to price controls, either at the national level or the provincial or regional level. Fixed prices and price ceilings on medicines are determined based on profit margins that the relevant government authorities deem reasonable, the type and quality of the medicine, its

 

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production costs, the prices of substitute medicines and the extent of the manufacturer’s compliance with the applicable GMP standards. See “Regulation of Our Industry—Price Controls.”

As of March 20, 2007, 21 of our 38 products were included in the national Medical Insurance Catalog and were subject to price controls at the national level. In addition, 11 were included in the relevant provincial Medical Insurance Catalog and were subject to price controls within the respective province, municipality or autonomous region. However, PRC Government authorities impose no control over the prices pharmaceutical manufacturers sell their products to their distributors. Nevertheless, the prices at which pharmaceutical manufacturers such as us sell their products to distributors are impacted by the relevant fixed retail price or retail price ceilings.

Since May 1998, the relevant PRC government authorities have ordered price reductions of various pharmaceuticals 22 times. The latest price reductions occurred in January and March 2007 and affected 354 and 278 different pharmaceuticals, respectively. We expect the retail prices of additional pharmaceuticals to be adjusted periodically in the future. Since January 1, 2004, the respective retail prices of our major products Anqi and Zailin and certain of our other products, including Faneng, Nanyuan, Zaike and Zaiqi, were adjusted downward. Such retail price control, especially future downward price adjustments, may negatively affect our revenues and profitability. The following table sets forth the relevant information with respect to historical retail price adjustments of our products since January 1, 2004:

 

Product

 

Brand

 

Dosage Form

 

Date of

Adjustment

  Maximum Retail
Price Before
Adjustment (RMB)
  Maximum Retail
Price After
Adjustment (RMB)

Amoxicillin with clavulanate potassium

  Anqi   Powder injection (0.6g)   June 7, 2004   25.0   21.0
 

Anqi

  Powder injection (1.2g)   June 7, 2004   48.0   38.0
 

Anqi

  Granules (6 packs)   June 7, 2004   28.7   20.0
 

Anqi

  Tablets (12 packs)   June 7, 2004   57.5   48.0
 

Anqi

  Tablets (10 packs)   June 7, 2004   48.0   40.0

Alfacalcidol

  Faneng   Capsules (20 capsules)   January 26, 2007   52.0   38.6
  Faneng   Capsules (30 capsules)   January 26, 2007   78.0   57.0

Herbal Cough Medicine

  Simcere Kechuanning   Liquids (6 vials per box)   March 15, 2007   16.9   16.8

Ribavirin dispersible

  Nanyuan   Dispersible tablets (24 packs)   August 3, 2006   16.2   8.1

Amoxicillin

  Zailin   Powder injection (1.0g)   June 7, 2004   14.0   9.8
 

Zailin

  Dispersible tablets (12 tablets)   June 7, 2004   18.0   14.5
 

Zailin

  Capsules (30 capsules)   June 7, 2004   16.5   11.2
 

Zailin

  Granules (18 packs)   June 7, 2004   18.9   15.1
 

Zailin

  Powder injection (2.0g)   June 21, 2004   27.0   17.2

Azithromycin

  Zaiqi   Granules (9 packs)   October 10, 2005   29.8   18.5
 

Zaiqi

  Granules (6 packs)   October 10, 2005   24.6   12.5

Cefaclor

  Zaike   Dry suspension (9 packs)   June 7, 2004   36.0   25.6
 

Zaike

  Dry suspension (6 packs)   June 7, 2004   24.0   17.3

Two of our branded generic products, Zailin granules and Yingtaiqing capsules, have obtained premium pricing status from the NDRC, which means the respective maximum retail prices of these products are fixed by the NDRC at a level that is generally substantially higher than those of comparable products. We believe that such premium pricing status has historically contributed to our sales of Zailin and Yingtaiqing not only by allowing us to set higher unit prices for these products, but also by ultimately increasing in their sales volume, as hospitals often assign higher points in assessing bids for medicines that have obtained premium pricing status, as such premium pricing status is deemed as recognition of high quality, strong efficacy and widespread market acceptance of the pharmaceutical.

 

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The prices of medicines that are not subject to price controls are determined freely at the discretion of the respective pharmaceutical companies, subject to notification to the provincial pricing authorities. As we sell our products exclusively to pharmaceutical distributors in China, we price our pharmaceuticals that are not subject to price controls based on the prices of competing pharmaceuticals, if any, in the market and our gross margin. For instance, currently Endu is not subject to any price controls.

The Acquisition of Yantai Medgenn

On May 28, 2006, we entered into an agreement to acquire an 80.0% equity interest in Yantai Medgenn, a PRC pharmaceutical company engaged in the research, development, manufacture and sale of an anti-cancer drug under the name Endu. Prior to the completion of the acquisition, we began to market and sell Endu in July 2006 through Jiangsu Simcere as the exclusive distributor for Yantai Medgenn in China. Upon completion of the acquisition on September 30, 2006, we also began to manufacture Endu in China. Under the share purchase agreement, we agreed to pay Yantai Medgenn’s existing shareholders a total purchase price of RMB196.6 million, payable in cash, of which a total of RMB186.8 million has been paid as of December 31, 2006. We will pay the remaining balance of RMB9.8 million no later than June 30, 2008, upon completion of the trial period for certain quality control procedures in relation to Endu, which is procedural in nature. We believe that our current levels of cash and cash flows from operations will be sufficient to meet our remaining payment obligation with respect to the acquisition.

In 2006, our sales of Endu amounted to RMB34.7 million ($4.4 million), including sales made as the exclusive distributor for Yantai Medgenn from July 2006 to September 2006 and sales made since we began to manufacture Endu upon the completion of our acquisition of an 80.0% equity interest in Yantai Medgenn in September 2006. As of March 20, 2007, Endu was used in more than 400 hospitals in China. We expect Endu to have strong growth potential due to the significance of the lung cancer treatment market in China, the lack of competition for the same product and the potential additional indications, such as liver cancer, stomach cancer, colon cancer and breast cancer. We believe our future revenue growth will be partially driven by our sales of Endu.

Revenues

We generate revenue mainly from the sales of our products. Our product revenues represent our total revenues from the sales of our products, less value-added taxes, or VAT. Other revenues represent the refund of a portion of the VAT paid by Nanjing Simcere to the local tax authority as Nanjing Simcere operates in an economic development zone in Jiangsu province. See “—Taxation and Incentives.”

Our products include antibiotics, an anti-stroke medication, anti-inflammatory drugs, an anti-cancer medication and other medicines. We generate a substantial portion of our revenue from sales of our top five branded generic pharmaceutical products, Zailin, Bicun, Yingtaiqing, Anqi, and Biqi, which in aggregate, accounted for 76.1%, 81.6% and 82.6% of our product revenues in 2004, 2005 and 2006, respectively. In 2006, sales of Endu accounted for 3.7% of our product revenues.

 

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The following table sets out a breakdown of our revenues for these five products, and each item expressed as a percentage of our product revenues, for the periods indicated:

 

    For the Year Ended December 31,
    2004   2005   2006
    (in
thousands
of RMB)
  % of
product
revenues
  (in
thousands
of RMB)
  % of
product
revenues
  (in
thousands
of RMB)
  % of
product
revenues

Zailin

  200,444   35.6   228,434   31.0   266,790   28.1

Bicun

  24,101   4.3   139,527   19.0   230,867   24.4

Yingtaiqing

  112,622   20.0   115,536   15.7   136,754   14.4

Anqi

  72,292   12.8   93,642   12.7   76,680   8.1

Biqi

  19,592   3.5   23,693