Simcere Pharmaceutical Group Provides Update on Jiangsu Yanshen

Simcere Pharmaceutical Group Provides Update on Jiangsu Yanshen
NANJING, China, Dec. 3 /PRNewswire-Asia/ -- Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE: SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported that China's State Food and Drug Administration ("SFDA") has initiated a comprehensive investigation into quality issues regarding human use rabies vaccine (vero cell) manufactured by Simcere's subsidiary Jiangsu Yanshen Biological Technology Stock Co., Ltd. ("Jiangsu Yanshen").

On November 23, 2009, Simcere urged the board of Jiangsu Yanshen to replace its general manager and head of quality assurance. Jiangsu Yanshen subsequently decided to implement a total suspension of production in order to improve its quality control systems effective on November 30, 2009.

The SFDA issued a public notice on December 3, 2009 announcing the initiation of a comprehensive investigation into quality issues regarding human use rabies vaccine manufactured by two companies including Jiangsu Yanshen. The SFDA has assigned investigation teams to oversee the provincial administrations' inquiry into the matter and has established a file on Jiangsu Yanshen. Four batches of the human use rabies vaccine manufactured by Jiangsu Yanshen between July and October 2008 have been found to have quality problems. The SFDA has ordered Jiangsu Yanshen to halt marketing and production of all products including human use rabies vaccine and has organized experts to provide an assessment of risks presented by the problem vaccine. According to the SFDA announcement, patients who received the vaccine in question may receive medical consultations with their original inoculation hospitals. The resumption of production and sales at Jiangsu Yanshen as well as potential penalties will be subject to the findings of the investigation.

Mr. Jinsheng Ren, Chairman and Chief Executive Officer of Simcere Pharmaceutical Group, commented: "As a responsible company which always prioritizes the safety of our patients and customers, Simcere has urged Jiangsu Yanshen to actively cooperate with the SFDA's investigation. We will keep the market updated of any further developments in a timely manner."

Safe Harbor Statement

This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "project," "predict," "should" and "will" and similar expressions. In particular, the quotations from management in this press release and the section under "Financial Outlook" contain forward-looking statements. These forward looking statements are based upon management's current views and expectations with respect to future events and are not a guarantee of future performance. Furthermore, these statements are, by their nature, subject to a number of risks and uncertainties that could cause actual performance and results to differ materially from those discussed in the forward-looking statements as a result of a number of factors. Further information regarding these and other risks is included in Simcere's filings with the U.S. Securities and Exchange Commission at http://www.sec.gov . Simcere does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

About Simcere Pharmaceutical Group

Simcere Pharmaceutical Group (NYSE:SCR, Simcere) is a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China. In recent years, Simcere has been focusing its strategy on the development of innovative pharmaceuticals and first-to-market generics, and has introduced an innovative anti-cancer medication Endu, a first-to-market medication Sinofuan, and first-to-market generics such as Bicun and Anxin. Simcere manufactures and sells antibiotics, anti-cancer medication stroke management medication and biopharmaceutical drugs such as vaccines. Simcere concentrates its 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, strokes, orthopaedics and infectious diseases. For more information about Simcere Pharmaceutical Group, please visit http://www.simcere.com .

    For more information, please contact:

    Investor and Media Contacts:
     Email: [email protected]

    In Nanjing:
     Frank Zhao
     Chief Financial Officer
     Simcere Pharmaceutical Group
     Tel: +86-25-8556-6666 x8818

    In the United States:
     Kate Tellier
     Brunswick Group
     Tel: +1-212-333-3810

    In Beijing:
     Ruirui Jiang
     Brunswick Group
     Tel: +86-10-6566-2256

    In Hong Kong:
     Joseph Lo Chi-Lun
     Brunswick Group
     Tel: +852-3512-5000

SOURCE Simcere Pharmaceutical Group

Investor and Media Contacts: [email protected]; In Nanjing: Frank Zhao, Chief Financial Officer, Simcere Pharmaceutical Group, +86-25-8556-6666 x8818; In the United States: Kate Tellier, Brunswick Group, +1-212-333-3810; In Beijing: Ruirui Jiang, Brunswick Group, +86-10-6566-2256; In Hong Kong: Joseph Lo Chi-Lun, Brunswick Group, +852-3512-5000

Suggested Articles

Cedrik Britten, M.D., becomes the biotech’s new chief medical officer to help run its adoptive cell therapy and TCR bispecifics platform.

Five Prime Therapeutics’ clinical development lead is hoping for a more stable time at new employer Spectrum Pharma.

The update comes as Gilead closes in on a FDA approval that will position it to compete with JAK inhibitors sold by AbbVie, Eli Lilly and Pfizer.