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."
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