Simcere Pharmaceutical Group Provides Update on Jiangsu Yanshen
NANJING, China, May 17, 2010 /PRNewswire via COMTEX/ --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 announced that Jiangsu Yanshen Biological Technology Stock Co., Ltd. ("Jiangsu Yanshen") has received official notification from the Changzhou Food and Drug Administration of the financial penalty to be paid in relation to the production of substandard quality human use rabies vaccine.
According to the decision, the Changzhou Food and Drug Administration will impose a fine of RMB25.6 million consisting of penalties and confiscated revenues from previous sales of substandard quality human use rabies vaccine. Jiangsu Yanshen will also bear the cost of patient re-vaccinations up to RMB23 million.
Members of Jiangsu Yanshen's management team and employees directly involved in the production of substandard quality human use rabies vaccine will be prohibited from engaging in the production and marketing of pharmaceutical products for a period of ten years. In addition, a criminal investigation by local law enforcement authorities of Jiangsu Yanshen's aforementioned management team and employees is currently underway.
Simcere entered into an agreement to obtain a controlling stake in Jiangsu Yanshen on October 24, 2009, and subsequently discovered quality control problems relating to the production of Jiangsu Yanshen's human use rabies vaccine. On November 23, 2009, Simcere urged the board of Jiangsu Yanshen to replace its general manager and head of quality assurance and demanded that Jiangsu Yanshen implement a total suspension of production effective on November 30, 2009 to facilitate internal inspection and rectification of its quality control systems. Jiangsu Yanshen has been actively cooperating with relevant authorities on the investigation. To date there have been no reported adverse events related to the vaccine batches in question.
Jiangsu Yanshen operations remain suspended and it is uncertain when it will resume vaccine production.
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 .
SOURCE Simcere Pharmaceutical Group