China Biologic, Inc. (CBPO) Announces Receipt of GMP Certificate for Human Coagulation Factor VIII

Yesterday, China Biologic Products announced that Shandong Taibang Biological Products Co. Ltd., its indirectly owned subsidiary, has received good manufacturing practice (GMP) certification from the China State Food and Drug Administration (SFDA) for Human Coagulation Factor VIII (FVIII). The SFDA previously granted manufacturing approval to Taibang for FVIII in June 2012. Now possessing both manufacturing approval and the GMP certificate, Taibang plans to immediately begin commercially manufacturing FVIII products.

FVIII is widely used for the treatment of hemophilia A. There is a substantial hemophilia patient population in China – estimated at between 60,000-100,000 persons afflicted and around 10,000 patients registered – who require lifelong treatment with medication. Only three domestic companies currently produce plasma-based FVIII products. In order to mitigate the situation of China’s significant under-supply of coagulation products, Taibang is in the process of building additional manufacturing line capacity for FVIII.

Executives at Taibang are encouraged by the receipt of both manufacturing approval and the GMP certificate, and with the addition of coagulation factor products, the company is pleased to now offer all three major categories of blood products to the market in China. Supplying FVIII will substantially improve the market penetration of the company’s plasma-based offering and further strengthen Taibang’s competitive position as one of the top plasma-based biopharmaceutical companies in China.

A leading fully integrated plasma-based biopharmaceutical company in China, China Biologic offers products that are used as critical therapies during medical emergencies and for the prevention and treatment of life-threatening diseases and immune-deficiency related diseases. Headquartered in Beijing, the company manufactures more than 20 plasma-based products through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co. Ltd. and Guiyang Dalin Biologic Technologies Co. Ltd. China Biologic also has an equity investment in Xi’an Huitian Blood Products Co. Ltd. China Biologic sells its products to hospitals and other healthcare facilities in China.

For more information, visit the company’s Web site at www.chinabiologic.com

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