China Biologic Receives SFDA Approval For Clinical Trials Of FVIII

China Biologic Products, a company producing plasma-based pharmaceuticals, has received approval from the Chinese State Food and Drug Administration to commence clinical trials of its new Human Coagulation Factor VIII product — a coagulation treatment for hemophilia and mass hemorrhaging.

As one of four suppliers of Cryoprecipitate in China, China Biologic has been engaged in a contract to supply Cryoprecipitate to Green Cross China for use in the production of FVIII. With its own supply of Cryoprecipitate and its continued research and development of FVIII, the Company has obtained approval to commence clinical trials of FVIII at 200 IU and 300 IU per dose.

China Biologic has commenced preparations for the clinical study and expects to receive results by mid-2009. If the clinical study is successful, the company's management expects to get SFDA's approval to launch the product at the beginning of 2010.

You May Also Like

Leave a Reply

Your email address will not be published. Required fields are marked *