Singapore, Sept 18, 2008: China Biologic Products, a plasma-based pharmaceutical company in China has received the Chinese State Food and Drug Administration approval to commence clinical trial of its new Human Coagulation Factor VIII product (FVIII), 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 trial for 200 IU and 300 IU per dose of FVIII.
China Biologic has commenced preparations for the clinical study and expects to receive results by mid-2009. If the clinical study is successful, management expects to get SFDA's approval for production to launch the product at the beginning of 2010.
Mr. Chao Ming Zhao, CEO, China Biologic Products said, "The approval represents a significant milestone on diversifying our product portfolio. In addition, we believe our ability to produce Cryoprecipitate from clinical extra plasma - plasma that would have been discarded previously - will yield a higher gross profit margin in the production of FVIII." |