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news.China Biologic Products, a plasma-based pharmaceutical company, has received approval from the People's Republic of China State Food and Drug Administration to commence clinical trial of its new human coagulation Factor VIII product, a coagulation treatment for hemophilia and mass hemorrhaging.
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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 human coagulation factor VIII (FVIII).
With its own supply of cryoprecipitate and its continued R&D of FVIII, the company has obtained approval to commence clinical trial for 200IU and 300IU 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 State Food and Drug Administration’s (SFDA) approval for production to launch the product at the beginning of 2010.
Chao Zhao, CEO of China Biologic, 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.”