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news.China Biologic Products has received approval from the Chinese State Food and Drug Administration to start the production of Cryoprecipitate, a frozen blood product prepared from plasma and to commence clinical trial of its new product - Human Prothrombin Complex.
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As a result of the approval, China Biologic Products (CBP) is now one of only four Cryoprecipitate suppliers in China. Pursuant to a February 2008 contract, between CBP and Green Cross China, CBP is obligated to sell its Cryoprecipitate to Green Cross China for the use in the production of Human Coagulation Factor VIII, a coagulation treatment for hemophilia and massive hemorrhaging, in short supply due to the recent severe shortage of plasma. The contract is expected to generate over $0.43 million in revenue.
Because Cryoprecipitate is extracted from plasma that would have been discarded previously, management expects that the production of Cryoprecipitate will increase the yield per unit volume of plasma and increase CBP’s profit margin. CBP also plans to continue its own research and development of Human Coagulation Factor VIII.
The company also announced Chinese State Food and Drug Administration (SFDA) approval to commence clinical trial of its new Human Prothrombin Complex, a coagulant used to treat congenital bleeding disorders. Management has commenced preparations for the clinical study and expects to receive results within eight months. If the clinical study is successful, management expects to get SFDA production approval for the product within a year after trial and to launch the product in 2009.