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China Biologic Products, Inc. (CBPO) received SFDA approval to start the production of Cryoprecipitate, a frozen blood product prepared from plasma, and also to begin a clinical trial of Human Prothrombin Complex, a new offering. China Biologic bases its business on plasma-derived biopharmaceuticals. Its human albumin products are used to increase blood volume and its immunoglobulin products treat and prevent diseases.

With the new approval, China Biologic becomes one of four Cryoprecipitate suppliers in China. All of its Cryoprecipitate production will be sold to Green Cross China, following a February 2008 contract. Green Cross China will use Cryoprecipitate to produce Human Coagulation Factor VIII, a coagulation promoter for hemophilia and massive hemorrhaging. Because of the lack of plasma in China over the last year, Human Coagulation Factor VIII has been in short supply.

Cryoprecipitate is extracted from plasma that would otherwise have been discarded, so China Biologic expects Cryoprecipitate will increase its yield per unit volume of plasma. China Biologic projects the contract will generate $430,000 in revenue, and it also plans to continue its own research and development of Human Coagulation Factor VIII.

Human Prothrombin Complex, which was approved for clinical trials, is also a coagulant used to treat congenital bleeding disorders. China Biologic expects to receive initial results from the test within 8 months and SFDA production approval (if the trial is successful) within a year after the trial. That would put the product launch in 2009.

In 2007, China Biologic reported net income of $8.2 million on $32.4 million of revenue. Both numbers were substantially higher than the 2006 report, helped in part by a run-up in prices of all plasma-derived products in China during 2007 caused by the shortage in plasma.

Disclosure: none.

Source: China Biologic Reports Two SFDA Successes