plasma-based biopharmaceutical products to hospitals and other health care facilities in China. China Biologic's human albumin products are mainly used to increase blood volume and its immunoglobulin
products are used for the treatment and prevention of diseases. China Biologic Products has confirmed that they have received approval from the PRC State Food and Drug Administration (the "SFDA") 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.
"We are pleased that our continued focus on research and development has led us to receive approval from the SFDA for clinical trial of FVIII," said Mr. Chao Ming Zhao, the Company's CEO.
"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."
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