China Biologic Gets CFDA Trial Approval For Human Coagulation Factor IX

(RTTNews) - China Biologic Products Inc. (CBPO) said that Shandong Taibang Biological Products Co. Ltd., the Company's majority-owned subsidiary, recently obtained approval from the China Food and Drug Administration or "CFDA" to begin human clinical trials on its Human Coagulation Factor IX or "FIX" product.

Human Coagulation FIX is intended for use in the therapy of prevention and control of bleeding in patients who suffer from inherited FIX deficiency, known as hemophilia B, or acquired clotting FIX deficiency. The World Federation of Hemophilia estimates that about 80,000 to 120,000 individuals in China are afflicted with hemophilia and registered hemophilia B patients represent a small portion of hemophilia patients due to the poor levels of diagnosis in China. Currently, there is no plasma-derived purified FIX product in China.

China Biologic initiated its FIX research program in 2014 and its clinical trial application for FIX was officially accepted by the CFDA in December 2015. China Biologic plans to commence clinical trials for the FIX product in 2017 and expects to complete these trials by 2018.