China Biologic Products (CBPO) Unit Receives China FDA Approval to Begin Human Coagulation Factor IX Trial
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China Biologic Products, Inc. (Nasdaq: CBPO) announced that Shandong Taibang Biological Products Co. Ltd., the Company's majority-owned subsidiary, recently obtained approval from the China Food and Drug Administration (the "CFDA") to begin human clinical trials on its Human Coagulation Factor IX ("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 approximately 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.
Mr. David (Xiaoying) Gao, Chairman and Chief Executive Officer of China Biologic, commented, "We are proud to become the first domestic Chinese plasma company to introduce the effective treatment of FIX deficiency to patients who are routinely treated with fresh frozen plasma when other treatments are unavailable or unaffordable. Once we commercially launch the FIX product, we expect that our prothrombin complex concentrate product, which is used to treat hemophilia B when affordable FIX product is unavailable, will play a more critical role in the under-served market for general blood clotting treatments in China, including liver disease and surgical bleeding. Our FIX product represents the fourth coagulation factor product from China Biologic. We continue our focus on serving the broader needs of coagulation-deficient hemophilia patients and to further improve plasma fractionation utilization, which we believe will also contribute to our future financial performance."
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