China Biologic Products (CBPO) Unit Receives China FDA Approval to Begin Human Coagulation Factor IX Trial
- Oil steady around $50 on doubts over OPEC output cuts
- lululemon athletica (LULU) Tops Q3 EPS by 4c; Adj.-Comps Outpaced Views
- Costco Wholesale (COST) Tops Q1 EPS by 5c; Comps Up 1%, 2% Ex-Gas
- Universal Health (UHS) Disputes and Denies Conclusions in BuzzFeed Article
- Perrigo (PRGO) to Restructure BCH Omega Pharma Belgium Business; Will Terminate EuroGenerics Agreement
Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a FREE trial here.
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."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Adams Resources (AE) Appoints New CFO
- Horizon Pharma (HZNP) Announces ACTIMMUNE Phase 3 in FA Missed Primary Endpoint
- Qualcomm (QCOM), Microsoft (MSFT) Enter Collaboration for Windows 10 on Snapdragon-Powered Mobile Devices
Create E-mail Alert Related CategoriesCorporate News, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!