China Biologic Receives CFDA Clinical Trial Approval for Human Antithrombin III

China Biologic Products, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, announced that Shandong Taibang Biological Products Co. Ltd., the company’s majority-owned subsidiary, recently obtained approval from the China Food and Drug Administration (CFDA) to begin human clinical trials on its Human Antithrombin III (ATIII) product.

ATIII is intended to treat hereditary and acquired ATIII deficiency in connection with surgical or obstetrical procedures, and to treat thromboembolism. No manufacturer in China currently offers plasma-derived ATIII product. China Biologic expects to commence clinical trials for the ATIII product in 2017 and complete the trials in two years or longer.

Mr. David (Xiaoying) Gao, Chairman and Chief Executive Officer of China Biologic, commented, “We are pleased to obtain approval by the CFDA to conduct clinical trials for our ATIII product. This approval comes shortly after we received clinical trial approval for our Human Coagulation FIX product, which demonstrates our ongoing research and development efforts and commitment to serving the broader needs of coagulation-deficient patients. In addition to its known indications, we believe the ATIII product also has broader treatment uses, for which we intend to conduct further research. We believe this product will further improve our plasma fractionation utilization and also contribute to our future financial performance.”

To view the full press release, click here.

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!