China Biologic's human fibrinogen production cleared by CFDA

China Biologic Products (Nasdaq: CBPO) says its subsidiary  Shandong Taibang Biological has received approval from the China Food and Drug Administration (CFDA) for commercial manufacturing of human fibrinogen at its facility in Shandong Province.

The company expects that Shandong Taibang will receive the good manufacturing practice certificate issued by CFDA within a month and commence commercial production immediately thereafter, and expects the first batch of products to be released to market by the end of 2017.

China Biologic began pre-clinical research for Fibrinogen in 2008 and received approval to begin Phase III clinical trials for Fibrinogen in 2012. The CFDA completed on-site inspection of Shandong Taibang's production facility in late 2016 and completed on-site clinical data inspection at various hospitals that carried out the phase III clinical trials during the second quarter of 2017.

David (Xiaoying) Gao, chairman and chief executive of China Biologic, commented: "We are very excited to receive this long-awaited approval from the CFDA to launch our fibrinogen production. Fibrinogen products have been in short supply in China over the last several years with prices experiencing significant increases since the NDRC lifted price-ceiling controls in early 2015.”