China Biologic Products, Inc. a leading fully integrated plasma-based biopharmaceutical company in China, announced that its indirectly owned subsidiary, Shandong Taibang Biological Products Co., Ltd. has received a manufacturing approval certificate from the China State Food and Drug Administration (“SFDA”) for Human Coagulation Factor VIII (“FVIII”). With this certificate, the only approval remaining for Taibang’s commercial production of FVIII is the SFDA’s good manufacturing practice (“GMP”) certification of the FVIII production line itself.
Taibang began research for FVIII in 2007 and successfully developed the technology in 2008. The Company conducted clinical trials from 2009 to 2010. In June 2010, the Company submitted required materials to Center for Drug Evaluation for approval to start manufacturing and passed on-site products verification in January 2011. The Company received official manufacturing approval certificate on June 21, 2012.