China SFDA approves Taibang's clinical trials for human fibrinogen

Mar 23 2012

China Biologic Products, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, today announced that its indirectly owned subsidiary, Shandong Taibang Biological Products Co., Ltd. ("Taibang"), recently received approval from the China State Food and Drug Administration ("SFDA") to begin clinical trials for its human fibrinogen to be used to treat congenital fibrinogen deficiency and acquired fibrinogen deficiency.Under Chinese regulations, the Company can begin with the phase III clinical trials, which includes the efficacy study, since phases I and II are not required for this product.

Mr. Chao Ming (Colin) Zhao, China Biologic's President & Chief Executive Officer, said, "We are very pleased to receive the SFDA's approval to enter clinical trials for our human fibrinogen product. Our human fibrinogen is made using our internally developed new manufacturing process, which improves product quality, compared with currently available products in the Chinese market. The new process also increases plasma utilization and production efficiency. We plan to secure a patent for our manufacturing invention. We believe this new product also will advance our plasma protein development pipeline. The phase III clinical trials are expected to last about two years, after which we will begin commercial production and sales, assuming the clinical trials prove that the product provides the safe and effective treatments we expect."

The Company began pre-clinical research in 2008 for its human fibrinogen, including its production process development and pharmaceutical research. In 2009, it completed pre-clinical inactivated virus research and validation work related to the product's development. In 2010, the Company conducted the pilot study for human fibrinogen and in mid-2010 submitted its application to the SFDA for approval to start human clinical trials for its human fibrinogen.