AsianScientist (Mar. 23, 2012) – China Biologic Products, Inc., announced this week that its indirectly owned subsidiary, Shandong Taibang Biological Products Co., Ltd., has received approval from the China State Food and Drug Administration to begin clinical trials for human fibrinogen as a treatment for congenital fibrinogen deficiency and acquired fibrinogen deficiency.
The company’s human fibrinogen product that is entering its clinical trials is a heat-treated, lyophilized fibrinogen powder made using plasma from healthy humans.
Human fibrinogen is indicated for the treatment of (a) congenital fibrinogen reduction or deficiency and (b) acquired fibrinogen deficiency associated with serious liver damage, cirrhosis, disseminated intravascular coagulation, or coagulation disorder resulting from the lack of fibrinogen related to postpartum hemorrhage, major surgery, trauma, or acute bleeding.
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.
“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,” said Mr. Chao Ming (Colin) Zhao, China Biologic’s President & CEO.
According to Zhao, the company plans to secure a patent for their manufacturing invention. The Phase III clinical trials are expected to last about two years, Zhao said, after which the company will begin commercial production and sales pending trial results.
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.
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Source: China Biologic Products, Inc.
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