China Biopharmaceuticals Holding Inc., a leading Chinese pharmaceutical company focused on the development, manufacturing and distribution of innovative drugs in China, has completed all required clinical trials for one of its new drugs, Nafamostate Mesilate and is waiting for final manufacturing and marketing approval from the State Food and Drug Administration of China (SFDA). The trials were conducted in ten hospitals throughout China.

The trial results will be sent to the SFDA for market and manufacturing approval, which has expected, to be granted by the middle of 2007. Nafamostate Mesilate is a kallikrein inhibitor whose clinical indications include the treatment of Disseminated Intravascular Coagulation (DIC) and Acute Pancreatitis, as well as usage as an anticoagulant in heart operations.

Currently, there are 1.4 million people suffering with DIC in China and CHBP is the only company approved for clinical trials of this drug in China. If granted production approval, in accordance with Chinese SFDA current policies, CHBP will have at least a 4-year manufacturing exclusive for this drug in China.

An Lufan, CHBP President and COO, stated, "Having successfully completed all required Nafamostate Mesilate clinical trials is a key step towards final approval and the subsequent manufacturing and marketing of this drug. This is only one of many new drug initiatives of our company. The successful completion of the required clinical trials demonstrates CHBP's leading R&D capabilities, robust product pipeline and CHBP's R&D team's ability to successfully navigate the drug testing and approval process. If approved by the SFDA, our drug will help hundreds of thousands of patients in China."

Source:佚名