Dragon Pharmaceuticals Inc. is pleased to announce that Nanjing Huaxin Biotech Co., Ltd. has acquired co-development rights to a Pichia yeast culture system for the production of TPO from Kelong Industrial Co., Ltd, a Chinese company.
Dragon holds a 75% equity interest in Nanjing Huaxin. TPO is a blood growth factor that stimulates the production of platelets that are required in the process of haemostasis (i.e. blood coagulation), which is a critical process in blood clotting and wound healing.
Amgen and Genentech are developing TPO in North America, with Amgen using an E. coli bacterial system (and then modifying the protein for human use using PEG technology) and Genentech using a CHO cell culture. The Genentech technology was sold to Pharmacia-Upjohn, where it has entered Phase III clinical trials.
Huaxin has developed a Pichia yeast system which is expected to have a higher yield than the mammalian CHO cell line. Pre-clinical and animal studies that are required in China for permission to start human clinical trials have been completed. Since a yeast culture system for TPO has not been utilized anywhere in the world, Dragon’s TPO could be categorized as a Class I new drug in China by the State Bureau of Drug Administration. If a new drug license is granted, Dragon will enjoy exclusive marketing rights on TPO produced from a yeast culture system for 15 years in China. The Company plans to utilize its existing production facilities at Nanjing Huaxin and anticipates that its TPO product could be ready for marketing within two years.
Dragon Pharmaceuticals, the largest EPO producer in China, is currently a leading biotech company focusing on the research, development, production, and marketing of biodrugs throughout China.