Product introduction anticipated to address unmet medical needs in pain management.
The China State Food & Drug Administration (SFDA) granted China Aoxing Pharmaceutical (CAXG) designated manufacturer status to produce Tilidine tablets and capsules.
Tilidine is a prodrug, which, following oral administration, is converted to the active analgesic metabolite nortilidine. Tilidine is indicated for the relief of acute, moderate to severe, and chronic cancer-related pain. Currently Tilidine is not available in China and will be introduced by CAXG to the Chinese market.
“We are very pleased with the SFDA’s decision to designate our company as the only drug manufacturer for this highly regulated cancer pain medicine in China. We expect to launch this important and needed cancer-pain medicine through CAXG’s integrated 500 person sales force in 2008,” says Zhenjiang Yue, CEO of CAXG.
Under SFDA regulations, China Aoxing will have five-year exclusivity in the Chinese market.