STA Pharmaceutical (WuXi STA) announced its partner, Ascletis has received approval from China Food and Drug Administration (CFDA) of its Category 1 new drug, Ganovo (also known as Danoprevir or ASC08), to treat viral hepatitis C.
The collaboration between WuXi STA and Ascletis began in 2012, and the approval of Ganovo marks a milestone in the history of the “MAH” policy in China. WuXi STA is now the first Contract Development and Manufacturing Organization (CDMO) in China to support the launch of an innovative drug using the Marketing Authorization Holder (MAH) pilot program.
Ganovo is the first Direct-acting Anti-viral Agent (DAA) developed by a domestic company in China and has been selected as a National Science and Technology Major Project for “Innovative Drug Development”.
WuXi STA supported the process optimization and process validation of Ganovo Active Pharmaceutical Ingredient (API), as well as the Ganovo NDA submission and approval via its process development and manufacturing technology platform, and global standard quality systems.
In December 2017, WuXi STA’s Jinshan API manufacturing site successfully passed the pre-approval inspection by CFDA as part of the Ganovo NDA application process.
"The successful development of Ganovo fulfilled our commitment to deliver affordable innovative drugs for the Chinese patients." said Jinzi J. Wu, Ph.D., Ascletis' founder, President and CEO. "We sincerely appreciate the dedicated support from WuXi STA over the past six years, which was crucial to the approval of Ganovo.”