Ascletis gains approval from Chinese FDA for hepatitis C treatment

Partner of STA Pharmaceutical, Ascletis, has been granted approval by the Chinese Food and Drug Administration (CFDA) for its Category 1 new drug, Ganovo (also known as Danoprevir or ASC08) to treat viral hepatitis C.

With this announcement, STA Pharmaceuticals — a subsidiary of WuXi AppTec — has become the first CDMO in China to support the launch of an innovative drug using the Marketing Authorisation Holder (MAH) pilot programme.

Ganovo is a direct-acting anti-viral agent (DAA) that has been developed by a domestic company and selected as a National Science and Technology Major Project for ‘Innovative Drug Development’. WuXi STA supported the process optimisation and process validation of Ganovo active pharmaceutical ingredient (API), as well as the NDA submission and approval of the drug.

“The successful development of Ganovo fulfilled our commitment to deliver affordable innovative drugs for the Chinese patients,” said Jinzi J. Wu, PhD, 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.”

“Congratulations to our partner Ascletis for reaching this milestone. The strong support received from the Chinese government for new drugs and the successful implementation of ‘MAH’ pilot was integral to reaching this milestone. We now look forward to enabling more partners to launch their innovative medicines both in China and internationally for benefit of patients around the world,” added Dr Minzhang Chen, CEO of WuXi STA.