WuXi STA Enables Ascletis to Receive NDA Approval from China FDA for Ganovo

STA Pharmaceutical, a subsidiary of WuXi AppTec, said that its partner, Ascletis has received approval from China Food and Drug Administration (CFDA) for 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 critical 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's 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. As a pioneer of MAH, WuXi STA is helping other drug development partners in China, including Ascletis, to optimize their manufacturing processes, significantly reduce commercial production costs, mitigate business risk, and improve operational efficiency.

"The successful development of Ganovo fulfilled our commitment to deliver affordable innovative drugs for the Chinese patients," said Jinzi J. Wu, founder, president and chief executive officer, Ascletis. "We sincerely appreciate the dedicated support from WuXi STA over the past six years, which was crucial to the approval of Ganovo."

Dr. Minzhang Chen, chief executive officer, WuXi STA, said, "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."