WuXi STA: China approves first CMO-made new drug
The China Food and Drug Administration (CFDA) has approved Ascletis’ new drug application (NDA) for viral hepatitis C treatment Ganovo.
Made by contract development and manufacturing organisation (CDMO) WuXi STA – a subsidiary of WuXi AppTec – Ganovo is the first ‘new drug’ to receive regulatory approval in China since the country adopted its Marketing Authorisation Holder (MAH) pilot programme.
The MAH programme refers to China’s changing contract manufacturing organisation (CMO) policies. As of May 2016, China’s State Council has opened the market to GMP-compliant third party manufactures in some provinces to make pharmaceutical drug products for customers.
Anti-viral agent Ganovo – also known as Danoprevir or ASC08 – is the product of a five-year collaboration between Ascletis and WuXi STA.
According to the CDMO, WuXi STA “supported the process optimisation and process validation of Ganovo active pharmaceutical ingredient (API) as well as Ganovo’s NDA submission and approval.”
The active pharmaceutical ingredient (API) was manufactured at WuXi STA’s Jinshan site, and Ganovo is only approved in China, we were told.
In a statement released earlier today, WuXi STA CEO Minzhang Chen said: “The strong support received from the Chinese government for new drugs and the successful implementation of ‘MAH’ pilot was integral to reaching this milestone.”