CFDA Approves Drug Developed with CDMO Support

June 19, 2018

WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.

STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, announced on June 14, 2018 that its partner, Ascletis, has received approval from China Food and Drug Administration (CFDA) for its Category 1 drug, Ganovo (Danoprevir or ASC08), to treat viral hepatitis C. WuXi STA provided process optimization and process validation support for the active pharmaceutical ingredient (API), as well as new drug application (NDA) submission and approval.

The approval of Ganovo marks the first time a contract development and manufacturing organization (CDMO) in China supported the launch of an innovative drug using the Marketing Authorization Holder (MAH) pilot program, the company reported in a statement.

In December 2017, WuXi STA’s Jinshan API manufacturing site passed the pre-approval inspection by CFDA as part of the Ganovo NDA application process.

Source: WuXi STA