Breaking News, Collaborations & Alliances

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

Is first CDMO to support the approval of an innovative drug in China through the MAH pilot program

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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...

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