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New hep C drug secures China FDA approval
August 2018
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SHANGHAI—The China Food and Drug Administration recently granted approval to Ascletis for the category 1 new drug Ganovo (also known as Danoprevir or ASC08) for the treatment of viral hepatitis C, as announced by STA Pharmaceutical Co. Ltd. (WuXi STA), partner of Ascletis and subsidiary of WuXi AppTec. WuXi STA and Ascletis first struck up a collaboration in 2012, and with this approval, WuXi STA is the first contract development and manufacturing organization in China to support the launch of a new drug under the Marketing Authorization Holder pilot program.
 
“The successful development of Ganovo fulfilled our commitment to deliver affordable innovative drugs for the Chinese patients,” said Dr. Jinzi J. Wu, 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.”

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