Second Ascletis HCV therapy gets expedited CFDA review

Ascletis BioScience Co. Ltd. (Hangzhou, China) said HCV candidate danoprevir (ASC08) has been accepted for expedited review by China FDA. The company expects the candidate to become the first domestically researched small molecule antiviral marketed in China.

In April 2016, CFDA selected the company's ravidasvir (ASC16) for expedited review via the country's new approval pathway. Ascletis has studied ravidasvir and danoprevir in combination. Ravidasvir is a second-generation HCV NS5A protein inhibitor, while danoprevir is a HCV NS3/4A protease complex inhibitor...