23:13 , Mar 3, 2017 |  BC Extra  |  Company News

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...
00:10 , Dec 30, 2016 |  BC Extra  |  Company News

China accepts NDA for Ascletis' HCV candidate

Ascletis Pharmaceuticals Co. Ltd. (Shaoxing, China) said China FDA accepted for review an NDA for danoprevir ( ASC08 ) to treat HCV infection. The company obtained Chinese rights to the HCV NS3/4A protease inhibitor from...
02:43 , Apr 26, 2016 |  BC Extra  |  Politics & Policy

CFDA names HCV drugs in expedited pathway

China FDA said HCV treatments from seven domestic and multinational companies have been selected for expedited review via a new pathway, L.E.K. Consulting's Helen Chen told BioCentury. The therapies include ravidasvir ( ASC16 ) from...