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 Roche (SIX:ROG; OTCQX:RHHBY) in 2013.

Ascletis is aiming to beat a host of competitors to the huge HCV market in China. In April, CFDA selected the company's ravidasvir (ASC16), a second-generation HCV NS5A protein inhibitor, for expedited review via a new approval pathway. The agency also selected HCV compounds from Gilead Sciences Inc. (NASDAQ:GILD); Bristol-Myers Squibb Co. (NYSE:BMY); AbbVie Inc. (NYSE:ABBV); Johnson & Johnson (NYSE:JNJ); TaiGen Biopharmaceuticals Holdings Ltd. (PTEx:4157); and Beijing Kawin Technology Share-Holding Co. Ltd. (Beijing, China) (see BioCentury Extra, April 25). ...