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China, Taiwan accept Ascletis' CTAs for HCV therapies
June 25, 2015 12:14 AM UTC
Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China) said the China Food and Drug Administration (CFDA) and Taiwan Food and Drug Administration (TFDA) accepted clinical trial applications (CTAs) to run trials of danoprevir ( ASC08) and ASC16 ( PPI-668) to treat HCV. Ascletis said it is the first Chinese company to submit CTAs in China for an interferon-free HCV regimen.
The company licensed Chinese rights to danoprevir, a second-generation HCV NS3/4A protease inhibitor, from Roche (SIX:ROG; OTCQX:RHHBY) in 2013 after Roche discontinued development. ...