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 Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China); Harvoni ledipasvir/ sofosbuvir and Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD); Daklinza daclatasvir and Sunvepra asunaprevir from Bristol-Myers Squibb Co. (NYSE:BMY); Technivie ombitasvir/paritaprevir/ritonavir and Exviera dasabuvir from AbbVie Inc. (NYSE:ABBV); Olysio simeprevir from Johnson & Johnson (NYSE:JNJ); furaprevir ( TG-2349) from Taiwan-based TaiGen Biopharmaceuticals Holdings Ltd. (PTEx:4157); and KW-136 from Beijing Kawin Technology Share-Holding Co. Ltd. (Beijing, China). ...