Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China) said China's State Drug Administration approved an NDA for Ganovo danoprevir to treat HCV. The company intends to launch the product next quarter, according to its website. Ascletis said the drug is the first domestically developed direct-acting antiviral agent.
Last month, Ascletis became the first biotech to apply for an IPO on the new biotech chapter of the Hong Kong Exchanges and Clearing Ltd. (HKEX) (see BioCentury, May 11).
Ascletis gained rights to Ganovo, an HCV NS3/4A protease inhibitor, from Roche (SIX:ROG; OTCQX:RHHBY) in 2013 (see BioCentury Extra, April 15, 2013).