Ascletis’ IND Filing for Its Third HCV Drug ASC21 Accepted by NMPA

Hangzhou and Shaoxing, China, January 3, 2019 -- Ascletis Pharma Inc. (1672.HK), a commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral, cancer and fatty liver diseases, announces today that the investigational new drug application (IND) for its third HCV drug ASC21 was accepted by the National Medical Products Administration (NMPA).

ASC21 is an NS5B nucleotide polymerase inhibitor that has been shown in in vitro studies to have potent, pan-genotypic anti-viral activity and a high genetic barrier to resistance. ASC21, in combination with Ravidasvir, forms a regimen which has the potential to have pan-genotypic activity and to be effective in treating patients with difficult-to-cure genotypes, cirrhosis and HCV/HIV co-infection.

In June 2018, Ganovo®, Ascletis’ first HCV drug got New Drug Application (NDA) approval and launched successfully. On August 1, 2018, Ascletis’ NDA for its second HCV drug Ravidasvir was accepted and designated as priority review in October by NMPA. With three innovative HCV drugs having differentiation in mechanism of actions, Ascletis is committed to treating hepatitis C in greater China with its multiple leading antiviral combinations.