Therapy Areas: AIDS & HIV
Ascletis Pharma Inc submits third HCV drug ASC21 IND with NMPA
3 January 2019 -

Biotechnology company Ascletis Pharma Inc (1672.HK) said on Wednesday that it has filed its investigational new drug application (IND) for its third HCV drug ASC21 successfully with the National Medical Products Administration (NMPA).

According to the company, 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 2018, the company's first HCV drug Ganovo got New Drug Application (NDA) approval and launched successfully and the NDA for its second HCV drug Ravidasvir was also accepted and designated as priority review by NMPA.

The company is committed to treating hepatitis C in greater China with its multiple leading HCV drugs antiviral combinations.