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Ganovo®

We expect to launch Ganovo®, the first breakthrough drug for HCV developed by a domestic company in China by the third quarter of 2018. Ganovo® is an NS3/4A protease inhibitor, which, when administered in combination with pegylated interferon and ribavirin (Ganovo Regimen), demonstrates a 97% cure rate (SVR12) and superior safety profile with a short treatment duration of 12 weeks. The current primary regimen of pegylated interferon and ribavirin in China has a cure rate of approximately 60% (SVR24) with a treatment duration of 48 to 72 weeks.

 

Ravidavir

Our second HCV drug candidate, ravidasvir, which we believe is a best-in-class, NS5A protein inhibitor with pan-genotypic anti-viral activity, has completed a phase II/III clinical trial. We expect to file an NDA for ravidasvir in the third quarter of 2018. Our RDV/DNV Regimen (ravidasvir in combination with Ganovo and ribavirin) is an all-oral, interferon-free HCV therapy and demonstrates a 99% cure rate (SVR12) and a superior safety profile with a short treatment duration of 12 weeks. The current primary regimen in China has a cure rate of approximately 60% (SVR24) with a treatment duration of 48 to 72 weeks. Our RDV/DNV Regimen displays a higher genetic barrier to resistance than the approved regimens, Daklinza/Sunvepra. In patients with baseline NS5A resistance mutations, our phase II/III clinical trial showed that our RDV/DNV Regimen demonstrates a cure rate of 100% (SVR12).

 

ASC21

An IND-ready nucleotide inhibitor targeting HCV NS5B. Pre-clinical studies have shown ASC21 to be potent, pan-genotypic with a high genetic barrier to resistance. ASC21, in combination with ravidasvir, forms a regimen which has the potential to be pan-genotypic and to treat difficult-to-cure, cirrhotic and HCV/HIV co-infected patients.