On July 29, 2020, Ascletis' all-oral HCV therapy has been approved for marketing in China by National Medical Products Administration (NMPA). The Company’s all-oral HCV therapy (RDV/DNV Regimen) is Ravidasvir (ASCLEVIR®) in combination with Danoprevir (GANOVO®).
Our second marketed HCV drug , ASCLEVIR® is a best-in-class, NS5A inhibitor with pan-genotypic anti-viral activity, has completed a phase II/III clinical trial. RDV/DNV Regimen (ravidasvir in combination with danoprevir and ribavirin) is an all-oral, interferon-free HCV therapy ，demonstrates a 99% cure rate (SVR12) and a superior safety profile with a short treatment duration of 12 weeks. RDV/DNV Regimen displays a higher genetic barrier to resistance than the approved regimens, Daklinza/Sunvepra. The Phase II/III clincal trial showed RDV/DNV Regimen demomstrated a cure rate of 100% (SVR12) for the patients with baseline NS5A resistance-associated substitutions (RASs).
Advantages of ASCLEVIR®
According to the results of the clincal trials，The RDV/DNV Regimen has the potential to address the limitations of the current primary therapy for CHC with following aspects：
• Best-in-class NS5A inhibitor. RDV/DNV Regimen demonstrated a 99% cure rate (SVR12) in the phase II/III clinical trial in China with 309 HCV genotype 1 patients. The following diagram sets forth the virological response (RVR4, RVR8, EOT and SVR12) from this clinical trial.
• Highly efficacious for patients infected by HCV with baseline NS5A resistance-associated substitutions（RASs）. The RDV/DNV Regimen demonstrated a 100% cure rate (SVR12) for patients with baseline NS5A RASs in the Phase II/III clinical trial. Six patients in Phase II clinical trial (EVEREST) with baseline NS5A RASs and 100% of these patients achieved SVR12. 19% of HCV patients in China with baseline NS5A RASs. Competitor products demonstrated a cure rate of 20% (SVR12) in treating patients infected by HCV genotype 1b with baseline NS5A RASs. The following diagrams set forth the SVR12 of patients with baseline NS5A RASs in Phase II/III clinical trial and Phase II clinical trial (EVEREST) of RDV/DNV Regimen.
• Efficacious for hard-to-cure genotypes. Phase II/III clinical trial of RDV/SOF Regimen demonstrated a 99% cure rate (SVR12) in genotype 1a patients and 97% cure rate (SVR12) in genotype 3 patients. The following diagram sets forth the SVR12 of patients infected with hard-to-cure HCV genotypes in a phase II/III clinical trial for RDV/SOF Regimen abroad.
• Efficacious in CHC patients with cirrhotic. Phase II/III clinical trial of RDV/SOF Regimen abroad，demonstrated a 96% cure rate (SVR12) in CHC patients with cirrhotic . The following diagram sets forth the SVR12 for these patients in phase II/III clinical trial abroad.
• Efficacious for HCV/HIV co-infected patients. Phase II/III clinical trial of RDV/SOF Regimen abroad，demonstrated a 97% cure rate (SVR12) in HCV/HIV co-infected patients. The following diagram sets forth the SVR12 for HCV/HIV co-infected patients in a phase II/III clinical trial abroad.
• Pan-genotypic anti-viral activity against genotypes 1 to 6. Ravidasvir showed the potent anti-viral activity against HCV genotopyes 1-6 in vitro. Two phase II/III clinical trials of RDV/SOF Regimen abroad， demonstrated an overall 97% cure rate (SVR12) in genotypes 1, 2, 3 and 6 and 95% cure rate (SVR12) in genotype 4. The following diagram sets forth the SVR12 for the HCV genotypes indicated below in these two phase II/III clinical trials.
• Superior safety and tolerability profile. Phase II/III clinical trial have shown the RDV/DNV Regimen to be safe and well-tolerated. There were no treatment-related serious adverse events. Except for anemia and hyperuricemia, the occurrence of adverse event was similar between the RDV/DNV treatment group and placebo group. The higher occurrence rate of anemia in the RDV/DNV treatment group may be related to ribavirin.