Hangzhou and Shaoxing, China, January 2, 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 Ganovo® (Danoprevir) has been enrolled in the Basic Medical Insurance of Chengdu, Sichuan Province. This is another important milestone for patient access to Ganovo® after its recent enrollment in Tianjin Basic Medical Insurance Program under capped-reimbursement per patient pilot program and Shaoxing government funding subsidy program.
Ganovo® is the first direct-acting antiviral agent (DAA) developed and commercialized by a domestic company in China. Ganovo® inhibits the hepatitis C virus (HCV) NS3/4A protease that is critical to HCV replication. In the phase III clinical trial conducted in Mainland China, Ganovo regimen (Ganovo® in combination with PEGylated interferon and ribavirin) demonstrated a cure rate of 97% (SVR12) in HCV genotype 1 non-cirrhotic patients with a 12-week treatment duration. Ganovo®, in combination with Ravidasvir, an NDA accepted HCV NS5A inhibitor, and ribavirin, forms an all-oral, interferon-free HCV therapy (RDV/DNV Regimen), which offers a cure rate of 99% (SVR12) in the phase II/III clinical trial of HCV genotype 1 non-cirrhotic patients with 12-week treatment duration. In the same phase II/III clinical trial, RDV/DNV Regimen demonstrated a cure rate of 100% (SVR12) for patients with baseline NS5A resistance mutations.
Jinzi J. Wu, Ph.D., Ascletis' Founder, Chairman and CEO commented, "I’m very glad that Ganovo® has gained yet another endorsement from the medical insurance authorities and is well-recognized in the clinical community for its efficacy and safety. We anticipate Ganovo® will gain additional reimbursement access and further benefit hepatitis C patients in China."