Hangzhou and Shaoxing, China, April 15, 2019 -- Ascletis Pharma Inc. (Ascletis, 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 according to the official notifications from Zhejiang Provincial Medical Insurance Bureau, Zhejiang Provincial Department of Finance and Zhejiang Provincial Health Committee, the “Basic Medical Insurance — Reimbursement-by-disease for outpatients with Hepatitis C (Antiviral Therapy)” program will be launched in Zhejiang Province. Ganovo® (Danoprevir) is eligible for the Basic Medical Insurance of Zhejiang Province — Reimbursement-by-disease for outpatients with Hepatitis C. Ascletis’ second direct-acting antiviral agent (DAA), Category 1 new drug — Ravidasvir will also be eligible for the Basic Medical Insurance of Zhejiang Province — Reimbursement-by-disease for outpatients with Hepatitis C once it is approved by National Medical Products Administration (NMPA). Ganovo® entry into the Basic Medical Insurance of Zhejiang Province — Reimbursement-by-disease for outpatients with Hepatitis C is another significant advancement for patient access to Ganovo® after its enrollment in Tianjin Basic Medical Insurance Program under capped-reimbursement per patient pilot program, Chengdu Basic Medical Insurance and Shaoxing government funding subsidy program.
Ganovo® is the first 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, 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, “We greatly appreciate Zhejiang Provincial Medical Insurance Bureau, Zhejiang Provincial Department of Finance and Zhejiang Provincial Health Committee for their attention and care for Hepatitis C patients. The timely introduction of the reimbursement policies will greatly benefit Hepatitis C patients to gain access to high efficacy DAA such as Ganovo®. With Ganovo® entry into the Basic Medical Insurance of Zhejiang Province — Reimbursement-by-disease for outpatients with Hepatitis C, this will allow for more Hepatitis C patients in China to access and benefit from Ganovo® treatment regimen. Ganovo® reimbursement success reflects the strong endorsement and validation of Ganovo® regimen’s efficacy and safety profile from clinical community. In addition, this also demonstrates that domestic innovative drugs can compete effectively against imported drugs in terms of efficacy, safety and pharmacoeconomic value.”