Therapy Areas: AIDS & HIV
China FDA Grants Ascletis NDA Approval for Ganovo
15 June 2018 - - Hangzhou, China-based biotechnology company Ascletis has received China Food and Drug Administration approval for its Category 1 new drug, Ganovo (also known as Danoprevir or ASC08), for the treatment of viral hepatitis C, the company said.
Ganovo inhibits hepatitis C virus 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 genotype 1 non-cirrhotic patients, with a 12-week treatment duration.
Results from several earlier clinical trials conducted in Taiwan, USA, Europe, South Korea and Thailand show that Ganovo regimen demonstrated a cure rate of 91% and 100% in genotype 1 cirrhotic patients and genotype 4 non-cirrhotic patients, respectively.
Ascletis' mission is to address unmet medical needs in three therapeutic areas: anti-viral, cancer, and fatty liver disease, for the patients in China and worldwide.
With a fully integrated anti-viral platform covering the entire value chain from discovery and development to manufacturing and commercialization, the company is focusing on developing and commercializing innovative, best-in-class drugs against HCV, HIV and HBV.
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