Ascletis announced that China Food and Drug Administration (CFDA) has approved its Category 1 new drug, Ganovo (also known as Danoprevir or ASC08), for the treatment of viral hepatitis C. Ganovo is the first Direct-acting Anti-viral Agent (DAA) developed by a domestic company in China and has been selected as a National Science and Technology Major Project for “Innovative Drug Development”.
Ganovo inhibits 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 percent (SVR12) in genotype 1 non-cirrhotic patients, with a 12-week treatment duration.
In addition, several clinical trials have been conducted in Taiwan, USA, Europe, South Korea and Thailandearlier. The results show that Ganovo regimen demonstrated a cure rate of 91 percent and 100 percent in genotype 1 cirrhotic patients and genotype 4 non-cirrhotic patients, respectively.
Professor Wei Lai, the principal investigator of Ganovo’s clinical trials and former Chairman of the Chinese Society of Hepatology of the Chinese Medical Association said, “Ganovo has shown excellent efficacy and safety in clinical trials and is an HCV cure developed by a domestic company.”
“The successful development of Ganovo fulfilled our commitment to deliver affordable innovative drugs for the Chinese patients.” said Jinzi J. Wu, Ph.D., Ascletis’ founder, president and CEO. “This is a significant achievement of the Chinese government’s major efforts to enhance domestic enterprises’ innovative ability, speed up approvals of new drugs, and improve the ecosystem to enable accelerated development of innovative drugs.”
In addition to successful development of Ganovo, Ascletis has completed the Phase II / III clinical trial for Ravidasvir, a new generation HCV NS5A inhibitor. The results show that Ravidasvir, combined with Ganovo as an all-oral regimen, offers a 99 percent cure rate (SVR12) in genotype 1 non-cirrhotic patients, and a 100 percent cure rate for patients with baseline NS5A resistance mutations. NDA submission for Ravidasvir is expected in the 3rd quarter of 2018.
(Source: Ascletis Pharmaceuticals Co., Ltd.)
Filed Under: Drug Discovery
