Regulatory Affairs

Ascletis' Ganovo gets CFDA approval for treatment of viral hepatitis C

Published 13 June 2018

The China Food and Drug Administration (CFDA) has approved Ascletis' Category 1 new drug, Ganovo (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% (SVR12) in genotype 1 non-cirrhotic patients, with 12-week treatment duration.

In addition, several clinical trials have been conducted in Taiwan, US, Europe, South Korea and Thailand earlier. The results show that Ganovo regimen demonstrated a cure rate of 91% and 100% in genotype 1 cirrhotic patients and genotype 4 non-cirrhotic patients, respectively.

National Science and Technology Major Project for "Innovative Drug Development” technical Supervisor Sang Guowei said: "I am very glad that Ganovo is approved by CFDA as the first domestically developed DAA.

“This is a great achievement of the National Science and Technology Major Project, which demonstrates that the innovation capability of Chinese pharmaceutical enterprises is constantly strengthening, and has made a breakthrough in the prevention and control of major diseases.

“I sincerely hope that Ascletis will make a unique and significant contribution to the elimination of HCV disease in China."

Ganovo clinical trials principal investigator Wei Lai said: "Ganovo has shown excellent efficacy and safety in clinical trials and is an HCV cure developed by a domestic company."

Ascletis founder, president and CEO Jinzi Wu said: "The successful development of Ganovo fulfilled our commitment to deliver affordable innovative drugs for the Chinese patients.

"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% cure rate (SVR12) in genotype 1 non-cirrhotic patients, and a 100% cure rate for patients with baseline NS5A resistance mutations.

NDA submission for Ravidasvir is expected in the third quarter of 2018.

Source: Company Press Release.