Ascletis Receives NDA Approval from China FDA for Ganovo

HANGZHOU and SHAOXING, China, June 12, 2018 /PRNewswire/ -- Ascletis announced today 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% (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 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.

Dr. Sang Guowei, vice chairman of the Standing Committee of the 11th National People's Congress, a leading academician of the Chinese Academy of engineering, and the technical Supervisor of National Science and Technology Major Project for "Innovative Drug Development"，commented , "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."

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% 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 3rd quarter of 2018.

SOURCE Ascletis Pharmaceuticals Co., Ltd.