Weigh! China's first indigenous original anti hepatitis C innovative drug approved for market

GOLLY today announced that the first innovative anti hepatitis C drug developed by the company, gonovir ® (asco8), has been approved for marketing by the State Drug Administration As the first direct acting anti viral drug (DAA) developed by local enterprises in China, gonovi ® has been supported by the 13th five year national science and technology major special project "major new drug creation" Gonovi is a new generation of NS3 / 4A protease inhibitor with independent intellectual property rights developed by Geli The results of phase III clinical trials completed in mainland China show that after 12 weeks of treatment, the cure rate (svr12) in patients with gene 1 non cirrhosis is 97%; gonovi has completed a number of clinical trials in Taiwan, Europe, America, Thailand, South Korea and other countries and regions The data showed that the cure rate was 91% in patients with genotype 1 cirrhosis and 100% in patients without genotype 4 cirrhosis In vitro studies have shown that gonovi ® has strong activity on NS3 / 4A protease of gene 1-6 "I'm very pleased that China's first indigenous innovative drug for hepatitis C, gonovi, has been approved for marketing," said the chief technology engineer of national major new drug creation science and technology This is a major achievement of the national major new drug creation science and technology project, which shows that the innovation ability of Chinese pharmaceutical enterprises is continuously strengthened and breakthroughs have been made in the field of major disease prevention and control We hope that Geli can make a unique and significant contribution to the prevention and control of hepatitis C in China " Professor Wei Lai, director of the Institute of Hepatology, Peking University People's Hospital, former chairman of Hepatology branch of Chinese Medical Association and the main researcher of the clinical trial of gonovi, said: "gonovi has shown excellent effectiveness and safety in clinical trials The Chinese power to cure hepatitis C, come on! " "The successful launch of gonovi ® has fulfilled the commitment of Geli to provide affordable and innovative drugs for Chinese patients." "This is one of the major achievements of the Chinese government in improving the independent innovation ability of local enterprises, accelerating the review and approval of innovative drugs, and improving the ecological environment for new drug creation," said Wu JINZI, the founder, chairman and President of Geli In addition to the approved gonovi ®, another innovative anti HCV class 1 drug developed by Geli, ravidavir (a new generation of full genotype NS5A inhibitor), has also completed the phase II / III clinical study The first all oral interferon free regimen composed of ravidavir and gonovi ®, originally developed in China, has a cure rate of 99% in patients with type 1 non cirrhosis (svr12), and NS5A resistant mutations have occurred at baseline Svr12 was achieved in 100% of patients Geli plans to submit a new drug listing application in the third quarter of 2018.