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    Home > Active Ingredient News > Drugs Articles > China's first indigenous original anti hepatitis C innovative drug approved for market

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

    • Last Update: 2018-06-13
    • Source: Internet
    • Author: User
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    Source: Geli, June 13, 2018, announced today that the first innovative anti hepatitis C drug developed by the company, gonovir ® (asco08), has been approved for listing by the State Drug Administration Gonovi is the first direct acting anti viral agent (DAA) developed by Chinese enterprises, which is supported by the 13th five year national science and technology major 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 In addition to the approved gonovi ®, another innovative anti HCV class 1 drug developed by golly, ravidavir (a new generation of full genotype NS5A inhibitor), has also completed II/ In the phase III clinical study, the first all oral interferon free regimen in China, composed of ravidavir and gonovi ®, achieved 99% cure rate (svr12) in patients with type 1 non cirrhosis, and achieved 100% svr12 in patients with NS5A resistant mutations at baseline Geli plans to submit a new drug listing application in the third quarter of 2018  
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