China's first original research on hepatitis C innovative drugs successfully declared
December 30, 2016 Source: Big Health
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On December 27th, China's innovative drug development company Song Li announced today that the company's first original application for the development of hepatitis C innovative drug Danolive (ASC08) has passed the comprehensive on-site inspection by the Zhejiang Food and Drug Administration. Received by the State Food and Drug Administration.
Hepatitis C is a viral hepatitis caused by hepatitis C virus (HCV) infection, which is mainly transmitted through blood transfusion, acupuncture, and drug use. It can cause chronic inflammation, necrosis and fibrosis in the liver. Some patients can develop liver cirrhosis or even hepatocellular carcinoma, which is called "silent killer". Unlike hepatitis B, there is currently no effective vaccine against hepatitis C. Previously, because China did not have antiviral drugs already on the market, patients either received existing interferon programs or received new drugs overseas through various channels.
Danone Reeve triple therapy for Chinese patients with type I hepatitis C for 12 weeks, the cure rate is over 95%. The drug was acquired from Roche. At that time, clinical phase I and phase II were completed abroad. After entering China, the song ceremony quickly completed all clinical trials in China. Clinical research results will be published at the 26th Annual Meeting of the Asia Pacific Association of Liver Diseases in 2017.
China is a big country with liver disease, many patients with chronic hepatitis B and chronic hepatitis C, of ​​which the number of chronic hepatitis C patients is tens of millions, and the statistics range from 10 million to 40 million. Most patients with chronic hepatitis C do not know that they have chronic hepatitis C, which not only harms their health, because it is a contagious disease, but also has a huge impact and harm to family and society. At the same time, the founder of the song ceremony, Wu Jinglian, said that chronic hepatitis C in China is a community-based distribution. In some high-incidence areas, high-incidence cities, and high-incidence villages, there are many patients with chronic hepatitis C.
Professor Chen Kaixian, an academician of the Chinese Academy of Sciences and the deputy chief of science and technology special technology of the National Major Drug Creation System, believes that the achievements of Danuo Ruiwei mark the rise of a group of representative innovative pharmaceutical companies such as songs.
In 2017, based on the successful launch of Danone Reeve, the song will accelerate the research and development of the second hepatitis C drug, Rivedavir, and launch a full oral hepatitis C treatment plan as soon as possible. Revidavir (ASC16) is another innovative hepatitis C virus developed by Gloria. It is combined with Danolivevir to form China's first indigenous original oral non-interferon treatment program. Clinical trial results show that this full oral interferon-free regimen for Chinese patients with type I hepatitis C for 12 weeks has a cure rate of over 95% and can be used for hepatitis C patients who are intolerant to interferon. In April 2016, Revidawe was included in the priority review process by the State Food and Drug Administration.
In September of this year, the factory of the song ceremony has obtained the drug production license. At present, the production capacity of the factory can fully meet the demand of its listing. The first phase of production capacity can produce 300 million pieces. At the same time, the songs have begun to set up a sales team, and the professional marketing system has gradually formed.
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