Songli declaration of the first domestic self-developed full oral hepatitis C treatment program clinical trial
June 26, 2015 Source: Medical Valley Network
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)];China's local innovative drug development company Song Li announced today that the company's application for clinical trials of oral anti-interferon chronic hepatitis C treatment has been approved by the State Food and Drug Administration (CFDA) and the Taiwan Food and Drug Administration of the Ministry of Health and Welfare ( TFDA) accepted. The program consists of the company's two direct antiviral drugs (DAA) ASC16 and ASC08. It is the first fully oral interferon-free hepatitis C treatment program developed by Chinese local companies. This is another major advancement in the field of hepatitis C treatment following the successful completion of its first DAA ASC08 Phase II clinical trial in Taiwan and good results.
“The full oral anti-interferon program is a new breakthrough in the field of hepatitis C treatment in foreign countries in 2014, but at present there is no DAA listed in China, and there is no complete oral interferon-free chronic hepatitis C treatment program.†Academician of Chinese Academy of Engineering, Honor of Chinese Medical Association Hepatology Branch Chairman Zhuang Hui, a member of the Peking University School of Medicine, commented, "We are very pleased that the song is the first in China to introduce a full oral anti-interferon treatment program, indicating that domestic pharmaceutical companies have been in line with international research in the field of DAA hepatitis C treatment. Hepatitis C prevention and treatment is of great significance."
"After ASC08's unanimous recognition by domestic and foreign experts at the annual meeting of the Asia-Pacific Association of Liver Diseases, the efforts of the songs in the field of hepatitis C, there are exciting new developments today. The gift will fully promote this important full oral exemption. Interferon chronic hepatitis C treatment program, serving the majority of Chinese patients." Song Li founder and CEO Dr. Wu Jinqi said.
ASC08 is a DAA with independent intellectual property rights developed by Songli. It belongs to the second generation of hepatitis C virus (HCV) NS3/4A protease inhibitor and has a significant effect on patients with HCV gene type 1. As of March 2015, ASC08 has completed 34 Phase I and Phase II clinical trials in other countries and regions outside mainland China, with a total of 2,400 participants. Phase II clinical trials of ASC08 and long-acting interferon and ribavirin, which were recently completed in Taiwan, showed a cure rate for patients with HCV genotype 1 non-cirrhosis after 12 weeks of treatment (SVR12) Up to 94%, patients with type 1b non-cirrhotic patients achieved a 100% cure rate. This clinical research report was officially released at the 24th Annual Meeting of the Asia-Pacific Association of Liver Diseases and was honored by the President of the General Assembly.
ASC16 is a HCV NS5A inhibitor in DAA that synergizes or superimposes with other anti-HCV DAAs including HCV NS3/4A protease inhibitors. The results of the Phase IIa clinical study, which has been completed in Europe and the United States, show that ASC16 combined with other DAA including HCV NS3/4A protease inhibitors has a high cure rate and good safety characteristics. After 12 weeks of treatment, the cure rate of patients with refractory HCV genotype 1a was as high as 92%.
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