Geli applied for the first clinical trial of full oral hepatitis C treatment scheme independently developed in China
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Last Update: 2015-06-24
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Source: Internet
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Author: User
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China's innovative drug development company, today (June 24th), announced that the clinical trial application of the all oral anti interferon chronic hepatitis C treatment scheme was accepted by the State Food and Drug Administration (CFDA) and the food and Drug Administration of Taiwan (TFDA) The program is composed of two direct antiviral drugs (DAA), asc16 and asc08 It is the first all oral interferon free hepatitis C treatment program developed by Chinese enterprises This is another significant progress of Geli in the field of hepatitis C treatment, following the successful completion of its first DAA asc08 phase II clinical trial in Taiwan with good results "The all oral interferon free program is a new breakthrough in the field of hepatitis C treatment abroad in 2014, but at present, there is no DAA listed in China, and there is no all oral interferon free chronic hepatitis C treatment program." Zhuang Hui, academician of Chinese Academy of engineering, honorary chairman of Hepatology branch of Chinese Medical Association and professor of Peking University Medical Department commented, "we are very pleased that Geli is the first to launch a full oral interferon free treatment program in China, which shows that the research of domestic pharmaceutical enterprises in the field of DAA hepatitis C treatment has been in line with international standards, and is of great significance to promote the prevention and treatment of hepatitis C in China." "After asc08 was unanimously recognized by experts at home and abroad at the annual meeting of Asian Pacific Society of Hepatology, Geli's efforts in the field of hepatitis C have made exciting new progress today Geli will make every effort to promote this important all oral interferon free chronic hepatitis C treatment program, serving the majority of Chinese patients " Said Wu JINZI, the founder and CEO of Geli Asc08 is a DAA developed by Geli with independent intellectual property rights It belongs to NS3 / 4A protease inhibitor of the second generation of hepatitis C virus (HCV) It has a significant effect on HCV genotype 1 patients As of March 2015, asc08 has completed 34 phase I and phase II clinical trials in countries and regions other than mainland China, including 2400 subjects in the group Recently, the phase II clinical trial of asc08 combined with long-acting interferon and ribavirin in Taiwan showed that after 12 weeks of treatment, the cure rate (svr12) of patients with HCV genotype 1 non cirrhosis was 94%, and that of patients with genotype 1b non cirrhosis was 100% This clinical research report has been officially released at the 24th Annual Meeting of the Asia Pacific Society of Hepatology, and won the honor of special theme report by the president of the meeting Asc16 is an inhibitor of HCV NS5A in DAA, which has synergistic or overlapping effect with other anti HCV DAAS including HCV NS3 / 4A protease inhibitors The results of phase IIa clinical study in Europe and America show that the combination of asc16 and other DAAS including HCV NS3 / 4A protease inhibitors has the characteristics of high cure rate and good safety After 12 weeks of treatment, the cure rate of patients with refractory HCV genotype 1a is as high as 92% About Geli, Geli is a pharmaceutical company based in China and facing the world It is committed to research, development and sales of new drugs for cancer and infectious diseases Founder: Dr Wu JINZI, special expert of national "thousand talents plan", visiting researcher of Institute of medicine, Chinese Academy of Sciences Prior to the founding of Geli, he served as vice president (USA) of GlaxoSmithKline (the world's third largest pharmaceutical company, global top 500 enterprises), responsible for global research and development of new AIDS drugs He also served as vice president of Ambria biopharmaceutical company in Canada, department director of Amgen / immunex, senior researcher and department director of Novartis, senior biochemical scientist and project director of Aventis With 18 years of new drug research and development experience, he is directly responsible for and leads his team to successfully develop a number of world leading clinical new drugs for anti-tumor and infectious diseases Ph.D in cancer biology, University of Arizona, USA Dr Wu JINZI is a famous member of Baihua Association Company's base in China and North America
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