How does the market of hepatitis C drugs change when BMS double weight products are launched?
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Last Update: 2017-04-28
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Source: Internet
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Author: User
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On April 28, CFDA official website announced the approval of the combination therapy of BMS dalatavir hydrochloride and ashurevir soft capsule for hepatitis C, and another strong march into the fierce market of hepatitis C drugs in China On April 28, CFDA announced that daclatasvir (DCV) and asunaprevir (ASV) of BMS were approved to be imported and listed recently for the joint treatment of adult gene 1b chronic hepatitis C In addition, DCV has also been approved for use in combination with other drugs, such as sophibuvir, in the treatment of chronic hepatitis C virus infection in adults Previously, the combination of DCV and ASV in the treatment of hepatitis C has been approved in Japan in 2014, becoming the first clinical scheme for all oral, interferon free treatment of hepatitis C genotype 1 patients in Japan, including patients with decompensated cirrhosis and hepatitis C Chronic hepatitis C (CHC) is a common chronic serious infectious disease With the progress of the disease, it gradually develops into cirrhosis and liver cancer The results showed that in Chinese chronic hepatitis C patients, genotype 1b accounted for 98% of genotype 1 and 57% of all hepatitis C patients DCV is a selective inhibitor of HCV nonstructural protein 5A replication complex, which has high specificity for multiple HCV genotypes / subtypes and low toxicity to host cells ASV is a selective non structural protein 3 protease inhibitor of hepatitis C virus Before that, the standard treatment of CHC in China was pegylated interferon combined with ribavirin, the cure rate was only 44% - 70% In contrast, direct anti HCV drugs (DAA) are more effective in the treatment of hepatitis C DCV and ASV are DAA drugs developed by BMS According to the clinical research results of patients included in the mainland of China, the cure rate of DCV and ASV combined treatment scheme for gene 1b chronic hepatitis C patients is 91% ~ 99%, with good safety and tolerance With a huge Chinese market of 43 million hepatitis C patients, many domestic and foreign pharmaceutical enterprises participate in the scuffle, and the competition will be very fierce The combination of DCV and ASV in the treatment of hepatitis C was approved in China, which injected fresh blood into the domestic competitive hepatitis C drug market At present, there are mainly three companies in China that have the DAA drug pipeline of hepatitis C, including Geli pharmaceutical, dongyangguang pharmaceutical and gingko tree pharmaceutical Among them, danoprevir (asc08) of Geli pharmaceutical has the fastest progress At the same time, according to the public information, at the beginning of 2016, there were more than 40 registration application acceptance numbers related to sofibove in China, and many large enterprises such as Zhengda Tianqing, hausen, Qilu, Haizheng, Huahai and Kelun were queuing up to apply for sofibove clinical approval documents In addition, Gilead company, which owns heavyweight hepatitis C drugs sovaldi and harvoni, has published three phases of clinical trial data of its product sovaldi in China earlier Gilead has also established entity operation companies in China, including China operation center in Shanghai and R & D and production base in Hangzhou, which shows its determination to enter the hepatitis C drug market in China Multinational giants such as MSD and Aberdeen are also laying out the market of hepatitis C drugs in China CFDA said that it will continue to speed up the review of oral direct anti HCV drugs and promote the listing of such drugs.
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