The second domestic new hepatitis C drug clopevir hydrochloride capsule was approved for marketing

Recently, the State Drug Administration approved the listing of clopevir hydrochloride capsule (trade name: kailivi) (Code: kw-136), a class 1 innovative drug of Beijing kaiingering Biotechnology Co., Ltd., through the priority review and approval procedure This product is used in combination with sophibuvir in the treatment of adult chronic hepatitis C virus (HCV) infection of gene 1, 2, 3 and 6, which is initially treated or treated with interferon It may or may not be combined with compensatory cirrhosis Coblopasvir (kw-136) is a kind of NS5A inhibitor, which can inhibit the replication of HCV by targeting NS5A Both of them are NS5A replication complex inhibitors At present, the combination of the two drugs is one of the first choice for the treatment of chronic hepatitis C It does not need to add interferon and ribavirin to relieve the pain of side effects of drugs It is also the first full genotype scheme in China After being put on the market, there is no need to detect the genotype, reduce the economic burden of patients and simplify the diagnosis and treatment process In January 2015, CDE undertook the clinical trial application of kw-136 (chemical medicine 1.1); in May 2016, CDE issued the clinical trial approval; in July 2016, Kaine technology started the first phase of clinical trial; in March 2017, Kaine technology started the second phase of clinical trial of adult chronic hepatitis C (ctr20170073); in June 2017, Kaine technology started kw-136 A phase III clinical trial (ctr20171654) on the treatment of adult chronic hepatitis C by capsule combined with suofebuwei tablet At the 18th National Academic Conference on viral hepatitis and liver disease in October 2017, Professor Niu Junqi from the First Affiliated Hospital of Jilin University, the main researcher, introduced the clinical research on the anti HCV treatment (anti hepatitis C virus) of kw-136, a new all gene NS5A inhibitor made in China The preliminary research data showed that the antiviral activity of kw-136 for gt-1-6 HCV was equivalent to that of the first NS5A inhibitor, dalatawei (DCV), and the effect of kw-136 for gt-3a HCV was better than that of DCV In the phase II study (bjky-2016-006), a total of 110 patients with primary infection and genotype 1 / 2 / 3 / 6 were included, including 98 patients without cirrhosis and 12 patients with compensatory cirrhosis, who were treated with kw-136 combined with sofe for 12 weeks The results showed that the combination of kw-136 and sof could obtain high level SVR, and the safety of kw-136 was not inferior to that of similar drugs (non head to head) The phase III clinical trial of kw-136 capsule combined with suofebuvir in the treatment of adult chronic hepatitis C (ctr20171654) was completed on January 3, 2018, and 360 people were enrolled 12 weeks standard course of treatment, 12 weeks treatment and 12 weeks follow-up after drug withdrawal Single arm test for all genotypes In June 2018, CDE undertook the listing application of kw-136 and was included in the priority review and approval of major projects According to the 2015 version of guidelines for the prevention and treatment of hepatitis C jointly issued by hepatology branch and infectious diseases branch of Chinese Medical Association, there are about 10 million people infected with hepatitis C virus in China, and there is a huge market demand for hepatitis C drugs in China According to insight database, 13 of the previous priority review lists are anti hepatitis C drugs / viral hepatitis in the status of listing application or listing, and the competition between local enterprises and foreign enterprises in the approval of hepatitis C drugs is very fierce In addition to kw-316, there are also ravidavir hydrochloride tablets of Geli bio in the application for listing, while sh229 tablets of Nanjing Shenghe, yinglaibuwei sodium tablets of dongyangguang pharmaceutical and vorarevir tablets of Taijing pharmaceutical are in the clinical trial, and subsequent applications for listing will be submitted one after another, and the avenue of hepatitis C drugs will be more and more crowded At the end of 2019, the results of the new health care negotiation were announced, and Gilead's ledipa vesophos tablets (Chardonnay) and vesophos tablets (bingtongsha) were released