China's first local new hepatitis C drug has been approved for market, 5 pharmaceutical companies are fighting fiercely, Gilead's dominant position is dangerous

Recently, Geli announced on the official website that the company's first domestic new drug, danorevir sodium tablet (also known as danorevir sodium tablet, trade name: gonovi), which was originally researched and developed by itself, was approved by the State Drug Administration for listing Since 2017, 6 hepatitis C drugs from 5 pharmaceutical companies in China have been approved for listing, with the exception of Geli, the rest are multinational enterprises In addition, in the list of drugs that have been included in the priority review, in addition to those that have been approved for marketing, there are 18 acceptance numbers (involving 11 varieties) for hepatitis C drugs, including 3 imported varieties On June 13, geley announced that its independently developed new hepatitis C Class 1 drug danorevir sodium tablet (also known as danorevir sodium tablet, trade name: gonovi) has been approved by the State Food and Drug Administration for listing According to the meddrug evaluation database 2.0 data on the intranet, geley's danorevir sodium The piece is in the approved pending status Figure 1: review and approval of danorevir sodium tablets (click the picture to enlarge) (source: meed drug review database 2.0) gonovi is the first approved product of Geli and the first hepatitis C DAA (direct antiviral) drug independently developed by domestic enterprises On January 3, 2017, gonovi's listing application was accepted by CDE with the acceptance number of cxhs1600012, October 30, 2017 The acceptance number entered the three in one review sequence On June 11, 2018, the approval of the State Food and drug administration was completed and production was approved It took 524 days from the application for listing to the approved listing Figure 2: time axis of danorevir sodium tablets review (click the picture to enlarge) (source: Med drug review database 2.0 of minenet) In May this year, Geli formally submitted an IPO application to the Hong Kong stock exchange In the new IPO rules of Hong Kong stock market, one of the conditions for allowing unprofitable biotechnology companies to go to Hong Kong for listing is that the biotechnology companies to be listed will receive a considerable amount of third-party investment at least six months before the proposed listing date, and at least one core product has passed the concept development process For golly, the listing of gonoway is undoubtedly a strong support for the company's IPO sprint Sang Guowei, vice chairman of the Standing Committee of the Eleventh National People's Congress, academician of the Chinese Academy of engineering and chief technical engineer of national major new drug creation technology, said: "I'm very glad that China's first indigenous innovative drug for hepatitis C, gonovi, has been approved for listing This is a major achievement of the national major new drug creation science and technology project, which shows that the innovation ability of Chinese pharmaceutical enterprises is continuously strengthened and breakthroughs have been made in the field of major disease prevention and control " The listing of gonovi broke the monopoly situation of domestic hepatitis C drug market by multinational pharmaceutical companies Before Geli, domestic anti hepatitis C drugs of Gilead, Alberto, Bristol Myers Squibb, MSD and other multinational enterprises were approved for listing Although the listing time of gonovi is later, if it can successfully enter the medical insurance catalog in the future, it may be able to replace the original research by virtue of price advantage Products occupy most of the market Multinational enterprises have turned to five pharmaceutical enterprises in China Who will dominate? Hepatitis C is a viral hepatitis caused by hepatitis C virus (HCV) According to the 2017 global hepatitis report released by the World Health Organization, there are about 325 million people infected with chronic hepatitis B virus or hepatitis C virus in the world With the popularity and application of hepatitis B vaccine, the incidence rate of hepatitis B has decreased Compared with the prevention and control strategy of hepatitis B, there is no vaccine to prevent hepatitis C, and its incidence is showing a sharp upward trend China is a "big country of hepatitis C", with 96% of all cases of hepatitis C virus being genotype 1, genotype 2, genotype 3 and genotype 6, which promotes the continuous expansion of hepatitis C drug market Table 1: hepatitis C DAA drugs approved for marketing in China since 2017 (click the picture to enlarge) (source: minenet database) Since 2017, a number of hepatitis C DAA drugs have been approved for listing in China, which are respectively attributed to Bristol Myers Squibb, Gilead, Alberto, mosadong and Geli The two drugs of Bristol Myers Squibb and Alberto are combined drugs The listing of Geli new hepatitis C drugs breaks the monopoly situation of domestic hepatitis C drug market by multinational pharmaceutical companies   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> Gilead: sophobovir tablets, sophobovir / vipatavir tablets, sophobovir tablets (trade name: suowati), are nucleoside polymerase inhibitors against hepatitis C virus, which were listed in the United States in December 2013, and are applicable to some hepatitis C genotypes, with a cure rate of more than 90% The global sales of suowati in 2017 was US $964 million, a sharp decline compared with the sales in previous years Figure 3: global sales of sophopewell tablets from 2014 to 2017 (unit: USD million) (source: sales base of Mnet multinational listed companies) In September 2017, suowaldi was approved to be listed in China In November 2017, Geely announced that suowaldi's final price in China was 19660 yuan / bottle, and the sales specification was 28 pieces / bottle According to a treatment course every three months, the price of a treatment course was 58980 yuan, which is still a self financed project at present Sophibuvir / vpatavir tablet (trade name: bingtongsha) is the first approved pan genotype, once a day, single tablet for chronic hepatitis C virus in China, which is suitable for adult patients with genotype 1-6 HCV According to the data of five international multicenter phase 3 clinical studies, the overall realization rate of svr12 (defined as the 12th week after completion of treatment, no HCVRNA can be detected) is 92% - 100% in the group of patients who are difficult to cure (including the treated patients, as well as the patients with compensated or decompensated cirrhosis) Figure 4: global sales of sophopewell / viatavir tablets in 2016-2017 (unit: US $million) (source: sales base of Mnet multinational listed companies) bingtongsha was approved for listing in the United States and the European Union in 2016, and has been approved for listing in 54 countries so far Its global sales in 2017 was US $3510 million, an increase of 100.34% over the previous year   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> Bristol Myers Squibb: dhaltamivir hydrochloride + ashurevir soft capsule dhaltamivir hydrochloride (trade name: thyme), an NS5A inhibitor of hepatitis C virus, ashurevir soft capsule (trade name: speedup) It is the second generation protease inhibitor developed by Shiguibao company The all oral combination therapy of dalatawei tablet and ashureway capsule was approved in Japan in 2014, becoming the first clinical scheme for all oral, interferon free treatment of hepatitis C gene 1 patients, including decompensated cirrhosis and hepatitis C patients in Japan Global sales in 2017 were $406 million, down sharply from last year Figure 5: global sales of dalatavir hydrochloride + ashurevir soft capsules (unit: US $million) (source: Sales Library of Mnet multinational listed companies) After Bristol Myers Squibb's "ashuribe" + "dalatawei" portfolio was approved to be listed in China in June 2017, it immediately cooperated with Shanghai Pharmaceutical and insurance institutions to carry out the market promotion work such as "pay as you go" innovative insurance project According to the clinical research results of patients included in the mainland of China, the cure rate of the combined therapy for gene 1b chronic hepatitis C patients is 91% ~ 99%, with good safety and tolerance   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> Albuquer: obipali tablets + dasebovir tablets obipali tablets (trade name: weijianle) is an anti HCV compound preparation composed of obitavir, paliravir and litonavir Dasebovir tablets (trade name: yichery) belong to non nucleoside polymerase inhibition preparations At present, the combination of weijianle and yichery has been approved in more than 70 countries and regions around the world for clinical treatment of patients with genotype 1 chronic hepatitis C The treatment plan of weijianle combined with yichiri includes three kinds of direct antiviral drugs, namely NS5A inhibitor, NS3 / 4A protease inhibitor and NS5B polymerase non nucleoside analogue inhibitor, which can inhibit the replication of hepatitis C virus against three main targets in the life cycle of hepatitis C virus In September 2017, the treatment plan was approved for marketing in China and approved by the State Drug Administration in March 2018 The treatment course was shortened from the original 12 weeks to 8 weeks   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> mosadon: elbawegrarevir tablet, elbawegrarevir tablet (trade name: sebida), a fixed dose compound tablet composed of elbawer and grarevir, is used for the treatment of patients with chronic hepatitis C who are initially treated with gene 1 or type 4 or relapsed after treatment with a course of 12 weeks every day In 2017, the global sales volume was US $1660 million, up 199.1% year on year Figure 6: global sales of elbawegradrave films (in millions of US dollars) in 2016-2017 (source: sales base of Mnet multinational listed companies) none = "shifumousedownstyle ('shifu bus')" style = "margin: 1em Auto; 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