The first new hepatitis C drug was approved! The market war of foreign enterprises started, followed by Geli

Propionoxar (suzophtbuvir 400 mg / vpatavir 100 mg) has been approved by the National Drug Administration for the treatment of adult patients with gene 1-6 chronic hepatitis C virus (HCV) infection, Gilead science announced today At the same time, the State Drug Administration approved the combination of propranolol and ribavirin (RBV) for adult patients with hepatitis C and decompensated cirrhosis It is worth mentioning that propionoxate is the first pan genotype HCV single tablet protocol (STR) approved in China This is another new plan for the treatment of hepatitis C approved after the approval of the new drug, elbawegrarevir (English trade name zepatier), in early May Up to now, eight new oral hepatitis C drugs have been approved for marketing in China, including ashuribe, dalatavir, simirevir, dasebovir, obipali, sophibuvir, elbawegrarevir and sophibuvir No new domestic drug has been approved The domestic approved new oral hepatitis C drugs (part of the information comes from the drug cube data) China's hepatitis C market pattern will change to the drug cube data shows that the global hepatitis C market pattern in 2017 has been settled, and the overall market scale is set at about 13 billion US dollars During the five years from 2013 to 2017, the global hepatitis C market exploded from US $3.2 billion to US $23.7 billion, and then shrank sharply to US $12.5 billion due to price competition and reduction of patient pool Compared with the previous year, the performance of Gilead in 2017 also declined significantly However, if the two new all gene hepatitis C drugs epclusa and vosevi are included, the revenue of Gilead's hepatitis C business in 2017 reached $9.137 billion, even better than expected After a round of competition in the global hepatitis C market, with the improvement of cure rate, the market is also shrinking, and pharmaceutical companies are looking to China Although hepatitis C is not as large as hepatitis B in China, its mortality rate is second only to hepatitis B According to the data from the disease control bureau of the former national health and Family Planning Commission, in 2017, according to the statistics of national legal infectious diseases, the top five diseases in class B are viral hepatitis, tuberculosis, etc., and the number of deaths are also the top two diseases Among them, the incidence rate and mortality rate of hepatitis B is the highest among viral hepatitis, and the second is hepatitis C According to the report released by China Hepatitis Prevention Foundation, about 7.6 million people are infected with hepatitis C in China, and about 330000 people die of cirrhosis and primary liver cancer caused by hepatitis B or hepatitis C infection every year Due to the lack of breakthrough anti HCV treatment, only about 74000 patients were treated in 2017, with a cure rate of only 0.3% Among them, HCV genotype 1, 2, 3 and 6 accounted for more than 96% of all cases Therefore, the market potential of breakthrough hepatitis C treatment in China is huge In response to this market demand, the government approved four all oral direct anti HCV (DAA) therapies in 2017 Compared with the existing treatment schemes of pegylated interferon and ribavirin for HCV, DAA has higher cure rate, shorter treatment cycle, better safety and tolerance With the introduction of DAA in 2017, China's patients and doctors are looking forward to effective treatment of HCV, and the competition pattern of China's market and HCV treatment is expected to change significantly It is understood that in China, there are three types of current and next generation hepatitis C therapies The first one is pegylated interferon combined with gabaverin; the second one is DAA + PR; the third one is DAA all oral therapy BMS cooperated with Shanghai Pharmaceutical and insurance institutions to carry out market promotion work such as "pay for curative effect" innovative insurance project immediately after the "ashuribe" + "dalatawei" combination was first approved for listing Gilead's sophibuvir has been approved for use in combination with other drugs in the treatment of adult pan genotype and 12-18-year-old children with genotype 2 and 3 hepatitis C, and can be cured According to the company, the retail price of sophopewell in the mainland market is 19660 yuan / bottle, and the price of a course (12 weeks) is 58980 yuan At present, the price of dacatavir is about 20000 yuan / treatment course, which means that a course of treatment of sophobuvir + dacatavir (EU combination) for hepatitis C patients needs about 80000 yuan Although the price of domestic new drugs is relatively low compared with that of the United States, it is not a small expense for domestic hepatitis C patients Obviously, the accessibility of direct acting antiviral drugs is still limited, which is a global phenomenon In order to effectively control the development of hepatitis C in Cambodia, Wang Wei, a Chinese consultant for MSF's "patients have their own medicine" project, said that his public welfare organization obtained a purchase agreement for hepatitis C generic drugs, with the price as low as $1.40 per day, that is, only $120 per 12 week course of treatment for two key drugs, sophibuvir and dakatavir The agreement comes from a voluntary license agreement signed by Gilead and Indian generic companies, so that the company's products can avoid being forced to copy, and patients can buy cheaper generic drugs in India, even though sophopewer is still in the patent period As a newly approved propranolol, how about the price of a single tablet when it is convenient for patients to use? Dr John F Milligan, President and CEO of Gilead science company, pointed out that as the first single dose treatment plan that does not need to consider the genotype and degree of liver fibrosis of HCV patients once a day, bingtongsha greatly simplifies the treatment of HCV patients by Chinese doctors, and is expected to reduce the huge burden of HCV on public health At present, many domestic enterprises are developing hepatitis C drugs The R & D work of 10 enterprises, including Zhengda Tianqing Pharmaceutical Co., Ltd., Sichuan Kelun, Fujian Haixi new drug development Co., Ltd., Nanjing Xiansheng Dongyuan, Zhejiang Haizheng, Zhongqi, Jiangxi Shimei, Beijing Wansheng, Zhejiang Huahai, is in full swing In March 2017, suophobuvir of Shanghai Hequan Pharmaceutical Co., Ltd was approved for clinical application Gorey's Nuo Ruiwei, the first HCV treatment drug developed by a domestic company near the commercialization stage, is expected to be launched in China by the third quarter of 2018 Another product of Geli, ravidavir, is the best of its kind, pan gene DAA for NS5A target of hepatitis C When ravidavir, gonovide and ribavirin are taken at the same time, they constitute a full oral HCV treatment plan without interferon, i.e BDV / CNV treatment plan This program is the first HCV treatment program developed by a domestic company that has completed phase III clinical research without interferon It is expected to submit a new drug application in China by the third quarter of 2018 It is because of the huge market, for Geli, the company's drugs in research are also facing fierce competition According to the F & s report, there are many multinational and domestic companies in China to conduct the DAA clinical trials for the treatment of hepatitis C Gilead and mosadon have two therapies, which are also competing therapies for gelly With the gradual development of gonoway, golly also began to consider building a commercial team At the beginning of 2016, the company began to establish a commercialization team to lay the foundation for the commercialization of the first batch of products and formulate targeted marketing strategies The company has established a commercial team of about 145 members, covering more than 850 hospitals which are located in the extensive strategic position of China hepatitis C organizing committee The main work includes pre-sales Market Research and patient analysis, brand building, identification and education of about 5500 experts and key opinion leaders in the field of hepatitis.