Change of hepatitis C drug market: three new foreign drugs pass the technical review

Source: caixin.com.2017-03-22 Abstract: three kinds of hepatitis C specific drugs have completed technical review and are expected to be listed as soon as possible; the market of hepatitis C drugs may be reshuffled, but the price of new drugs is still unknown [health] patients with hepatitis C will soon be given new specific drugs Recently, Caixin reporter learned exclusively from CFDA that three kinds of direct anti HCV specific drugs, namely cimerevir, ashurevir and dalatavir, have completed technical review and are in the process of clinical data verification, which is expected to be listed in the near future The three drugs that passed the technical review came from two foreign companies Among them, Xi'an Janssen Pharmaceutical Co., Ltd is responsible for the declaration of cimerevir, and ashurevir and dalatawei are responsible for the declaration of Bristol Myers Squibb (China) Investment Co., Ltd on behalf of Bristol Myers Squibb According to who, hepatitis C is a liver disease caused by hepatitis C virus (HCV) There are many genotypes of hepatitis C, and no vaccine is available Patients with chronic hepatitis C infection may develop cirrhosis and liver cancer later In 2008, the national health and Family Planning Commission released a group of seroepidemiological survey results, which showed that at that time, there were nearly 40 million people infected with hepatitis C virus in China, with an average infection rate of 3.2%, that is to say, one out of every 30 Chinese people infected with hepatitis C This number is still increasing What is the advantage of new drugs? According to the guideline of hepatitis C treatment in China in 2015, interferon is the first choice For a long time, the standard therapy of interferon injection and ribavirin has long curative effect, large side effects and low cure rate Generally speaking, the treatment period is 24-48 weeks, and the cure rate is 40% - 70% If the patient cannot be cured, long-term medication is needed to control the condition The three drugs mentioned above are direct antiviral drugs (DAA drugs for short) This kind of drug is a small molecule drug that can directly resist the virus It can precisely inhibit the protease or other sites of hepatitis C virus and block virus replication by using small molecule compounds When the treatment is oral, the majority of patients can be cured after a short course of treatment compared with traditional therapy The food and Drug Administration told Caixin that the DAA combined program can increase the virus response rate of the relatively difficult to cure genotype 1 hepatitis C patients from 40% to more than 90% It can also shorten the treatment period of hepatitis C to 12-24 weeks If new drugs can be listed in China, it is undoubtedly a great blessing for hepatitis C patients As early as December 6, 2013, the first oral hepatitis C drug in the world, suofebuvir, produced by Gilead science company, a well-known pharmaceutical company in the United States, was approved by the food and Drug Administration of the United States for listing Because of its better efficacy and more convenient than injection drugs, DAA drugs have been favored by patients, and thus set off the global hepatitis C drug market Since then, DAA drugs have been listed, but none of them have been approved to enter China At present, a number of foreign clinical treatment guidelines, such as the European Society of Hepatology "guidelines for the diagnosis and treatment of hepatitis C virus infection", who "guidelines for the prevention and treatment of hepatitis C", have recommended DAA drug treatment programs According to the report of evaluatepharma, an industry and market research company in the field of health care, the market size of anti hepatitis C drugs soared from 5 billion US dollars in 2013 to 24 billion US dollars in 2015 However, in the Chinese market, the DAA specific drug for the treatment of hepatitis C has been hard to find If patients want to take DAA drugs to get better results, they can only go abroad for treatment Doctors in domestic hospitals have no right to prescribe medicine to patients The regulatory authorities finally gave a green light until August 2015, when the State Council issued the opinions on the reform of the review and approval system for pharmaceutical and medical devices, and proposed to accelerate the review and approval of new drugs urgently needed in clinical practice, cimerevir and other hepatitis C specific drugs were included in the priority review procedure In addition to cimerevir, ashurevir and dalatawei, according to the list published by CFDA in April 2016, four kinds of imported hepatitis C drugs, such as obipali tablets of Albright Pharmaceutical Trading Co., Ltd and three hepatitis C drugs made in China, such as asc16 tablets of Geli Biotechnology (Hangzhou) Co., Ltd., were also included in the priority review process In addition, the General Administration of food and drug told Caixin that a number of innovative hepatitis C drugs have been approved to carry out clinical trials in China, and companies such as Kelun Pharmaceutical Co., Ltd and Shiyao group are applying for generic drugs of sofibuwei, a star product However, the three kinds of imported hepatitis C drugs were first approved, or will open the prelude of the domestic market competition of hepatitis C drugs How to solve the price dilemma? However, DAA drugs are currently generally expensive Caixin's reporter consulted a website dedicated to hepatitis C tourism as a patient Pepsi Shimei is a Japanese company Its introduction said that when it went to Japan, the two drugs were used together They are suitable for hepatitis C type 1 patients The treatment cycle is 24 weeks, and the price is 3 million yen, about 150000 yuan And the price of cimerevir of Johnson & Johnson is not low As a part of the combined antiviral treatment program, it cannot be treated with a single drug If you go to the United States, the official price of adult patients with chronic hepatitis C is 790 US dollars per tablet, the treatment cycle is 12-48 weeks, the approximate cost is 70000-140000 US dollars, about 490000-980000 RMB yuan However, due to some differences in European pricing and in various regions of the United States, prices fluctuate up and down In order to obtain better curative effect, some patients always choose to buy cheap generic drugs in neighboring India With the permission of "strong imitation" of foreign drugs, India's generic pharmaceutical industry is developed and the drug price is low, which is known as the "world pharmacy" Lu Yong, the first person to buy anti-cancer drugs in China, helped patients to buy cheap anti-cancer drugs free of charge in India, which was once recognized as "selling fake drugs" by relevant agencies, causing a storm The pharmaceutical companies have not disclosed how the above drugs will be priced in the future.