New hepatitis C drug is on the market in China!

Source: prior to October 18, 2017, State Food and Drug Administration approved the new oral hepatitis C drug sophibuvir tablets of Gilead company, and obipali tablets and dasebovir tablets of abbvie company The advantages of new drugs for hepatitis C are obvious In April last year, 12 drugs for hepatitis C from 7 pharmaceutical companies at home and abroad were included in the priority approval process by the drug approval center (CDE) of the State Food and drug administration Only one year later, new hepatitis C drugs were launched, including Albuquer's obipali tablets, dasebwir sodium tablets and other treatment programs, and a number of new hepatitis C drugs were approved According to who data, hepatitis C is a liver disease caused by hepatitis C virus (HCV) It is divided into several genotypes and no vaccine is available Patients with chronic hepatitis C infection may develop cirrhosis and liver cancer later Before the appearance of direct antiviral drugs for hepatitis C, such as sophibuvir tablets, most patients received interferon based treatment There are some deficiencies in the cure rate, adverse reactions and so on 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 Leigh Bhave Lin has a long therapeutic effect and a large side effect, but the cure rate is not high 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 It is understood that sophibuvir is the first new drug developed by Gilead company that can safely and effectively treat some types of hepatitis C without interferon As early as December 6, 2013, the world's first oral hepatitis C drug, suofibuvir, produced by Gilead science, 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, DAA drugs are more convenient than injection drugs, and are favored by patients Sofebovir is the most concerned new drug in 2013, but it is also controversial due to the high price of $1000 per tablet In January 2014, sofibwe was approved by the European drug administration, and then exploded the global market all the way After that, DAA drugs (direct antiviral drugs can be taken orally during the treatment After a short course of treatment compared with traditional therapy, most patients can be cured.) They have been listed successively, but none of them have been approved to enter China It was not until August 2015 that the State Council issued the opinions on the reform of the review and approval system for pharmaceutical and medical devices, which proposed to speed up the review and approval of clinically urgently needed new drugs, that special hepatitis C drugs such as cimetivir were included in the priority review procedure Sophibuvir tablets, obipali tablets, and dasebovir tablets can be approved in just a few months, thanks to the "green channel" established by the drug priority review and approval policy It took seven months for the four new drugs to be submitted for registration and approved, reaching the time limit for accelerated drug review in Europe and the United States China is the country with the largest number of people infected with hepatitis C virus in the world, with about 10 million people infected The situation of prevention and treatment is very serious On a broader scale, hepatitis C is also one of the major global public issues By the end of 2015, there were about 71 million people infected with hepatitis C virus in the world For these hepatitis C patients, price has always been a heavy burden On September 14, 2013, the Austrian news published a report entitled "it is possible to cure hepatitis C - but it can't be cured", criticizing the high price of sofibove tablets Although the headline of the newspaper is rather funny, it reflects the fact that the price of DAA drugs is generally high Based on the treatment cycle of 12-48 weeks, take cimerevir of Johnson & Johnson The official price is 790 US dollars / piece, and the cost of treatment is about 70000-140000 US dollars, about 490000-980000 RMB yuan Fortunately, new hepatitis C drugs are expected to be included in China's national medical insurance, and now more than 10 pharmaceutical enterprises in China have carried out research and development of related varieties, including Sichuan Kelun, Jiangsu Haosen, Zhengda Tianqing, Shiyao group and other enterprises Perhaps in the near future, many patients are expected to get "life-saving medicine" at a lower price On October 8, the general office of the CPC Central Committee and the general office of the State Council jointly issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical medical devices Article 11: the examination and approval of drug injection shall be strictly carried out Strictly control the change from oral preparation to injection preparation If the oral preparation can meet the clinical needs, the injection preparation will not be approved for marketing Strictly control the change from intramuscular injection preparation to intravenous injection preparation If the intramuscular injection preparation can meet the clinical needs, the intravenous injection preparation will not be approved for listing The application for changing dosage form between large volume injection, small volume injection and sterile powder injection for injection shall not be approved if there is no obvious clinical advantage Article 25: to carry out re evaluation of drug injection According to the progress of pharmaceutical science, the re evaluation of drug injections on the market should be carried out in about 5 to 10 years The listing Permit Holder shall conduct comprehensive analysis on the research situation at the time of approval for listing and the continuous research after listing, carry out research on product ingredients, mechanism of action and clinical efficacy, and evaluate its safety, effectiveness and quality controllability Through re evaluation, we can enjoy the relevant incentive policies of quality and efficacy consistency evaluation of generic drugs Will the pattern of pharmaceutical industry change dramatically? Many traditional Chinese medicine injection varieties have no bright spot, precise positioning, new adaptive population, high-end articles, expert consensus, big data, etc How to achieve variety value description and market pass through clinical re evaluation? How to improve the evaluation criteria in line with the characteristics of the product, accurately locate the dominant diseases, define the clinical optimal diagnosis and treatment scheme, and highlight the clinical value?