The first DAA was officially listed in China today, and the battle to "cure hepatitis C" is fully launched

Source: e drug manager 2017-07-27 global hepatitis C drug market has experienced a process of "rapid outbreak, rapid saturation and sharp contraction" in recent three years, which determines the great significance of rapid listing in the field of hepatitis C drug treatment for various pharmaceutical companies "On the 77th day after approval, Bristol Myers Squibb successfully launched the treatment plan of BLZ and swipe in China." Lin Taikang, President of Bristol Myers Squibb China, announced in Beijing on July 26 that "this joint program is the first and only all oral direct anti HCV (DAA) treatment program to be launched in China We hope to bring "cure hope" to millions of Chinese hepatitis C patients " The epoch-making significance of DAA treatment scheme for hepatitis C has been repeatedly proved There is no need to elaborate There are two other issues worthy of attention: who can take the lead and the availability of drug prices Now the race has been shot in the run-up phase, and BMS has completed the first successful DAA listing in China On April 24, CFDA approved the listing of Belize (dalatavir hydrochloride) combined with sullivir soft capsule in China, which is applicable to the treatment of adult gene 1b chronic hepatitis C (non cirrhosis or compensatory cirrhosis) According to BMS, as of July 25, drug supply has been realized in 121 hospitals and 548 drugstores across the country, including direct sales channels (DTP drugstores) covering patients across the country Speed up! Speed up! "This successful IPO created four firsts." Lin Taikang is very proud, "we are the first to complete phase III clinical trial in China, we are the first to be included in the priority review, we are the first to be approved and listed all oral DAA treatment program in China, and our first prescription was successfully issued on the 77th day after approval." In recent three years, the global hepatitis C drug market has experienced a process of "rapid outbreak, rapid saturation and sharp shrinkage", which determines the great significance of rapid listing in the field of hepatitis C drug treatment for various pharmaceutical companies Zhuang Hui, Professor of Peking University Medical Department and academician of the Chinese Academy of engineering, said: "the first all oral direct anti HCV drug is a landmark in the prevention and treatment of hepatitis C in China More Chinese hepatitis C patients are expected to get cure hope through innovative drugs with high cure rate, good safety and short treatment course, which makes it feasible to realize the vision of "eliminating hepatitis C" in China " The results of clinical study showed that the cure rate of BLZ combined with SVP was 91% - 99% In addition, BLZ has also been approved to be used in combination with other drugs, such as sophibuvir, for the treatment of adult full genotype (i.e genotype 1-6) chronic hepatitis C virus infection, which is also the only full oral combined treatment scheme recommended by China's hepatitis C prevention and control guidelines for the treatment of full genotype Data shows that there are about 10 million people infected with hepatitis C virus in China, and the number of newly reported cases of hepatitis C has increased from 21000 in 2003 (annually) to 230000 in 2016 (annually) But at the same time, the diagnostic rate of hepatitis C in China is only 2% The four first lists also reflect the fierce competition situation of multinational pharmaceutical enterprises and domestic pharmaceutical enterprises in the "DAA war" BMS is not alone The battle for hepatitis C "magic drug" sofibove came out, which made Gilead successfully become the top 10 Club of global pharmaceutical companies, and DAA treatment scheme has also become the globally recognized mainstream treatment scheme for hepatitis C; on the other hand, the pricing of sovaldi is also the social focus of the world in recent years According to the statistics of e drug managers, at present, there are 12 domestic and foreign drug companies whose hepatitis C drugs have been included in the priority review of CFDA; from October 2014 to February 2016, 24 domestic drug companies began to apply for clinical application in CFDA; following BMS, Geely De, Johnson & Johnson, MSD and Geli biology are expected to be approved as new hepatitis C drugs in China in the past two years At the 2017 APASL annual meeting held in February 2017, Gilead announced the phase III clinical trial data of sovaldi in China, BMS published the phase III clinical data of its combination of dalatavir hydrochloride and ashuribe soft capsule in the treatment of hepatitis C patients for the first time; Geli, a local pharmaceutical company, also published the phase III clinical data of its danoravir Clinical data results In addition, another market competitor, Aberdeen, also published the phase III clinical research data of the treatment of gene 1b chronic hepatitis C patients with obipali + dasebway ± ribavirin at the 67th Annual Meeting of the American Society for the study of liver diseases (AASLD) held in Boston, USA The products of these enterprises are all direct antiviral oral drugs, which can cure hepatitis C So who can win the big cake in the Chinese market? BMS's bottom line comes from two sources: the first is approved for listing, and its blockbuster product, boluting, has been in the Chinese hepatitis market for many years "In the process of China's medical reform, we have really felt the changes brought about by a series of recent measures of the Chinese government, such as accelerating the review and approval of innovative drugs." Lin Taikang said, "it is obvious that Bristol Myers Squibb is committed to the prevention and treatment of hepatitis in China Our hepatitis B antiviral drugs have benefited more than one million Chinese patients The successful approval of the joint treatment plan of BLZ and SVP once again confirmed the innovative R & D ability of Bristol Myers Squibb in the field of hepatitis, and fulfilled our commitment to actively promote the arrival of innovative drugs in China and help Chinese patients overcome hepatitis C " Pricing is a problem that almost all related pharmaceutical companies avoid In the United States, sovaldi has a course of treatment of US $84000; harvon has a course of treatment of US $94500, epclusa has a course of treatment of US $74500; in the other extreme, India, which strongly imitates sofibwe, has a course of treatment of US $840 Obviously in China, the middle of the two poles is the price range of the negotiation game for pharmaceutical companies, Chinese patients and Chinese medical insurance If we take 50000 yuan as a course of treatment and take 230000 newly reported hepatitis C patients in 2016 as a rough estimate, the current market size of hepatitis C drugs in China is about 11.5 billion yuan It is understood that based on the clinical demand for hepatitis C patients in China that is far from being met and full confidence in DAA drugs, a relevant pharmaceutical company has obtained a valuation of 3 billion yuan in the venture capital market with a DAA drug in phase II clinical It can be predicted that with the improvement of the diagnosis rate of hepatitis C, almost all pharmaceutical companies, including BMS, that develop DAA drugs, will be able to share a considerable market cake.