Traditional Chinese medicine injection is on the cusp of the storm. Who can top 10 products last?

On the last day of the long National Day holiday, the document "opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices" (hereinafter referred to as "opinions") was jointly issued with super-high specifications of "two offices" The opinions not only mentioned the need to strictly review and approve the drug injection, but also stressed the need to strengthen the re evaluation of traditional Chinese medicine injection Wu Zhen, deputy director of CFDA, pointed out at a press conference the next day, "the most concerned injection is traditional Chinese medicine injection, because it is unique to China, but the disadvantage is that the data is not complete According to the requirements of No 44 document of the State Council, the safety of traditional Chinese medicine injections should be re evaluated The scheme has been preliminarily formed and may be consulted in the near future " Therefore, it is not difficult to imagine that, earlier, the 2017 edition of the highly watched medical insurance catalog increased restrictions on the use of some traditional Chinese medicine injections Just before the national day, CFDA recalled two famous traditional Chinese medicine injections, because they caused some patients to shiver, fever and other adverse reactions, one of which was detected to have unstable heat source A series of events once again pushed traditional Chinese medicine injection to the forefront of the wave So, what are the best-selling products in the market that will be affected? It is imperative to reevaluate traditional Chinese medicine injections What challenges will these best-selling products face next? None = "shifumousedownstyle ('shifu_bus_002 ')" style = "margin: 1em Auto; padding: 0px; max width: 100%; color: RGB (62, 62); font family:" hiragino sans GB "," Microsoft YaHei ", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; 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; "> Top 10 traditional Chinese medicine injections of public hospitals in key cities according to the data of minenet, the total sales volume of top 10 traditional Chinese medicine injections of public hospitals in key cities (Beijing, Guangzhou, Nanjing, Chongqing, Chengdu, Xi'an, Harbin, Shenyang, Zhengzhou) in the first half of 2017 is close to 3 billion yuan Ten products are concentrated in four treatment fields, including three for cardiovascular disease, three for tumor disease, two for clearing away heat and detoxification, and two for cerebrovascular disease The other 10 products are exclusive products except Shuxuening injection The data shows that in recent years, the growth rate of these 10 traditional Chinese medicine injections has declined in the same way In 2015, the growth rate of four products was once negative In 2016, the growth rate slightly recovered, but the momentum has been much lower than before   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; 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; "> the new medical insurance catalog was successfully launched, and many traditional Chinese medicine injections were limited In 2017, the new medical insurance catalog was finally published in February this year One of the highlights of this medical insurance catalog is to strongly support traditional Chinese medicine and ethnic medicine The proportion of Western medicine and Chinese patent medicine in the new catalog reached 51% and 49%, basically the same Chinese patent medicine has won the favor of medical insurance, but on the whole, oral traditional Chinese medicine preparations benefit more Traditional Chinese medicine injection is not only limited in the number of access, but also has new regulations in the scope of use Some of the best-selling products in the market are limited In the top 10 products of traditional Chinese medicine injections in public hospitals in key cities in the first half of 2017, except Xuebijing injection and Dazhu Hongjingtian injection failed to enter the new medical insurance catalog, the other eight products, although entering, are all related to the restrictions of medical institution level and disease type Huatai Securities once analyzed that the vast majority of heat clearing and detoxification, cardiovascular and cerebrovascular traditional Chinese medicine injection is limited to the use of hospitals above the second level, and the amount of grass-roots use will be greatly reduced Shi lichen, the founder of the third-party medical service system, once said that basic medical institutions are an important market for the sales of traditional Chinese medicine injections The new medical insurance catalog is bad news for the manufacturers of traditional Chinese medicine injections, and the sales of traditional Chinese medicine injections will be further affected in the future   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; 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; "> can re evaluation become a new vitality? On October 8, after the opinion was released to the full text of the society, CFDA held a press conference on October 9, and Wu Zhen, deputy director, interpreted it to the media; CFDA director Bi Jingquan made further arrangements on the document at the 10 th teleconference All actions were so close that the government departments attached great importance to the document Bijingquan mentioned that the consistency evaluation of the quality and efficacy of oral preparations has been carried out in an all-round way, and the re evaluation of injection is an important part of the quality and efficacy evaluation of generic drugs "To complete the evaluation of injection in 5-10 years is the task proposed in the opinions The opinion strictly limits the review and approval of injections For injections that have been approved for marketing in the past, the holders of approval documents are required to conduct research on ingredients, mechanism and clinical efficacy, and evaluate their safety, effectiveness and quality controllability " Under the pressure of "reassessment", is there only a dead end for traditional Chinese medicine injection? According to the analysis of Soochow securities, affected by the policy, the market of traditional Chinese medicine injection will further shrink in the future, but the product quality will become the key to success "Only by continuously carrying out clinical reevaluation and basic research of evidence-based medicine and achieving substantial results, can enterprises provide guarantee for products to be based on the market." This will be another war of survival of the fittest CFDA put the safety re evaluation of traditional Chinese medicine injection on the agenda as early as 2009, but there is no substantial progress due to various reasons In 2015, the State Council's opinions on reforming the review and approval system for pharmaceutical and medical devices also mentioned the need to actively promote the re evaluation of the safety of traditional Chinese medicine In the opinion, the safety re evaluation of traditional Chinese medicine injection was once again put in an important position Some people in the industry said that in the past ten years, too many once brilliant traditional Chinese medicine injections have failed in adverse reactions Now it is no longer an era that enterprises can survive by marketing methods and large amount of grass-roots market In the future, whether traditional Chinese medicine injection can survive in the increasingly strict policy environment and market environment depends on the safety and effectiveness of traditional Chinese medicine injection.