[exclusive] 100 billion market enters the life and death situation, panoramic analysis of traditional Chinese medicine injection

In China's drug market, in addition to chemical drugs, there are also Chinese patent medicines with Chinese characteristics Among Chinese patent medicines, traditional Chinese medicine injection, as a modern product, has always been the most concerned According to data statistics, in 2016, the market size of traditional Chinese medicine injection has exceeded 100 billion However, from the market feedback in recent years, traditional Chinese medicine injection has repeatedly fallen into the situation of continuous questioning The chain reaction caused by the recent step pharmaceutical event, and the discussion of Wang Zhian, a media man, on traditional Chinese medicine injection, have even pushed traditional Chinese medicine injection into the hot topic of the industry Nearly 80 years of development, 1977 Pharmacopoeia included the peak, 2006 declaration decline since 1940, the first Chinese medicine injection Chaihu Injection, to now, nearly 80 years In the early days of the founding of the people's Republic of China, drug regulation was not perfect, and a large number of "new drugs" emerged due to the chaotic situation of running drug factories and abusing drugs At this time, a large number of traditional Chinese medicine injections began to be developed The 1953 edition of Chinese Pharmacopoeia did not include traditional Chinese medicine injections By 1963, there were 4 kinds of injections included in the chemical part, while the 1977 edition of Chinese Pharmacopoeia included 24 kinds of traditional Chinese medicine injections, which was the peak of the collection In the follow-up development, along with our country drug registration system to legalization Many versions of the measures for the approval of new drugs and the measures for the administration of drug registration have been issued, and the administration of the application of traditional Chinese medicine injections has been revised for many times In the 1992 and 1999 versions of the measures for the approval of new drugs, the traditional Chinese medicine injections were listed as class 2 in the registration, and then in the 2002 version of the measures for the administration of drug registration, class 7: "injections made of traditional Chinese medicine and natural drugs not marketed in China In 2005 version, the 7th description of 2002 version was cancelled, indicating that the drug evaluation department in China is gradually strict and cautious in the management of traditional Chinese medicine injection, and the development of traditional Chinese medicine injection is sharply reduced In particular, the decline of new drugs for traditional Chinese medicine injection is particularly severe, and there is no new drug application in 2017, 2018 and 2019 The adverse reactions remain high and the use of medical insurance is limited The challenge is only to start the "Houttuynia injection incident" in 2006, which caused a sensation in the industry Since then, the adverse reactions of traditional Chinese medicine injection have been paid attention to According to the monitoring feedback of the State Food and Drug Administration on adverse drug reactions in the past five years, although the proportion of traditional Chinese medicine and traditional Chinese medicine injection in the overall adverse reactions is basically stable, the proportion of traditional Chinese medicine injection in the overall traditional Chinese medicine is more than 50%, and there is a small increase in the past three years Compared with other commonly used dosage forms, the adverse reactions have been in a high position, and the improvement of adverse reactions is not obvious In view of the market feedback of traditional Chinese medicine injection, the state has taken measures to manage it from various aspects The instruction manual has been revised for many times, including xiaochanping injection, Shuanghuanglian injection, Qingkailing injection, Shenmai injection, Ciwujia injection, Xuesaitong injection, Shuxuetong injection, Chaihu Injection, Yinzhihuang injection, Breviscapine injection, Shuxuening injection, Houttuynia injection, Xingnaojing injection, Notoginsenoside injection, astragalus injection, danxiangguanxin injection, goldfish injection , compound dandelion injection, Lianbizhi injection, Chuanhuning Injection, etc., among which there are many restrictions on children and pregnant women In addition to the instructions, the 2017 medical insurance catalog restricts the use of 38 traditional Chinese medicine injections, as shown below The limitation of medical insurance is only the beginning In December 2018, the national health and Health Commission issued the notice on the management of clinical application of auxiliary drugs, emphasizing that the national auxiliary drugs catalogue will be formulated and published On the basis of the national version, each province will formulate the provincial auxiliary drugs catalogue respectively, and the varieties of the provincial catalogue shall not be less than the national catalogue At the same time, the proportion of auxiliary drug income is listed as the assessment content of the third level public hospitals When drugs enter the catalogue of auxiliary drugs, they will face the risk of being strictly controlled or even stopped by public hospitals Prior to that, in the case of local auxiliary drug catalog, the number of traditional Chinese medicine injections was prominent In reference to local conditions, the national auxiliary drug catalog of traditional Chinese medicine injections had a high voice In addition to the crisis of auxiliary drug catalog, the use of traditional Chinese medicine injections is also facing restrictions in the basic drug catalog For example, in April 2019, the Hunan Pharmaceutical centralized purchase platform issued the notice on adjusting the use of some basic drugs in primary medical institutions, which eliminated traditional Chinese medicine injections from primary medical institutions In fact, there are 10 traditional Chinese medicine injections in the basic medicine catalog, and the two consecutive versions are on top of the list, of which 6 varieties have sold more than 100 million and 3 products have sold more than 1 billion In addition to Chaihu Injection, the other nine drugs are still limited in the use of medical insurance If the grass-roots level is not included in the use trend, it will face a greater blow and the road ahead is worrying The enterprises mainly engaged in traditional Chinese medicine injection have experienced the test of life and death in the current environment From the perspective of some listed enterprises, the performance has begun to be affected For example, in 2018, the injection business revenue of Kangyuan Pharmaceutical Co., Ltd was 1.991 billion, up 17.75% year-on-year, but the gross profit rate decreased by 0.25% Shenwei pharmaceutical reported a 21.4% drop in injection revenue in its first quarter 2019 annual report In addition, China Resources Sanjiu, Dali pharmaceutical and Zhongheng group all indicated in the annual report that the important injection business was declining We have insight into the current product pattern, strategic upgrading, and meet the great changes in the database of drug screening system for intelligent drug listing At present, there are 947 approvals (including injection and powder injection) for traditional Chinese medicine injection in the domestic market, involving 132 drugs and 217 enterprises The top 10 enterprises holding injection approval documents and varieties are shown in the figure below The top 10 enterprises hold 249 approval documents in total, accounting for 26.3% of the total approval documents Shenwei Pharmaceutical Group holds the most approval documents for traditional Chinese medicine injection, followed by China Resources 39 Among the top 10 enterprises holding varieties, Shenwei Pharmaceutical Group and Wanrong pharmaceutical of langzhi group rank first, followed by Jiangxi tianshikang traditional Chinese medicine and leiyunshang Pharmaceutical Group In addition, the varieties with more production approval documents are Xiangdan injection, involving 65 enterprises holding production approval documents; Houttuynia injection, involving 54 enterprises holding production approval documents; Chaihu Injection, 69 enterprises holding production approval documents However, there are more than 10% of the existing injections in the four fields of blood and hematopoietic organs, respiratory system, digestive tract, metabolism and cardiovascular system According to the approval documents, respiratory system injection has the most approval documents, accounting for 26.1%, followed by blood and hematopoietic organs, accounting for 25.3%; cardiovascular system, accounting for 15.6%, followed by digestive tract and metabolism, accounting for 12.7% In the face of life and death of traditional Chinese medicine injection, enterprises need to understand the overall situation of the market, start a new strategic layout, in order to go long-term At the national level, the re evaluation of traditional Chinese medicine injections is on the one hand, such as Kangyuan pharmaceutical industry, two major injection varieties have started the re evaluation work; on the other hand, the adjustment of product structure is on the other hand, such as China Resources Sanjiu After several years of gradual adjustment, the proportion of traditional Chinese medicine injections, which used to account for a large proportion of prescription drug business, has gradually declined in the business income In the 2018 annual report, the proportion of traditional Chinese medicine injections in the business is The proportion of industrial income is about 7% Data source: Yao Zhi data statement: This article only represents the author, not the position of Yao Zhi Com Welcome to exchange and supplement in the message area If you need to 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