The market of large varieties of traditional Chinese medicine injection is in crisis. How about the progress of enterprise re evaluation?

On June 11, the State Food and Drug Administration issued a notice, deciding to revise the instructions of Shuanghuanglian injection (Shuanghuanglian injection, Shuanghuanglian for injection (freeze dry), Shuanghuanglian powder injection), requiring the addition of warning words, and revising the items of [adverse reactions], [contraindications] and [precautions] Up to now, this year, we have issued three notices on the revision of the manual of traditional Chinese medicine injection (including Shenmai injection and Chaihu Injection), which is also the second traditional Chinese medicine injection required to revise the manual in half a month From the termination of Houttuynia injection in 2006 to the death of Shuanghuanglian Injection in 2009, to the elimination of Chuanshanlong injection and chaixin cold injection in 2012, traditional Chinese medicine injection has been controversial According to the annual report of national ADR monitoring (2017), in 2017, the proportion of injection and oral preparation was 54.6% and 37.6% respectively in the ADR / event report of traditional Chinese medicine, and the proportion of intravenous injection was relatively high in terms of the administration route involved in the serious report Traditional Chinese medicine injection, as a unique drug in our country, is widely used in clinical practice It is also the most "popular" and the fastest-growing compound drug category in hospital terminal in recent 20 years 　　 Data shows that from 1999 to 2006, the average annual growth rate of traditional Chinese medicine injection exceeded 30%, and the annual sales exceeded 20 billion yuan; among the top 10 varieties of traditional Chinese medicine in 2008, traditional Chinese medicine injection was exclusive of 6 kinds; according to the data of minenet, in 2016, the terminal traditional Chinese medicine injection in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) was completed The total size of the injection is over 104.8 billion yuan Such a huge market only benefits from the extensive growth of medical expenses The hundred billion scale industry of traditional Chinese medicine injection always lacks clear clinical data support of safety and effectiveness In recent years, we can find that most of the limited auxiliary drugs are actually traditional Chinese medicine injections The most common ones, such as Shenfu injection, Shenmai injection, Honghua injection, Dazhu Rhodiola injection, etc., are all monitored by many regions And combing the financial statements of listed pharmaceutical companies in 2017, 60% (18) of the 30 Chinese herbal injections with a market scale of more than 100 million had a significant decline in sales in 2017 Mailuoning injection of Jinling Pharmaceutical Co., Ltd declined the most, reaching 51.47%, and its sales scale shrank to 231 million yuan in 2017 On the one hand, due to the lack of clinical research and clinical data accumulation in domestic traditional Chinese medicine injection manufacturers, it is difficult to prove its safety and effectiveness; on the other hand, China has not strictly approved the listing of traditional Chinese medicine injection before Along with the frequent quality problems of traditional Chinese medicine injections, the safety of traditional Chinese medicine injections is questioned, and the re evaluation of traditional Chinese medicine injections is urgently put on the agenda (see Table 1) In April this year, there was a milestone event in the development of traditional Chinese medicine injection China Association of traditional Chinese medicine established a special committee for traditional Chinese medicine injection to jointly solve the research and development problems of enterprise varieties, and promote and implement relevant national policies and regulations In the same way, the re evaluation of traditional Chinese medicine injection has always been concerned by the industry, and many enterprises also hope to use traditional Chinese medicine injection to re evaluate the efficacy of self certification (see Table 2) For example, the Shenqi Fuzheng injection soft bag of Lizhu group is expected to be listed before the end of 2018, and has obtained the clinical approval of the United States, and is continuing to carry out the clinical research of Shenqi in the United States, and will also continue to carry out the post Market Research of the variety in China