Review of the development of traditional Chinese medicine in 2019

Wen Yancheng, he Bingyang In October 2019, the opinions on promoting the inheritance, innovation and development of traditional Chinese Medicine issued by the CPC Central Committee and the State Council once again raised traditional Chinese medicine to a national strategic level, following the implementation of policies such as the law of traditional Chinese medicine and the healthy China 2030 to encourage the development of traditional Chinese medicine industry In the field of traditional Chinese medicine, the diagnosis and treatment service industry of traditional Chinese medicine has developed rapidly, but the overall quality is uneven, and the operation mode and inheritance mechanism need to be innovated In the field of traditional Chinese medicine, although the state continues to issue a strategic plan to guide and encourage the development of traditional Chinese medicine industry, under a series of regulatory and control measures, such as drug supervision, medical insurance and health care, the industry of traditional Chinese medicine is in a state of obvious fatigue, the passing rate of new drugs on the market is almost zero, none of the traditional Chinese medicine preparations has passed the FDA approval, and the industry reshuffle is irreversible Traditional Chinese medicine is the great creation of the Chinese nation and the treasure of ancient Chinese science It has made an indelible contribution to the reproduction and health of the Chinese nation, as well as the contribution of the Chinese nation to the health of the people of the world The party and the government attach great importance to the work of traditional Chinese medicine, and have issued a series of documents, regulations and measures to revitalize the development of traditional Chinese medicine, providing three-dimensional policy support and financial support for the development of traditional Chinese medicine Under the favorable national policies, the Chinese medicine industry will usher in new opportunities for development Opinions on promoting the inheritance, innovation and development of traditional Chinese medicine (TCM) includes six aspects: improving TCM service system, giving full play to the unique role of TCM in maintaining and promoting people's health, vigorously promoting the quality improvement of TCM and the high-quality development of industry, strengthening the construction of TCM talent team, promoting the inheritance, opening, innovation and development of TCM, reforming and improving TCM management system and mechanism Twenty opinions were put forward, which gave a strong impetus to the development of traditional Chinese medicine All parts of the country are accelerating the high-quality development of traditional Chinese medicine and industry in accordance with the unified deployment of the Central Committee In November 2019, the national development and Reform Commission revised and issued the Guiding Catalogue of industrial structure adjustment (2019 version) In the field of traditional Chinese medicine, the contents of "inheritance and innovation of processing technology of traditional Chinese medicine pieces, development and production of traditional Chinese medicine famous prescriptions, research and development and production of innovative Chinese medicine drugs, efficient extraction equipment of traditional Chinese medicine, health care service of traditional Chinese medicine" are added to the catalogue Table 1 key policies in the field of traditional Chinese medicine in 2019 According to the latest statistical bulletin on the development of China's health and health undertakings in 2018, under the background of promoting the implementation of the registration system of TCM clinics, the number of TCM institutions increased significantly In 2018, the total number of TCM medical and health institutions in China reached 60738, an increase of 6495 compared with 2017 The expansion of TCM market demand and the outflow of prescriptions promoted the rapid development of TCM clinics By the end of 2018, 98.5% of the community health service centers, 87.2% of the community health service stations, 97.0% of the township hospitals and 69.0% of the village clinics in China had the ability to provide traditional Chinese medicine services The total number of traditional Chinese medicine health personnel in China was 715000, an increase of 7.7% over the previous year In 2018, the total number of people diagnosed and treated by Chinese medical and health institutions reached 1.07 billion, an increase of 5.2% over 2017 From the distribution of the number of patients, it is mainly concentrated in traditional Chinese medicine hospitals The proportion of patients in TCM clinics increased from 13.4% in 2017 to 14.0% Since the implementation of the Interim Measures for the record management of traditional Chinese medicine clinics in December 2017, traditional Chinese medicine clinics have entered a new stage of standardized growth In 2019, the key task division plan of the opinions of the CPC Central Committee and the State Council on promoting the inheritance and innovation of traditional Chinese medicine proposed to vigorously develop traditional Chinese medicine clinics, outpatient departments and special hospitals, and encourage chain operation Private TCM clinics are the mainstream trend of TCM clinic development In addition to the mature models such as comprehensive, health club, specialty and clinic drugstore, emerging formats such as TCM health center, TCM physiotherapy center, TCM Massage Center, TCM nursing home and TCM beauty salon are emerging The diversified development mode is helpful to explore the solutions to the core problems of traditional Chinese medicine clinics, such as low recognition of patients, lack of doctors' resources, and low qualification of clinics In recent years, the Chinese Medicine Museum has welcomed the policy and capital injection, and the Internet plus Chinese medicine platform such as Gu Sheng Tang, Jun He Tang, Jinhua Tuo has been continuously favored by the capital In 2019, Xiaolu medical center, an Internet platform for traditional Chinese medicine, received 20 million US dollars in pre-C rounds of financing, and Jinhua Tuo, a training platform for traditional Chinese medicine, received 10 million class a rounds of financing In 2018, the main business income of Chinese patent medicine production above designated size was 465.52 billion yuan, with a growth rate of 6.2%, the lowest in 8 sub industries of pharmaceutical industry; the total profit was 64.1 billion yuan, with a growth rate of only 3.8% The main business income of Chinese Herbal Pieces processing is 171.49 billion yuan, with a growth rate of 11.2%, slightly lower than the overall growth rate of the pharmaceutical industry of 12.7%; the total profit is 13.91 billion yuan, with a growth rate of 15.5%, higher than the overall growth rate of the pharmaceutical industry of 10.9% According to the output data of main industrial products of the National Bureau of statistics, the output of Chinese patent medicine decreased for two consecutive years in 2018 and 2019 According to the data of the General Administration of customs, in recent years, the export volume of traditional Chinese medicine has continued to decrease, and the export volume of traditional Chinese medicine has remained stable Compared with the whole traditional Chinese medicine industry, the overall operating revenue of listed enterprises is increasing, and the R & D investment intensity is increasing year by year In the first three quarters of 2019, the R & D expenses of Baiyunshan, Tianshili, Kangyuan pharmaceutical, China Resources Sanjiu and Yiling pharmaceutical were more than 200 million yuan, ranking the highest among Chinese medicine enterprises Traditional Chinese medicine enterprises, such as Tianshili and Kangyuan pharmaceutical, strengthen the research and development of traditional Chinese medicine products, increase the investment in the field of biological medicine and chemical medicine, and gradually form the coordinated development of traditional Chinese medicine, chemical medicine and biological medicine According to the data created by Huoshi, the investment and financing activities of traditional Chinese medicine enterprises showed an upward trend in 2015-2017, and suffered a precipitous decline in 2018 In 2019, the number of financing events decreased compared with that in 2018, and the financing amount increased (only based on the publicly disclosed data) The highest amount of investment and financing of TCM enterprises in 2019 was that Harbin Pharmaceutical Co., Ltd invested 971 million yuan in people's Tongtai and acquired 25.18% of the shares People's Tongtai is a wholesale and retailer of medicine, with main finished products covering traditional Chinese medicine, western medicine, health care products, etc In 2019, 470 new Chinese medicine enterprises and 174 pieces processing enterprises were added, with the number slightly lower than that in 2018 The number of new enterprises in the field of traditional Chinese medicine continued to decline after peaking in 2016 In 2019, the State Drug Administration approved two new 6 categories of traditional Chinese medicine, xiaoerjingxingzhike granules and shaoma Zhijing granules Since 2016, the State Drug Administration has only approved seven new traditional Chinese medicines, and the road of application and approval of new traditional Chinese medicines is extremely difficult Table 2 new Chinese medicine approved for market in 2016-2019 The second development of classical famous prescriptions and large varieties has become the main trend of traditional Chinese medicine innovation In 2018, the State Administration of traditional Chinese medicine and the drug administration successively issued the catalogue of ancient classic prescriptions (the first batch), the regulations on simplified registration and approval management of ancient classic prescriptions and traditional Chinese medicine compound preparations, which greatly accelerated the development of classic prescriptions In recent years, the approved new drugs Jinrong granules and Danlong oral liquid come from hospital preparations, Jiuwei Huanglian antidote ointment comes from TCM earthwork and university research and technology development, and the success of Jinhua Qinggan granules benefits from the government led scientific and technological project support under the clinical demand of influenza outbreak It can be seen from this that it is a prerequisite for the development of new Chinese medicine to have a definite and significant clinical effect And the inheritance of classics is an efficient channel to find clinical effective candidates, such as the development of hospital preparations, folk earthworks or reference to the listed famous prescriptions In 2019, CDE accepted 420 applications for traditional Chinese medicine, including 20 new drug applications, 3 generic drug applications and 1 import application The number of clinical trials of traditional Chinese medicine / natural medicine publicized for the first time is 80, which is higher than 48, 58 and 53 in 2016, 2017 and 2018; the number of phase II is the most, with 53, accounting for 66.25%; the number of phase I is 12, phase III is 9, and phase IV is 4 In 2018, the market scale of Chinese herbal pieces is about RMB 220 billion, of which, the proportion of Chinese herbal formula granules is about 8.4%, and the market scale is about RMB 18.5 billion The listed pharmaceutical enterprises with large sales scale of Chinese herbal pieces or Chinese herbal formula granules include Kangmei pharmaceutical, Chinese traditional medicine, HongRi pharmaceutical, Xiangxue pharmaceutical and Tailong pharmaceutical Among them, Kangmei pharmaceutical industry is the leader of Chinese herbal pieces, which has attracted much attention in 2019 due to the problem of "financial fraud"; Chinese herbal medicine is the leading enterprise in the market of Chinese herbal formula granules, with the revenue of formula granules exceeding 7 billion yuan in 2018 In December 2015, the former State Food and Drug Administration issued the measures for the management of traditional Chinese medicine formula granules (Draft for comments), strengthening the management of traditional Chinese medicine formula granules and guiding the healthy development of the industry Subsequently, Zhejiang, Jiangxi, Heilongjiang, Henan, Anhui, Guangdong, Hubei and other provinces successively issued documents At present, at least 10 provinces have issued relevant documents There are more than 60 enterprises nationwide that have obtained the pilot qualification of all kinds of traditional Chinese medicine formula granules In November 2019, the State Drug Administration issued the technical requirements for quality control and standard setting of traditional Chinese medicine formula granules (Draft for comments), which means that there are guidelines for the formulation of unified national standards for traditional Chinese medicine formula granules On the same day, the National Pharmacopoeia Committee issued the publicity on the unified standards for the pilot of traditional Chinese medicine formula granules, and published the unified standards for 160 varieties We will promote the construction of genuine production bases for traditional Chinese medicine and improve the quality and stability of raw materials for traditional Chinese medicine After the Hongmao liquor event in 2018, the core products of Bubu pharmaceutical fell into a storm in May 2019 due to the "useless theory" of traditional Chinese medicine injection, which once again caused widespread concern and Discussion on the efficacy and quality of traditional Chinese medicine Among the 1659 batches of unqualified drugs in the first half of 2019, there are 1187 batches of Chinese Herbal Pieces / herbs, accounting for 71.5% Chinese herbal medicines are still the most prominent problem in the domestic market Currently, the planting area of Chinese herbal medicines in China is nearly 100 million mu, the annual output is nearly 30 million tons, the supply exceeds the demand, and the quality varies greatly In December 2018, the construction plan of national authentic medicine production base (2018-2025) plans seven authentic medicine production areas, promotes the standardized cultivation of traditional Chinese medicine, and comprehensively improves the development level of traditional Chinese medicine industry The development mode of "Internet plus genuine medicinal materials" will be the key to promote the modernization of genuine medicinal materials By setting up an e-commerce base mode that integrates information services, electronic business, processing, storage, tracing, and standards, we can carry out a series of standardization work from planting, processing, warehousing to trade, logistics and other links "Customized Medicine Park" can effectively establish the traceability system of the whole process of Chinese medicine industry, encourage the cultivation of authentic medicine, ensure the quality of medicine, and help poor households to increase their income In 2019, Yunnan, Guizhou, Shaanxi, Heilongjiang and other places have issued policies, 11 of which are approved by Guizhou Province, 33 of which are approved by the first batch of Yunnan Province, and 32 of which are listed in the second batch In August 2019, the results of the fourth national survey of traditional Chinese medicine resources were announced The survey of traditional Chinese medicine resources has been carried out in more than 2000 counties of 31 provinces, cities and autonomous regions in China, and the information on the types and distribution of nearly 13000 kinds of wild medicinal resources has been collected, with a total of 20 million records More than 360000 samples of traditional Chinese medicine, wax leaf specimens and germplasm resources have been collected 79 new species have been found and preliminary analysis has been made Nearly 60% of them have potential medicinal value Improving the quality and adjusting the product structure are the main trends of the development of traditional Chinese medicine industry In recent years, the three competent departments of drug administration, health care and medical insurance have successively issued