Top 10 things to watch in the Chinese medicine industry in 2022!

On the first day of the stock market opening in 2022, the traditional Chinese medicine sector bucked the trend, with more than 20 traditional Chinese medicine companies' stocks trading at the daily limit
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This shows that the investment community's recognition of the Chinese medicine industry generally believes that 2022 will be a good year for the Chinese medicine industry
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In 2021, whether new drugs are approved or some policies are released, they are all developing in a favorable direction for the traditional Chinese medicine industry
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On this basis, how many surprises will 2022 bring us? 01.
Can the growth of the Chinese patent medicine market get rid of the decline in 2022? According to the data of Minet.
com, the terminal of Chinese patent medicine hospital was 272.
1 billion yuan in 2016, 281.
5 billion yuan in 2017, 283.
4 billion yuan in 2018, 278.
3 billion yuan in 2019, and 239.
8 billion yuan in 2020
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Although there is a high probability that the market size in 2021 will increase compared to 2020, it is expected to be difficult to return to the market size of 270 billion yuan
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The retail market size of Chinese patent medicine pharmacies was 99.
9 billion yuan in 2016, 107.
3 billion yuan in 2017, 111.
5 billion yuan in 2018, 111.
7 billion yuan in 2019, and 106.
7 billion yuan in 2020
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It is expected that the market size will be difficult to return to the level of 110 billion yuan in 2021, but it will increase compared with the market in 2020
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Regardless of the hospital terminal or the pharmacy retail market, 2021 is a year of trough recovery
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So, has the exploration of the market size of proprietary Chinese medicines come to an end? What products will the future development of proprietary Chinese medicines rely on? The new Chinese medicines approved in recent years, except for the new crown drugs, have failed to become "blockbusters"
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Can the new crown traditional Chinese medicine approved in 2021 achieve greater market returns in 2022 like the Lianhua Qingwen series of traditional Chinese medicines, new crown chemical drugs and vaccines? Still time to tell
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02.
What is the impact of the supplementation and withdrawal of provincial medical insurance on the Chinese patent medicine market? When the 2019 medical insurance catalogue was released, it was mentioned that the supplementary medical insurance catalogues of various provinces should be gradually eliminated within three years.

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Therefore, 2022 is the last year for the supplementary and withdrawal of medical insurance in various provinces.
It is expected that many Chinese patent medicines that have no new indications or have not entered the list of essential medicines for supplementary medical insurance may lose their access qualifications for medical insurance reimbursement, and the product market Scale will be greatly affected
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In the formal review of the medical insurance list in 2020, it belongs to the "drugs that have entered the latest version of the basic medical insurance drug list at the provincial level (inclusive) before December 31, 2019.

Among them, the main active ingredients are included in the "First Batch of National Key Drugs" There are a total of 174 proprietary Chinese medicines listed in the “Monitoring Rational Drug Catalog (Chemical Drugs and Biological Products)”, and basically none of them have entered the medical insurance catalog in 2021 and 2022.
These products are expected to face the loss of provincial medical insurance status after the market scale.
risk of decline
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03.
Access to the essential medicines list, opportunities for children's medicines, gynecological medicines, and male medicines? The way to enter the medical insurance, in addition to the new indications, there is also a list of essential medicines
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The list of essential medicines, which is changed every three years, was not released as scheduled in 2021 and is expected to be released in 2022
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If traditional Chinese medicine can enter the list of essential medicines, it is very likely to enter the list of medical insurance negotiation and thus enter the medical insurance
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This new list of essential medicines may make the list of children's medicines independent, which is an opportunity for traditional Chinese medicines for children's indications
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Due to the liberalization of the "three-child" policy, Chinese medicine for gynecology and andrology also has opportunities
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04.
Ethnic medicines, traditional Chinese medicine preparations in medical institutions, Chinese medicine decoction pieces and Chinese medicine formula granules will be included in the scope of the provincial supplementary catalogue The Guiding Opinions mentioned that qualified Chinese herbal decoction pieces, proprietary Chinese medicines, and Chinese medicine preparations in medical institutions should be included in the list of medical insurance drugs according to regulations
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According to the affordability of funds and clinical needs, all localities will include eligible ethnic medicines, TCM preparations and TCM decoction pieces in medical institutions into the scope of local medical insurance payment according to procedures, and establish a dynamic adjustment mechanism
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Include TCM decoction pieces that comply with the "Prescription Management Measures" and "Hospital TCM Decoction Pieces Management Regulations" but exceed the commonly prescribed doses prescribed in the "Pharmacopoeia" into the scope of medical insurance payment
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When the 2021 version of the medical insurance catalog was released, it was also mentioned that to "regulate the management of ethnic medicines, preparations in medical institutions, Chinese herbal decoction pieces and Chinese herbal formula granules", provincial medical insurance departments should follow the requirements of the "Interim Measures for the Administration of Medication for Basic Medical Insurance", improve procedures, Refine the standards, make scientific calculations, and include medicines that meet the conditions of clinical necessity, reasonable price, and exact curative effect into the scope of medical insurance payment
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Eligible regions can simultaneously determine the medical insurance payment standard
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It is necessary to establish a dynamic adjustment mechanism to timely transfer unqualified drugs out of the payment scope
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This is a policy that was not mentioned when the 2019 and 2020 Medicare Catalogs were released
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This means that ethnic medicines, TCM preparations in medical institutions, TCM decoction pieces and TCM formula granules are expected to be included in the provincial supplementary catalogue
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Xinjiang, Guangdong and other places have included traditional Chinese medicine formula granules into the management of the category B medical insurance catalogue, Guangdong, Hubei, Yunnan, Anhui and other places have issued the management measures (detailed rules) of traditional Chinese medicine formula granules, and clearly proposed that the varieties of traditional Chinese medicine formula granules should be managed according to the category B catalogue , online purchase
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The broken wall Chinese medicinal materials may also be included in the supplementary scope of provincial medical insurance
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05.
New Chinese patent medicines have been approved to a new high, and the wave of approvals is coming? In 2021, the number of new proprietary Chinese medicines has hit a record high, and 3 proprietary Chinese medicines have been approved for the treatment of new crowns.
Pien Tze Huang is responsible for the production) and Xuanfei Baidu Granules of Shandong Buchang
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Category 1 new drugs approved include Xuanqijiangu Tablets from Fangsheng in Hunan and Yinqiao Qingre Tablets from Kangyuan in Jiangsu
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The number of new TCM approvals in 2021 will still not exceed double digits, and the number of new drugs for production in 2021 will not exceed double digits
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In 2022, will the number of new TCM drug approvals exceed double digits? The author expects limited growth in the short term
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06.
Physicians who are not in the category of traditional Chinese medicine have systematically studied traditional Chinese medicine for one year.
What are the results? In 2019, when the National Health and Medical Commission released the National Key Monitoring Catalogue, it was mentioned that physicians who are not in the category of traditional Chinese medicine, after systematically learning the professional knowledge of traditional Chinese medicine for no less than one year and passing the assessment, follow the basic principles of syndrome differentiation and treatment in traditional Chinese medicine.
Chinese patent medicine prescription; those who have obtained a professional degree or degree in traditional Chinese medicine, integrated traditional Chinese and western medicine, or ethnic medicine approved by the educational administrative department at or above the provincial level, or have participated in a TCM training course for more than 2 years in western medicine approved by the provincial traditional Chinese medicine administrative department (total hours Not less than 850 hours) and obtained the corresponding certificate, or have studied Chinese medicine with a teacher for 3 years in accordance with the relevant provisions of the "Traditional Medicine Inheritance and Physician Qualification Examination Methods" and obtained the "Traditional Medicine Inheritance Certificate", both Prescriptions for proprietary Chinese medicines and Chinese herbal medicines can also be issued
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In 2022, it is expected that a group of physicians will complete a one-year systematic study of traditional Chinese medicine expertise and can prescribe Chinese patent medicines
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Will the increase in the number of prescribing physicians contribute to the practical application of Chinese and Western medicines in clinical practice and become a popularized experience and case? Worth watching
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07.
Will Classic Familiar products be launched in 2022? For the review that is compatible with the characteristics of ancient classic prescriptions, the State Administration of Traditional Chinese Medicine is currently preparing to establish an expert review committee composed of academicians of traditional Chinese medicine, masters of traditional Chinese medicine, and famous Chinese medicine practitioners in China to promote the implementation of simplified approval work
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In November 2020, the State Administration of Traditional Chinese Medicine and the State Drug Administration jointly issued the "Principles of Research on Key Information of Ancient Classic Famous Prescriptions" and "Key Information Table of Ancient Classic Famous Prescriptions (7 Prescriptions)"
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In the blink of an eye, a year has passed, and the biggest progress in ancient classic prescriptions is the "Technical Guidelines for Pharmaceutical Research of Traditional Chinese Medicine Compound Preparations Managed by the Catalogue of Ancient Classic Famous Prescriptions (Trial)" issued by the Drug Evaluation Center of the State Food and Drug Administration in August 2021 and "Guidelines for Writing Instructions for Traditional Chinese Medicine Compound Preparations (Trial)" issued in October 2021
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According to the requirements of stability studies, the validity period and storage conditions should be determined on the basis of the long-term stability test results of production-scale samples
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Under normal circumstances, 6-month accelerated stability test and 18-month long-term stability test research data should be provided when applying
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After the drug is put on the market, the stability test study should be continued
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Even if it can be declared like a chemical generic drug within 6 months, the quality research requirements "generally should conduct research and analysis on the quality of not less than 15 batches of medicinal materials in not less than 3 origins"
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Therefore, it is expected that the declaration of classic name formula products may not be available until the end of 2022
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08.
To what extent are Chinese patent medicines affected by disease-based payment? The "Guiding Opinions on Medical Insurance Supporting the Inheritance, Innovation and Development of Traditional Chinese Medicine" mentioned that priority should be given to the preferential treatment of traditional Chinese medicine issued by the state into the scope of payment by disease
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TCM medical institutions may not implement payment by disease diagnosis-related grouping (DRG) for the time being.
For areas that have implemented DRG and payment by disease score, appropriately increase the coefficient and score of TCM medical institutions and TCM disease types to fully reflect traditional Chinese medicine.
Service Features and Benefits
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This means that the use of proprietary Chinese medicines in TCM medical institutions temporarily does not need to worry about the impact of payment by disease
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However, Chinese patent medicine still has a very large group of medicines in the combination of Chinese and Western medicine prescribed by Western medicine
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If the treatment plan of western medicine does not include Chinese patent medicine, then Chinese patent medicine can only be considered to be paid by disease through the diagnosis and treatment plan of traditional Chinese and western medicine, which will have a greater impact on the use of Chinese patent medicine
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09.
Is the centralized procurement of proprietary Chinese medicines mainly in the form of regional alliances? In 2021, Hubei Province will take the lead in launching the regional alliance of Chinese patent medicines, and the average price of all products will be reduced by 41%
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The Guangdong Provincial Regional Alliance will be launched in early 2022
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Will the remaining provinces adopt the centralized procurement of Chinese patent medicines by referring to the prices of Guangdong Province and Hubei Province on a provincial basis, or will they initiate regional alliances? Still to be seen
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At present, the products of centralized procurement are mainly Chinese patent medicines with high sales, which are graded in a way related to the scale of use
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In the short term, the policy orientation is to promote the price reduction of Chinese patent medicines in the mainstream of the supply chain without affecting the overall marketing pattern.

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10.
With the full release of traditional Chinese medicine formula granules, will there be many competitors? Since November 1, 2021, the pilot program of traditional Chinese medicine formula granules, which has been implemented for more than 20 years, has ended
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At present, the market size of traditional Chinese medicine formula granules has exceeded 50 billion yuan, and the annual revenue of many companies that deploy traditional Chinese medicine formula granules is more than 1 billion yuan
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From the perspective of therapeutic field classification, the current largest application fields of traditional Chinese medicine formula granules are cold medicine and heat-clearing and detoxifying medicine, accounting for 18.
65% and 11.
13% of the market share respectively; followed by pediatric cold medicine and stomach medicine, accounting for 7.
17% and 6.
54% respectively.
market share
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There will be many spoilers entering the market for TCM formula granules, and it is expected that TCM formula particles will also face centralized procurement and unannounced inspections in the future
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How to ensure the quality of traditional Chinese medicine formula granules, but also have the cost advantage? Large-scale enterprises are expected to have more cost advantages
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