The policy of speeding up the evaluation of new traditional Chinese medicines has detonated the market conditions, and the battle for innovative resources of traditional Chinese medicines has begun!

In the negotiation of medical insurance renewal, the decline of Chinese patent medicine was more moderate
.

On the medical insurance payment side, the payment for traditional Chinese medicine will be clearer in the future

The "Guiding Opinions of the National Medical Security Administration and the State Administration of Traditional Chinese Medicine on Medical Insurance Supporting the Inheritance, Innovation and Development of Traditional Chinese Medicine" is one of the important factors that will detonate the performance of the entire traditional Chinese medicine industry in the secondary market by the end of 2021 and early 2022
.

On February 21, 2022, at the New Year Outlook Conference of China's Pharmaceutical Industry hosted by E-pharmaceutical managers, Tan Guochao, chief pharmaceutical analyst of Huaan Securities, gave an in-depth report on "Innovative Traditional Chinese Medicine: Riding the Wave of the Times, the Dawn of Innovative Traditional Chinese Medicine" shared
.

The report expounds the innovative development of traditional Chinese medicine from the aspects of policy, payment, declaration, approval, and clinical practice

01.
The policy is gradually clarified, detonating the market of traditional Chinese medicine

01.
The policy is gradually clarified, detonating the market of traditional Chinese medicine

Looking at the policy release process of traditional Chinese medicine, Tan Guochao said that 2019 is a relatively important year, and the "Opinions on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine" was issued, which laid a policy foundation for the innovation of traditional Chinese medicine in the country in the future
.

From 2020 to 2021, the support policies for innovative Chinese medicine drugs will continue to be implemented
.

During this period, the State Food and Drug Administration has clearly classified the registration of traditional Chinese medicines

Tan Guochao said that the key to making traditional Chinese medicine attract widespread attention at the end of 2021 and the beginning of 2022 is that on December 30, 2021, the National Medical Insurance Administration and the State Administration of Traditional Chinese Medicine issued the "National Medical Insurance Administration and the State Administration of Traditional Chinese Medicine".
Guiding Opinions on Medical Insurance Supporting the Inheritance, Innovation and Development of Traditional Chinese Medicine" (hereinafter referred to as "Opinions")
.

Tan Guochao pointed out in his sharing that this document is one of the important factors that detonated the performance of the entire traditional Chinese medicine industry in the secondary market, and the "Opinions" gave more support to traditional Chinese medicine
.

The "Opinions" have made a relatively clear implementation of the inheritance of traditional Chinese medicine from the perspective of medical insurance, including including qualified medical institutions of traditional Chinese medicine into the designated medical insurance, and managing the price of medical services of traditional Chinese medicine, simplifying the approval procedures for new price items, and opening up some green channels
.

Tan Guochao emphasized that what is worth paying attention to is that public medical institutions purchase Chinese herbal decoction pieces from formal channels, and sell them strictly according to the actual purchase price, which does not exceed 25%
.

Tan Guochao introduced that some traditional Chinese medicine and traditional Chinese medicine medical services have not been clearly included in the medical insurance program before, but in this "Opinion", Chinese patent medicines and traditional Chinese medicine preparations will be included in the medical insurance catalogue according to regulations, and will also be negotiated by the national medical insurance.
, they are included in the medical insurance catalog, and they are more directly regulated by the state
.

And in the "Opinions", it is also proposed that TCM medical institutions can temporarily not charge and pay according to DRG

At the beginning of 2022, CDE released the technical guidelines for communication and communication (draft for comments) under the registration review evidence system based on the "three combinations (traditional Chinese medicine theory, human experience, and clinical trials)"
.

This principle is based on the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine" issued in October 2019, which proposes to "build a traditional Chinese medicine registration review evidence system that combines traditional Chinese medicine theory, human experience and clinical trials".

In addition, CDE has also issued guidelines for the toxicology research of new Chinese medicines, which have made relatively clear regulations and researches on the clinical registration of innovative Chinese medicines and the subsequent pharmacology
.

The policy has also gradually liberalized the prescription rights of non-Chinese medicine practitioners

In terms of internationalization, the country also hopes to use the "One Belt, One Road" path to promote the international development of traditional Chinese medicine, and hopes to create 10 overseas cultural communication projects of traditional Chinese medicine, 50 international cooperation bases for traditional Chinese medicine, etc.
, all of which are It is the state's policy support for traditional Chinese medicine
.

02.
The price reduction in the negotiation of medical insurance renewal is more moderate, and the advantages of the payment side appear

02.
The price reduction in the negotiation of medical insurance renewal is more moderate, and the advantages of the payment side appear

On the payment side, in the medical insurance negotiation from 2017 to 2021, the advantages of traditional Chinese medicine have gradually emerged
.

The data shows that from 2017 to 2020, the proportion of traditional Chinese medicines included in medical insurance has been increasing year by year
.

At the same time, the TCM policy released in December 2021 provides guidance on TCM institutions and the inclusion of TCM medicines in medical insurance, etc.

In terms of supervision, establishing and improving a system that adapts to the characteristics of traditional Chinese medicine services is also one of the priorities of the "Opinions"
.

On the whole, the support of the payment side for traditional Chinese medicine has been gradually strengthened

In addition, in terms of the decline in the continued bid, the decline in traditional Chinese medicine was relatively moderate
.
For example, in the following 23 products "renewed in the medical insurance negotiation in 2021", only 5 products have price cuts, and the prices of other products are basically flat
.

Among them, only Shenwei Pharmaceutical's Qihuang Tongmi Soft Capsules fell by more than 10% to 12.
86%, and the price of Shanghai Kaibao's Tanreqing Capsules fell by 3.
89%
.

Previously, most of the approved categories of traditional Chinese medicine belonged to the medical insurance category B.
Tan Guochao said that he believed that with the advancement of traditional Chinese medicine innovation and the increase of national support, it is believed that innovative traditional Chinese medicine drugs will be covered by medical insurance, how to reimburse them, and the later medical insurance negotiation.
, there will definitely be a more definite plan, which is worth looking forward to
.

03.
Respect the characteristics of traditional Chinese medicine, and make the approval and registration more detailed

03.
Respect the characteristics of traditional Chinese medicine, and make the approval and registration more detailed

On the approval side of traditional Chinese medicine, a total of 20 innovative traditional Chinese medicines have been approved from 2017 to 2021, but a total of 12 new traditional Chinese medicines have been approved in 2021, which means that only 8 new traditional Chinese medicines have been approved from 2017 to 2020
.

Behind the change in this figure is the further clarification and refinement of the classification of new Chinese medicines by the state
.

Tan Guochao said that 2007 and 2020 are two relatively clear time points, and the registration classification of traditional Chinese medicines has been continuously simplified, and innovative traditional Chinese medicines are listed separately
.

In 2007, the registration classification of traditional Chinese medicines was relatively rough, but in the 2020 drug registration management measures,

Innovative traditional Chinese medicine drugs are more clarified, specifically referring to the new prescriptions of traditional Chinese medicines that are not listed in the national drug standards, drug registration standards and the "Catalogue of Ancient Classic Famous Prescriptions" issued by the national Chinese medicine authority, have clinical value, and are not listed overseas.
preparation
.

The improved new drugs of traditional Chinese medicine have also been clarified, which refers to changing the administration route and dosage form of the listed traditional Chinese medicine, and has

Advantages and characteristics of clinical application, or preparations with added functions and indications
.

The ancient classic and famous traditional Chinese medicine compound preparations have also been clarified, referring to the prescriptions recorded in ancient Chinese medicine classics with obvious characteristics and advantages, which are in line with the provisions of the "Chinese Medicine Law of the People's Republic of China", are still widely used, have definite curative effects, and have obvious characteristics and advantages
.
The traditional Chinese medicine compound preparations of ancient classic prescriptions refer to the traditional Chinese medicine compound preparations derived from ancient classical famous prescriptions
.

"The registration classification of traditional Chinese medicine in 2020 not only takes into account the characteristics of traditional Chinese medicine, but also pays attention to inheritance, and also combines the factors of traditional Chinese medicine innovation, with more emphasis on clinical value.
" Based on clinical experience, this makes a big difference
.

The classification of traditional Chinese medicine registration has become clearer.
At present, the application materials of new drugs are also given some reduction and exemption policies for the registration of some traditional Chinese medicines
.
For example, some traditional Chinese medicine preparations that have been used by people can be effective according to human experience, and pharmacodynamic experiments can be appropriately reduced
.
In addition, some drugs with increased functions can also reduce some experiments based on human experience, and the same is true for ethics.
"However, we must communicate and communicate with the drug regulatory department in advance," Tan Guochao suggested
.
On the whole, the registration of traditional Chinese medicines pays more attention to real-world research.
For example, the Hainan Key Laboratory of Real-world Data Research and Evaluation of the State Food and Drug Administration was officially completed, which is also a great benefit for innovative traditional Chinese medicine products
.

04.
The launch of new traditional Chinese medicine drugs is accelerating, and the trend of traditional Chinese medicine innovation is good

04.
The launch of new traditional Chinese medicine drugs is accelerating, and the trend of traditional Chinese medicine innovation is good

Judging from the results of the above policies, the speed of approval of new Chinese medicines has "accelerated, and the acceleration is particularly fast", Tan Guochao said in his speech
.

Historical data shows that in 2017, the approval of an innovative traditional Chinese medicine drug even took 3,600 days.
In 2018, it was shortened to less than 2,000 days.
In 2021, the acceleration trend is more obvious, and most of them can be approved for marketing in 300 days
.
Time to market has been reduced by 90%
.
And the new anti-cancer drug icariin soft capsule, which was approved for marketing in 2022, was approved for marketing in less than 300 days
.

Tan Guochao said that in the future, the speed of approval and listing of innovative Chinese medicine drugs will be further shortened.
At this speed, it is predicted that in the next few years, the number of new Chinese medicine drugs approved each year will not be less than 12 in 2021
.

The data shows that the innovation trend of traditional Chinese medicine is good
.
From 2016 to 2021, a total of 191 clinical projects have been applied for, and the number of clinical applications has increased year by year in the past three years.
In 2021, the proportion of clinical applications for innovative Chinese medicine drugs will be 65%, which is twice that of 2020 and about 5 times that of 2019
.
The proportion of improved traditional Chinese medicine, compound preparations, and same-name and same-prescription drugs tends to decrease
.

From 2016 to 2021, a total of 399 clinical trials were declared, of which digestive system diseases, infectious diseases, circulatory system diseases, and respiratory system diseases accounted for a relatively high proportion
.
A total of 82 applications will be submitted in 2021, of which digestive system diseases, circulatory system diseases, and infectious diseases still account for a large proportion
.

From 2014 to 2021, a total of 905 clinical studies related to traditional Chinese medicine were carried out in China, of which the establishment of a large number of clinical trials from 2014 to 2015 laid a solid foundation for the follow-up clinical development of traditional Chinese medicine
.
In the past three years, with the wave of innovative drugs, the proportion of Phase III clinical trials of traditional Chinese medicine has gradually increased, the number of non-standard staging studies has gradually decreased, the trend of early scientific research transformation has been good, and the evidence of evidence-based medicine has been continuously enriched
.

Regarding the future of Chinese medicine innovation, Tan Guochao said in his speech that in the next 3-5 years, Chinese medicine innovation will enter an era of chaotic competition for resources
.
Companies and investment institutions will definitely try their best to find companies that have the ability to transform and purify traditional Chinese medicine.
Each company and institution will actively strive for cooperation with traditional Chinese medicine medical institutions and universities of traditional Chinese medicine, and put better traditional Chinese medicines and patents.
Grab your hands
.
In the next few years, the basic policies for the innovation and development of traditional Chinese medicine will continue to be implemented.
In the future, traditional Chinese medicine enterprises will have the opportunity to resonate with the development of the industry and policies
.
Looking forward to the future of innovative Chinese medicine drugs, the innovation system that has been built in domestic western medicine can be taken to a higher level, not only in the domestic market, but also in the international market
.