Blowout of innovative traditional Chinese medicine!

Innovative traditional Chinese medicine drugs are ushering in a period of opportunity.
In 2021, a total of 11 innovative traditional Chinese medicine drugs have been approved for listing, including Yinqiao Qingre Tablets, Xuanqi Jiangu Tablets, Qizhi Yishen Capsules, Kunxinning Granules, Qingfei Paidu Granules, Shibaidu Granules, Xuanfeibaidu Granules, Yishen Yangxin Anshen Tablets and Yiqi Tongqiao Pills,
etc.
In 2022, two innovative traditional Chinese medicines, Huzhen Qingfeng Capsule and Jieyu Chufan Capsule, have also been approved for marketing
.
Huaan Securities analysis believes that the approval and listing of new traditional Chinese medicine drugs will be accelerated in the future, and it is likely that there will be more than 20 per year
.
Behind the blowout of innovative traditional Chinese medicine drugs, policy support is inseparable
.
Among them, in terms of the application of innovative Chinese medicines, in September 2020, the State Food and Drug Administration issued the "Registration Classification of Chinese Medicines and Application Materials Requirements", which clarified the classification standards for registration of Chinese medicines, and divided Chinese medicines into innovative Chinese medicines, improved new Chinese medicines, and ancient classics.
There are 4 types of compound prescriptions with the same name and the same prescription with the same name
.
The new classification standard puts more emphasis on curative effect, and at the same time strengthens the quality control of the whole process of Chinese medicine research and development
.
After the release of this document, it is conducive to the development of the traditional Chinese medicine industry in the direction of innovation
.
In terms of traditional Chinese medicine review, in January 2021, the "Notice on Several Policies for Accelerating the Development of Traditional Chinese Medicine Characteristics" pointed out that it is necessary to optimize the management of traditional Chinese medicine review, strengthen inter-departmental linkage, recommend new traditional Chinese medicines that meet the requirements to be included in the fast review channel, increase Number of third-party registration and inspection institutions for new Chinese medicines
.
In order to support the innovation of traditional Chinese medicine, on August 27, 2021, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guidelines for Pharmaceutical Research of Traditional Chinese Medicine Compound Preparations Managed by the Catalogue of Ancient Classic Famous Prescriptions (Trial)", which clearly stated that the management should be carried out according to the catalogue of ancient classic prescriptions.
The traditional Chinese medicine compound preparation belongs to the category 3.
1 of the traditional Chinese medicine registration classification
.
The purpose of formulating this technical guideline is to better carry out the pharmacy research of TCM 3.
1
.
The technical guidelines mainly focus on the characteristics of Category 3.
1 of traditional Chinese medicine to elaborate the relevant requirements, and clarify the basic principles of pharmaceutical research of Category 3.
1 of traditional Chinese medicine.
Research, stability research, etc.

.
In December 2021, the "Guiding Opinions on Medical Insurance Supporting the Inheritance, Innovation and Development of Traditional Chinese Medicine" was released, pointing out that it is necessary to give full play to the advantages of medical insurance to support the innovation, inheritance and development of traditional Chinese medicine, expand the radiation capacity of traditional Chinese medicine medical institutions, and formulate payment policies that conform to the laws of traditional Chinese medicine
.
In addition, in 2021, a series of important policies will be implemented, such as the end of the pilot program of traditional Chinese medicine formula granules, the moderate price reduction of centralized procurement of traditional Chinese medicine in Hubei, and the guidance of medical insurance to support the inheritance, innovation and development of traditional Chinese medicine.
Strong positive signal
.
Under a series of favorable policies, many securities institutions expressed their optimism about the development of innovative Chinese medicines
.
For example, Huajin Securities pointed out in the research report that the inflection point of traditional Chinese medicine policy has emerged, and the tone of encouraging inheritance and innovation is clear
.
In the view of Debon Securities, Chinese patent medicine has unique advantages in the treatment of intractable diseases and chronic diseases, and its application has the attributes of multi-field growth
.
In the future, with the promotion and application of more innovative traditional Chinese medicines with clinical evidence-based medicine value, the space is expected to be further opened up
.
For example, in the field of respiratory diseases, Chinese patent medicines have good prospects in the respiratory disease market and are expected to exceed 100 billion yuan in 2026, while innovative Chinese medicines will gradually play an important role
.