The number of innovative Chinese medicines approved in 2021 hits a record high, reaching 11

Compared with chemical drugs and biological drugs, traditional Chinese medicine has been difficult to innovate for a long time, and research and development generally face the problems of unclear mechanism of action and unclear active ingredients
.
In recent years, with the acceleration of Chinese medicine registration approval, Chinese medicine has ushered in innovative development, and the number of innovative Chinese medicines approved has continued to increase
.
Recently, information from the State Food and Drug Administration showed that the application for registration of Huzhen Qingfeng Capsules and Jieyu Chufan Capsules have been approved.
They are both innovative Chinese medicines developed on the basis of clinical experience and will provide new clinically relevant diseases for patients.
Treatment options
.
In November, the State Food and Drug Administration approved the application for the marketing of four innovative Chinese medicines: Yinqiao Qingre Tablets, Xuanqijiangu Tablets, Qizhi Yishen Capsules, and Kunxinning Granules
.
According to incomplete statistics in the industry, since 2021, the State Food and Drug Administration has approved a total of 11 innovative traditional Chinese medicines.
In addition to the above 6 products, there are also Qingfei Paidu Granules, Huashibaidu Granules, Xuanfei Granules approved in March.
Baidu granules; Yishen Yangxin Anshen tablets and Yiqi Tongqiao pills approved in September
.
This year is also the year when the number of innovative Chinese medicines approved in the past five years hit a record high
.
In September 2020, the "Registration Classification and Application Information Requirements for Chinese Medicines" issued by the State Food and Drug Administration clarified the classification criteria for registration of Chinese medicines, dividing Chinese medicines into innovative Chinese medicines, improved new Chinese medicines, ancient classic compound prescriptions, and same-named medicines with the same prescription.
These 4 categories
.
The new classification standard dilutes the content requirements of "effective ingredients" and "effective parts" in the original registration classification management, and no longer only uses the material basis as the basis for classification of registration categories, but supports the evaluation of the effectiveness of Chinese medicine based on the theory of Chinese medicine and clinical practice experience of Chinese medicine Sex, more emphasis on curative effect
.
At the same time, it is also required to establish a mechanism for evaluating Chinese medicine resources and strengthen the quality control of the whole process of Chinese medicine research and development
.
The industry believes that the clear classification of new registrations will bring about a substantial increase in the number of clinical applications and listings of new Chinese medicines
.
In order to encourage innovation in Chinese medicine, favorable policies are still issued this year
.
For example, on August 27, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guidelines for the Pharmaceutical Research of Chinese Medicine Compound Preparations Managed in the Catalogue of Ancient Classical Prescriptions (for Trial Implementation)", clarifying that the Chinese medicine compound preparations managed in accordance with the catalogue of ancient classic prescriptions belong to Chinese medicine registration classification 3.
1 (hereinafter referred to as Chinese medicine 3.
1)
.
The technical guidelines are formulated to better carry out the pharmaceutical research of Chinese medicine 3.
1 category
.
The technical guidelines mainly focus on the characteristics of the 3.
1 types of traditional Chinese medicines to elaborate the relevant requirements, and clarify the basic principles of the 3.
1 types of pharmacy researches of the traditional Chinese medicines.
The contents mainly include the research of medicinal materials, the research of decoction pieces, the research of reference samples, the research of preparation production, the research of preparation quality and quality standards, and the correlation.
aspects of research, research stability
.
Recently, Huajin Securities stated in a research report that the inflection point of the Chinese medicine policy has emerged, encouraging inheritance and innovation with a clear tone
.
The organization believes that Xintian Pharmaceutical focuses on innovative Chinese medicines, and in the research process, uses modern research methodology to conduct research, and the data can withstand the test
.
At the same time, the company has also forward-looking deployment of a medicinal material traceability system to control the quality of Chinese patent medicines at the source.
This report gives Xintian Pharmaceutical a buy rating
.
Fangde Securities analysis believes that the effect of leading Chinese medicine companies is significant, especially when the revitalization of Chinese medicine has become a national strategy in recent years, and the "Thirteenth Five-Year Plan" for the development of Chinese medicine has been issued successively, the Chinese medicine health industry market has gained rapid Growth, the industry has stepped into an accelerating growth channel
.
It is expected that the size of the Chinese patent medicine market will increase to approximately 1,137.
5 billion yuan by 2024, with a compound annual growth rate of approximately 6.
7%
.