The prospect of innovative traditional Chinese medicine is still optimistic

Not long ago, there was a general uptrend in the traditional Chinese medicine sector, a subdivision of innovative Chinese medicine drugs, which attracted much market attention
.
In 2021, both the speed of approval and the number of approvals for innovative traditional Chinese medicine drugs will hit a new high, and their future development space and prospects are generally optimistic by the market
.
From the perspective of the industry, behind the accelerated approval of innovative Chinese medicine drugs, in addition to the catalytic role of policies, there is also the support of industrial policies
.
During the "14th Five-Year Plan" period, the revitalization and development of traditional Chinese medicine has been raised to the national strategic level.
In the past two years, policies to support the innovative development of the traditional Chinese medicine industry have also been introduced
.
For example, in 2020, the State Food and Drug Administration issued the "Classification of Traditional Chinese Medicine Registration and Application Materials Requirements", which divided the registration of traditional Chinese medicines into four categories: innovative Chinese medicines (category 1), improved new Chinese medicines, classic prescriptions and drugs with the same name.
The registration classification of traditional Chinese medicines is oriented by clinical value, encourages the inheritance and innovation of traditional Chinese medicines, and further unleashes the innovation potential of traditional Chinese medicines
.
In February 2021, the "Several Policies and Measures on Accelerating the Development of Traditional Chinese Medicine Characteristics" pointed out that the reform of the review and approval mechanism of traditional Chinese medicines should be accelerated, and the evidence system of traditional Chinese medicine registration review and evaluation will be established with the "three combinations" of traditional Chinese medicine theory, human experience and clinical trials.

.
The "Measures" take the development of traditional Chinese medicine as the main line, and further strengthen the pertinence, objective and operability of the policy
.
On December 30, 2021, the State Administration of Traditional Chinese Medicine issued the "Guiding Opinions on Medical Insurance Supporting the Inheritance, Innovation and Development of Traditional Chinese Medicine", which increased the guarantee and support for the development of traditional Chinese medicine from the payment side
.
On January 5, 2021, the Center for Drug Evaluation of the State Food and Drug Administration issued the "Technical Guidelines for Communication and Exchange Based on the "Three Combinations" Registration Review Evidence System (Draft for Comment), which focuses on the theory of traditional Chinese medicine and human experience.
The new Chinese medicines developed under the traditional Chinese medicine registration review evidence system combined with clinical trials, propose the key nodes, meeting data requirements and concerns for clinical communication of different registration classifications, including human experience data
.
The continuous introduction of the above-mentioned measures fully reflects the country's strong support for the innovative development and high-quality development of the traditional Chinese medicine industry, and brings greater imagination to the development of innovative traditional Chinese medicine drugs.

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At present, the research and development of new Chinese medicines has ushered in a new development period, including Xintian Pharmaceutical, Jianmin Group, Pien Tze Huang, Taiji Group and other companies have many new Chinese medicine research projects
.
In addition, many Chinese medicine companies are also actively deploying on this track
.
For example, Conba’s 2021 semi-annual report revealed that it will actively promote the research and development of innovative drugs, especially major innovative traditional Chinese medicine botanical drug projects; Huluwa also said in its 2021 semi-annual report that it will strengthen the company’s pediatric traditional Chinese medicine innovative drugs and new varieties of projects
.
In addition, Fangsheng Pharmaceutical also stated to the relevant media not long ago that it will continue to increase investment in the research and development of innovative traditional Chinese medicine drugs
.
It is worth mentioning that innovative traditional Chinese medicine drugs mainly focus on meeting unmet clinical needs.
For new traditional Chinese medicine drugs under research, their indications, competing products, clinical progress, etc.
may all face challenges.
Therefore, innovative traditional Chinese medicine drugs are successfully launched.
Nor is it easy
.
The industry expects that innovative traditional Chinese medicine drugs will continue to expand in the future, and can be divided into two categories as a whole, one is innovation from scratch from 0 to 1, and the other is iterative, which may be from 1 to 2, 2 ~3 achieves step-by-step progression
.