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Event: On October 9, Jiangsu Kangyuan Pharmaceutical's Class 3.
2 new Chinese medicine dispersion cold and wet granules was approved for marketing for epidemics caused by cold, dampness and depression
.
Counting the new crown "tripartite" granules approved last year, a total of 4 new Chinese medicine drugs of class 3.
2 have been approved for epidemic diseases
so far.
Throughout the regulatory history, the review and approval standards of traditional Chinese medicines have long applied chemical medicine standards, which do not conform to the law of Chinese medicine research and development, ignore the theoretical system of traditional Chinese medicine and the history of human experience, resulting in a series of problems such as a large number of approved traditional Chinese medicines such as lack of obvious advantages and insufficient innovation, which hinders the historical inheritance and modernization of the cause of
traditional Chinese medicine.
traditional Chinese medicine.
In recent years, the relevant improvements to the review and approval system for traditional Chinese medicines in China have accelerated, among which the hallmarks are:
· In 2020, the State Food and Drug Administration (NMPA) issued the Implementation Opinions on Promoting the Innovation and Development of Traditional Chinese Medicine, which pointed out that it would "improve the review and approval system that meets the characteristics of traditional Chinese medicine";
· Improve the review and approval system that meets the characteristics of traditional Chinese medicine · In 2021, the "Requirements for Registration Classification and Application Materials of Traditional Chinese Medicines", which fully considers the characteristics of traditional Chinese medicines, will classify the registration of traditional Chinese medicines according to innovative Chinese medicines, improved new drugs of traditional Chinese medicines, compound preparations of ancient classic Chinese medicines, and drugs with the same name and prescription, etc.
, and clarify that the first three categories belong to new Chinese medicines;
· In April 2022, the Center for Drug Review (CDE) of the State Food and Drug Administration issued the Guidelines for Communication and Exchange Based on the "Three Combinations" Registration Review Evidence System (Trial), and launched the review and approval standards
for traditional Chinese medicines based on the three-combination evidence system of "Chinese medicine theory-human experience-clinical trials".
With policy support, the innovation of traditional Chinese medicine has shown an accelerating trend, with only 19 new Chinese medicine drugs listed in the past five years, of which 12 were launched in 2021
.
The enthusiasm for R&D of Chinese medicine enterprises is high, and the R&D expenditure of Chinese medicine enterprises has been increasing in the past five years, exceeding 10 billion yuan in 2021, accounting for 3%
of revenue.
Table 1: New Chinese medicine drugs approved since 2021
Data source: CDE, compiled by Zhongkang Industry Research Center
Figure 1: R&D expenditure of A-share Chinese medicine enterprises from 2017 to 2021 (RMB 100 million)
Data source: Flush iFinD, compiled by Zhongkang Industry Research Center
In recent years, the number of applications for registration of traditional Chinese medicines has shown an upward trend, and the number of registration applications in 2021 has exploded, involving a total of 51 varieties, a year-on-year increase of 134.
8%; In 2021, the number of INDs filed increased significantly to 52, with as many as 368 supplementary applications
.
In terms of indications for clinical trials, new Chinese medicine drugs are mainly concentrated in five fields: neuropsychiatric, respiratory, digestive, cardiovascular and gynecology, and the number of neuropsychiatric and gynecological trials will grow rapidly in 2021, showing the diversification and expansion
of indications.
Figure 2: Number of applications accepted for registration of various categories of traditional Chinese medicines subject to technical review from 2017 to 2021
Figure 3: Distribution of indications for clinical trials of innovative Chinese medicines in 2021
Figure 2 and Figure 3 data source: NMPA "2021 Drug Evaluation Report", compiled by Zhongkang Industry Research Center
In addition, the linkage of multiple departments such as the Medical Insurance Bureau and CDE will bring more opportunities
for the development of new Chinese medicines.
When the national medical insurance drug catalogue was adjusted in 2021, 3 of the 67 new drugs negotiated were new Chinese medicine drugs
.
From the perspective of medical insurance payment, with the increase in the number of new Chinese medicine drugs included in the negotiation and the expansion of the radiation scope of medical institutions that can be used, it will drive the increase in demand.
From the perspective of the adjustment of the negotiation access price, all departments have fully considered the particularity of the development of traditional Chinese medicines, have a good negotiation pattern, and considering the continuous optimization of the evaluation of traditional Chinese medicines, it will give birth to the enthusiasm
for the research and development of innovative traditional Chinese medicines with clinical value.
brief summary
brief summary In the new era, Chinese medicine is facing a new development environment, and new Chinese medicine is shouldering the important responsibility
of inheriting the past and opening up the future.
With the paving of policies and systems, after years of accumulation and efforts, Chinese medicine enterprises have begun to enter the stage of realizing results, and the market of new Chinese medicines will continue to break out
in the future.
