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In recent years, under the promotion of favorable policies, innovative traditional Chinese medicine drugs are rapidly being produced
.
According to the data, among the 1,439 domestic Class 1 innovative drug registration applications accepted by CDE in 2021, the number of Chinese medicine applications has reached a new high
.
Specifically, as of December 31, 2021, the CDE Review Center has accepted a total of 11,569 acceptance numbers (data statistics are as of December 31, 2021, the same below), and the number of clinical applications and production applications is compared with 2020.
Significant improvement, including 2,452 acceptance numbers for clinical applications and 2,157 acceptance numbers for production applications
.
Among these declared drugs, there are 1,439 domestic Class 1 innovative drug registration applications, 1,383 clinical applications and 52 marketing applications
.
According to the statistics of drug types, there are 896 chemical drugs, 489 biological products (including 481 biological products for treatment), and 54 traditional Chinese medicines
.
It is understood that due to the influence of its own drug characteristics, the application of traditional Chinese medicine has always been in a relatively sluggish state, but the number of traditional Chinese medicine applications in 2021 has increased significantly
.
In this regard, the industry believes that this is inseparable from the help of policies
.
It is reported that in recent years, China has issued a series of policies and measures around the inheritance, innovation and development of traditional Chinese medicine
.
Among them, since the release and implementation of a series of documents such as the newly revised "Administrative Measures for Drug Registration" and "Requirements for Registration Classification and Application Materials of Traditional Chinese Medicines", the innovation vitality and potential of traditional Chinese medicines have been continuously released, and the enthusiasm for research and development of new traditional Chinese medicines has increased greatly and has been approved.
The number is also growing
.
The industry predicts that, according to the current industry trend, in 2022, the innovation vitality and potential of traditional Chinese medicine will continue to be released, and new approved drugs will continue to emerge
.
In fact, a number of new traditional Chinese medicines have been launched this year.
For example, on January 10, the State Food and Drug Administration announced that the State Food and Drug Administration recently approved the 1.
2-type innovative drug Epimedium with conditions through the priority review and approval process.
Vegetarian soft capsules were launched
.
This is the first innovative traditional Chinese medicine drug approved for marketing in my country since 2022
.
On January 4, Jianmin Group also issued an announcement saying that the 1.
1 class innovative traditional Chinese medicine Qirui Weishu Capsule was approved for marketing, which is used for mild to moderate chronic non-atrophic gastritis with erosive damp-heat stasis syndrome caused by epigastric pain, tongue Dark purple or ecchymosis petechiae, yellow and greasy tongue coating, stringy or slippery pulse
.
It is worth noting that, in addition to the continuous increase in the number of innovative traditional Chinese medicine drugs, there are actually data showing that the traditional Chinese medicine manufacturing market is also expanding.
From 2016 to 2020, China's traditional Chinese medicine manufacturing market has increased from 63.
7 billion yuan to 73.
7 billion yuan, with a compound annual growth rate of 3.
7%
.
According to this trend, the industry predicts that by 2025, the market size may reach 4,807.
17 billion yuan
.
In general, policy support plays an important role in promoting the development of the traditional Chinese medicine industry
.
Therefore, under the influence of a series of favorable policies and the improvement of review and approval efficiency, the research and development of new Chinese medicines is expected to enter a period of rapid development
.
In this context, more and more traditional Chinese medicine companies are expected to focus on the development of new drugs
.
In this regard, the industry suggested that future research can focus on the strength of strong, modern innovation the subject of major categories of traditional Chinese medicine layout; and benefit from consumption upgrade, extend the industrial chain focus, strong brand subject
.
.
According to the data, among the 1,439 domestic Class 1 innovative drug registration applications accepted by CDE in 2021, the number of Chinese medicine applications has reached a new high
.
Specifically, as of December 31, 2021, the CDE Review Center has accepted a total of 11,569 acceptance numbers (data statistics are as of December 31, 2021, the same below), and the number of clinical applications and production applications is compared with 2020.
Significant improvement, including 2,452 acceptance numbers for clinical applications and 2,157 acceptance numbers for production applications
.
Among these declared drugs, there are 1,439 domestic Class 1 innovative drug registration applications, 1,383 clinical applications and 52 marketing applications
.
According to the statistics of drug types, there are 896 chemical drugs, 489 biological products (including 481 biological products for treatment), and 54 traditional Chinese medicines
.
It is understood that due to the influence of its own drug characteristics, the application of traditional Chinese medicine has always been in a relatively sluggish state, but the number of traditional Chinese medicine applications in 2021 has increased significantly
.
In this regard, the industry believes that this is inseparable from the help of policies
.
It is reported that in recent years, China has issued a series of policies and measures around the inheritance, innovation and development of traditional Chinese medicine
.
Among them, since the release and implementation of a series of documents such as the newly revised "Administrative Measures for Drug Registration" and "Requirements for Registration Classification and Application Materials of Traditional Chinese Medicines", the innovation vitality and potential of traditional Chinese medicines have been continuously released, and the enthusiasm for research and development of new traditional Chinese medicines has increased greatly and has been approved.
The number is also growing
.
The industry predicts that, according to the current industry trend, in 2022, the innovation vitality and potential of traditional Chinese medicine will continue to be released, and new approved drugs will continue to emerge
.
In fact, a number of new traditional Chinese medicines have been launched this year.
For example, on January 10, the State Food and Drug Administration announced that the State Food and Drug Administration recently approved the 1.
2-type innovative drug Epimedium with conditions through the priority review and approval process.
Vegetarian soft capsules were launched
.
This is the first innovative traditional Chinese medicine drug approved for marketing in my country since 2022
.
On January 4, Jianmin Group also issued an announcement saying that the 1.
1 class innovative traditional Chinese medicine Qirui Weishu Capsule was approved for marketing, which is used for mild to moderate chronic non-atrophic gastritis with erosive damp-heat stasis syndrome caused by epigastric pain, tongue Dark purple or ecchymosis petechiae, yellow and greasy tongue coating, stringy or slippery pulse
.
It is worth noting that, in addition to the continuous increase in the number of innovative traditional Chinese medicine drugs, there are actually data showing that the traditional Chinese medicine manufacturing market is also expanding.
From 2016 to 2020, China's traditional Chinese medicine manufacturing market has increased from 63.
7 billion yuan to 73.
7 billion yuan, with a compound annual growth rate of 3.
7%
.
According to this trend, the industry predicts that by 2025, the market size may reach 4,807.
17 billion yuan
.
In general, policy support plays an important role in promoting the development of the traditional Chinese medicine industry
.
Therefore, under the influence of a series of favorable policies and the improvement of review and approval efficiency, the research and development of new Chinese medicines is expected to enter a period of rapid development
.
In this context, more and more traditional Chinese medicine companies are expected to focus on the development of new drugs
.
In this regard, the industry suggested that future research can focus on the strength of strong, modern innovation the subject of major categories of traditional Chinese medicine layout; and benefit from consumption upgrade, extend the industrial chain focus, strong brand subject
.