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In recent years, with the release and implementation of a series of documents such as the "Administrative Measures for Drug Registration" and "Requirements for Registration Classification and Application Materials of Traditional Chinese Medicine", innovative traditional Chinese medicine drugs have begun to be rapidly produced.
For example, in 2021, the number of approved innovative traditional Chinese medicine drugs will reach 11, the highest since 2013
.
Entering 2022, the innovative vitality and potential of traditional Chinese medicines are still being released, the enthusiasm for the research and development of new traditional Chinese medicines has greatly increased, and the approved ones continue to emerge
.
For example, on January 10, the State Food and Drug Administration announced that recently, the State Food and Drug Administration approved the 1.
2 category innovative drug icariin soft capsules with conditions through the priority review and approval process
.
The drug will be used to treat liver cancer
.
This is also the first innovative traditional Chinese medicine drug approved for marketing in China since 2022
.
It is understood that icariin (acoladine) soft capsule is an original new traditional Chinese medicine independently developed by Beijing Shennuoji Pharmaceutical Technology Co.
, Ltd.
It is a small molecule immunomodulator
.
Clinical trial data show that: icariin (acoladine) soft capsules are suitable for unresectable hepatocellular carcinoma who are not suitable or patients refuse to receive standard treatment and have not received systemic treatment before.
The markers meet at least two of the following detection indicators: AFP≥400 ng/mL; TNF-α
.
In addition, on January 4, Jianmin Group also issued an announcement stating that the 1.
1 class innovative traditional Chinese medicine Qirui Weishu Capsule was approved for marketing, for mild to moderate chronic non-atrophic gastritis with erosive damp-heat stasis syndrome caused by epigastric pain , Dark purple tongue or petechiae, yellow and greasy tongue coating, stringy or slippery pulse
.
The data show that Qirui Weishu Capsule is an innovative traditional Chinese medicine drug developed on the basis of preparations in medical institutions.
It has a good clinical application foundation, and its safety and effectiveness have been fully verified
.
At the same time, the series of pharmacological and toxicological studies and clinical trial data of Qirui Weishu Capsules show that the drug has a significant effect in the treatment of chronic non-atrophic gastritis with erosion and damp-heat stasis syndrome, especially in improving epigastric pain and TCM syndromes.
In other aspects, the curative effect is significantly better than that of the positive control drug, and the safety is good, and it has good clinical application value
.
It is expected in the industry that the launch of this variety will provide a new treatment option for patients with chronic gastritis
.
In fact, for a long time, the traditional Chinese medicine industry has been facing the difficulty of innovation, and research and development generally faces the problems of unclear mechanism of action and unclear active ingredients
.
However, from the above point of view, the innovative development of the traditional Chinese medicine industry has begun to accelerate in recent years, and the number of approved innovative traditional Chinese medicines has continued to increase
.
The industry believes that this is mainly due to the continuous introduction of favorable policies by the state and local governments in recent years to support the innovative development of the traditional Chinese medicine industry
.
On the whole, the development of the traditional Chinese medicine industry has obviously become a long-term plan of the country and even all regions
.
Against this background, the industry expects that in the face of the pressure of centralized procurement and in order to further expand their performance, traditional Chinese medicine companies are expected to start to strengthen the research and development of traditional Chinese medicine products
.
Affected by this, more and more new Chinese medicines will emerge in the industry one after another
.
For example, in 2021, the number of approved innovative traditional Chinese medicine drugs will reach 11, the highest since 2013
.
Entering 2022, the innovative vitality and potential of traditional Chinese medicines are still being released, the enthusiasm for the research and development of new traditional Chinese medicines has greatly increased, and the approved ones continue to emerge
.
For example, on January 10, the State Food and Drug Administration announced that recently, the State Food and Drug Administration approved the 1.
2 category innovative drug icariin soft capsules with conditions through the priority review and approval process
.
The drug will be used to treat liver cancer
.
This is also the first innovative traditional Chinese medicine drug approved for marketing in China since 2022
.
It is understood that icariin (acoladine) soft capsule is an original new traditional Chinese medicine independently developed by Beijing Shennuoji Pharmaceutical Technology Co.
, Ltd.
It is a small molecule immunomodulator
.
Clinical trial data show that: icariin (acoladine) soft capsules are suitable for unresectable hepatocellular carcinoma who are not suitable or patients refuse to receive standard treatment and have not received systemic treatment before.
The markers meet at least two of the following detection indicators: AFP≥400 ng/mL; TNF-α
.
In addition, on January 4, Jianmin Group also issued an announcement stating that the 1.
1 class innovative traditional Chinese medicine Qirui Weishu Capsule was approved for marketing, for mild to moderate chronic non-atrophic gastritis with erosive damp-heat stasis syndrome caused by epigastric pain , Dark purple tongue or petechiae, yellow and greasy tongue coating, stringy or slippery pulse
.
The data show that Qirui Weishu Capsule is an innovative traditional Chinese medicine drug developed on the basis of preparations in medical institutions.
It has a good clinical application foundation, and its safety and effectiveness have been fully verified
.
At the same time, the series of pharmacological and toxicological studies and clinical trial data of Qirui Weishu Capsules show that the drug has a significant effect in the treatment of chronic non-atrophic gastritis with erosion and damp-heat stasis syndrome, especially in improving epigastric pain and TCM syndromes.
In other aspects, the curative effect is significantly better than that of the positive control drug, and the safety is good, and it has good clinical application value
.
It is expected in the industry that the launch of this variety will provide a new treatment option for patients with chronic gastritis
.
In fact, for a long time, the traditional Chinese medicine industry has been facing the difficulty of innovation, and research and development generally faces the problems of unclear mechanism of action and unclear active ingredients
.
However, from the above point of view, the innovative development of the traditional Chinese medicine industry has begun to accelerate in recent years, and the number of approved innovative traditional Chinese medicines has continued to increase
.
The industry believes that this is mainly due to the continuous introduction of favorable policies by the state and local governments in recent years to support the innovative development of the traditional Chinese medicine industry
.
On the whole, the development of the traditional Chinese medicine industry has obviously become a long-term plan of the country and even all regions
.
Against this background, the industry expects that in the face of the pressure of centralized procurement and in order to further expand their performance, traditional Chinese medicine companies are expected to start to strengthen the research and development of traditional Chinese medicine products
.
Affected by this, more and more new Chinese medicines will emerge in the industry one after another
.