Recently, the Drug Evaluation Center of the State Drug Administration issued a notice
on the public solicitation of opinions on the "Technical Guidelines for the Preparation and Research of Drugs for Clinical Trial of Chinese Medicines for New Drugs (Draft for Comment)".
The industry believes that this principle aims to accelerate the establishment and improvement of a technical evaluation system that meets the characteristics of traditional Chinese medicine, and to promote the research and development and innovation
of new Chinese medicine drugs in China.
In fact, in recent years, in order to inherit and develop the traditional Chinese medicine industry and accelerate the innovation and upgrading of traditional Chinese medicine pharmaceutical enterprises, a series of favorable policies for traditional Chinese medicine have been introduced
.
For example, the Opinions on Promoting the Innovative Development of Traditional Chinese Medicine Inheritance issued on October 26, 2019; On December 30, 2021, the State Medical Insurance Bureau and the State Administration of Traditional Chinese Medicine jointly issued the "Guiding Opinions on Medical Insurance Support for the Inheritance and Innovative Development of Traditional Chinese Medicine", which is vigorously encouraging the research and development
of new Chinese medicine drugs.
Among them, it is worth mentioning that in the context of the country's continuous deepening of the review and approval of traditional Chinese medicines and the reform of the regulatory system and mechanism, the time for the approval and listing of new Chinese medicines has also been greatly shortened
.
At present, under the influence of a series of policies, China's traditional Chinese medicine inheritance and innovation ability has been continuously enhanced, and the number of clinical trial applications for new Chinese medicine drugs and new drug marketing authorization applications has also begun to increase
year after year.
According to the data, in 2021, there will be 12 new Chinese medicine drugs approved for marketing in China, which has exceeded the sum of the past 4 years
.
In addition, in terms of clinical trials of new drugs, there will be 78 traditional Chinese medicines in 2021, an increase of 16.
4%
over 2020.
Since the beginning of this year, the research and development of new Chinese medicine drugs has continued to accelerate, and many Chinese medicine companies have ushered in new breakthroughs
in Class 1 new drugs.
For example, on September 15, the State Drug Administration issued a news that approved the listing registration application
of Wuhan Guanggu Renfu Biopharmaceutical Co.
, Ltd.
's Class 1.
2 Chinese medicine innovative drug Guangqiancao total flavonoids capsules.
The new drug mainly extracts the total flavonoids obtained from Guangqian Herb, which can be used for the treatment of ureteral stones in the treatment
of patients with damp heat accumulation syndrome in traditional Chinese medicine.
News on January 10, the State Drug Administration issued a conditional approval of the 1.
2
class of innovative drug epimedium soft capsules through the priority review and approval process.
The listing of this variety offers new treatment options
for hepatocellular carcinoma patients.
The holder of the drug marketing authorization is Beijing Yannuoji Pharmaceutical Technology Co.
, Ltd.
In addition to the above drugs, many new Chinese medicine drugs were approved to enter the clinical trial stage in the first half of the
year.
For example, the Qianqing Granules, a class 1 new drug of traditional Chinese medicine independently developed by Warner Pharmaceutical Co.
, Ltd.
, has completed Phase I clinical trials and has launched phase II clinical trials, and the research project on alternatives to rare and endangered animal medicinal materials in which the company participates has also made certain progress
.
Including dry and clear granules, according to the data statistics of the Drug Evaluation Center of the State Drug Administration, as of now, a total of 45 new Chinese medicine drug acceptance numbers have been undertaken
this year.
Among them, in the second half of 2022 (July 1 to September 21), a total of 12 new Chinese medicine drug acceptance numbers were handled, including 10 new drugs of class 1 and 2 new drugs of class 2; There are 6 new Chinese medicine drugs for IND applications
.
In general, with the significant enhancement of the innovation ability of traditional Chinese medicine, the application for clinical trials of new Chinese medicine drugs is also growing
.
In the future, with the continuous promotion of favorable policies, innovative Chinese medicine drugs are expected to be rapidly produced and usher in an outbreak
.
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