In recent years, supported by favorable policies, the enthusiasm for the research and development of new Chinese medicine drugs has been high, especially since 2021, the research and development results of innovative Chinese medicine drugs in China have entered the stage of gradual cashing, and a total of 12 new Chinese medicine drugs have been approved for listing, setting a new high
in the past five years.
In 2022, the enthusiasm for the research and development of new Chinese medicine drugs will continue to decrease, and new progress
will continue to be made.
For example, in the middle of September this year, the State Food and Drug Administration approved the application for
the listing and registration of a class 1 Chinese medicine innovative drug "Guangqiancao Total Flavone Capsules" developed by Wuhan Guanggu Renfu Biopharmaceutical Co.
, Ltd.
According to reports, the main ingredient of the drug is the total flavonoids extracted from the broad money grass, which can be used for the treatment of patients with damp heat in the traditional Chinese medicine of ureteral stones, and the listing will provide new treatment options
for patients with clinically related diseases.
The drug is also another breakthrough following the approval of the listing of a class 1 Chinese medicine innovative drug "Qirui Gastric Capsules" independently developed by Jianmin Pharmaceutical Group in December 2021
.
In addition, since the beginning of this year, there have been a number of blockbuster Chinese medicine innovative drugs in the clinical stage and new progress
.
For example, Kangchen Pharmaceutical recently announced that the company's phase III clinical trial of the company's innovative Chinese medicine golden herb tablets for the treatment of chronic pelvic pain in pelvic inflammatory diseases has obtained ethical review approval, and the current research of the project is progressing smoothly, and it is expected to complete the first case of subject enrollment
in the near future.
It is reported that Jincao tablets (total cyclic ether terpene glycosides tablets) is the first batch of innovative drugs of traditional Chinese medicine 1.
2 with the indication of "chronic pelvic pain sequelae of pelvic inflammatory diseases", which is an effective part preparation extracted from a single traditional Chinese medicine whole grass, the main ingredient is "total cyclic ether terpene glycosides", its material basis and mechanism of action are more clear, and it is accurately positioned in "chronic pelvic pain sequelae of pelvic inflammatory diseases", and the clinical application scenario is clear
.
At present, the sequelae of pelvic inflammatory disease chronic pelvic pain in China have not been approved for this indication
.
On September 22, Enwei Pharmaceutical issued an announcement that recently, Enwei Pharmaceutical, a wholly-owned subsidiary, received the "Notice of Approval of Drug Clinical Trials" issued by the State Food and Drug Administration, and approved the clinical trial
of the 1 class of innovative Chinese medicine Qiankunin tablets developed and researched by Enwei Pharmaceutical.
In May, Jiangshi Granules, an innovative drug in Chinese medicine of the China Pharmaceutical Research Institute, was approved by the State Food and Drug Administration to carry out clinical trials
for irritable bowel syndrome with weak spleen and stomach.
It is reported that Jiangshi granules is another new Chinese medicine drug provided by Beijing Qihuang Technology Co.
, Ltd.
(hereinafter referred to as "Qihuang CRO") to complete the IND application and obtain the "Drug Clinical Trial Approval Notice"
.
Earlier, in February, Yunnan Baiyao announced that the company's declaration of a new class of traditional Chinese medicine drug "Quansanqi Tablets" was approved by the State Food and Drug Administration for clinical trial approval of drugs, agreeing to carry out clinical trials
for chest tightness and heartache caused by cardiac artery stasis.
It is reported that the project is the first approved new Chinese medicine class 1 drug in Yunnan Baiyao after the reform of the registration classification of traditional Chinese medicine, and it is also the second new drug of traditional Chinese medicine certificate that the company has independent intellectual property rights and has been approved after the attached gu ointment
.
With the advancement of the research and development of more innovative Chinese medicine drugs, if the follow-up progress is smooth, it will further promote the innovation and development of the traditional Chinese medicine industry and meet the clinical treatment needs
of the majority of patients.
Southwest Securities once said in the research report that under the background of the standardization of review and approval, the number of listed Chinese medicine innovative drugs has grown steadily, and from the perspective of the number of declarations, this trend will continue to be maintained in the future, and the long-term growth of traditional Chinese medicine innovative drugs can be expected
.
