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【Pharmaceutical Network Industry News】Recently, the State Food and Drug Administration approved the listing registration application
of Wuhan Guanggu Renfu's class 1.
2 class of traditional Chinese medicine innovative drug Guangqiancao total flavone capsules.
It is reported that the drug adopts the purification technology of large-hole adsorption resin, and the total flavonoids of Guangqian grass are isolated in the single-flavor Chinese herbal medicine of Guangqian herb, and the effective part is used to form a formula for research and development into an innovative preparation
of modern Chinese medicine.
Its characteristics include: clear effective substance, good stability, high quality controllability, good safety; It is conducive to anti-inflammatory, dissolved stone discharge, painless stone removal, and prevention of stone formation
.
The drug has been carried out randomized, double-blind, placebo parallel controlled, multicenter clinical trials, the results of the study show that there is a statistical difference between the placebo control group, can be used for ureteral stones in the treatment of patients with damp heat syndrome in traditional Chinese medicine
.
It is worth mentioning that the drug is also another breakthrough following the approval of the listing of a class 1 Chinese medicine innovative drug "Qirui Gastric Capsule" independently developed by Jianmin Pharmaceutical in December 2021
.
Its post-marketing will bring new treatment options
to relevant patients.
According to the data, Wuhan Optics Valley Renfu was established on August 5, 2010, and its business scope includes drug research and production; R&D, wholesale and retail sales of chemical products (except chemical dangerous goods) and technology development, technology transfer and technical services; Investment in the pharmaceutical industry, management of pharmaceutical projects, etc
.
Chinese medicine is the cornerstone of the development of Chinese medicine, and innovative development has become the main theme
.
In order to support the innovation of traditional Chinese medicine, in recent years, a series of policies, including the Notice on Several Policies on Accelerating the Development of the Development of the Characteristics of Traditional Chinese Medicine, the Requirements for Registration Classification and Declaration Materials of Traditional Chinese Medicine, the Technical Guidelines for Pharmaceutical Research of Compound Preparations of Traditional Chinese Medicine Managed According to the Catalogue of Ancient Classic Prescriptions (Trial), and the Guiding Opinions on Medical Insurance to Support the Inheritance and Innovative Development of Traditional Chinese Medicine, have attracted a large number of pharmaceutical companies to lay out innovative Chinese medicine drugs, and the innovative achievements have continued to usher in a harvest period
。
According to statistics, in 2021, the innovative drugs of traditional Chinese medicine ushered in an outbreak, and there were Huzhen Qingfeng capsules, anti-depression and annoyance capsules, silver warp Qingyang heat tablets, Xuanqi Jian bone tablets, Qi Li Yi kidney capsules, Kunxinning granules, clear lung detoxification granules, wet septic granules, and Xuan lung septic granules; In September, 12 new Chinese medicine drugs such as Yiren Nourishing Heart Tranquility Tablets and Yiqi Tongzhi Pills approved in September have been approved, and the number has exceeded the sum of the past 4 years, and the indications cover many diseases such as respiratory system, digestive system, endocrine diseases, and neurological diseases, and randomized, double-blind, placebo parallel control group and multi-center clinical trial research
have been carried out in the development process.
Entering 2022, in addition to Wuhan Guanggu Renfu, there are many innovative Chinese medicine drugs approved for clinical trials, such as February 28, Yunnan Baiyao declared a new Chinese medicine class 1 new drug "Quan Sanqi Tablets" passed the news of approval by the State Food and Drug Administration, the drug will be used for chest tightness and heartache caused by heart artery stasis
.
The "14th Five-Year Plan for the Development of Traditional Chinese Medicine" proposes to build a high-level traditional Chinese medicine inheritance protection and scientific and technological innovation system, and reform and improve the registration management
of traditional Chinese medicine.
The industry believes that the document will help further stimulate the vitality of new drug research and development of traditional Chinese medicine, and it is expected that innovative drugs in traditional Chinese medicine will continue to usher in an outbreak
.
Huaan Securities predicts that the approval of new Chinese medicine drugs will accelerate in the future, and it is likely to exceed 20 per year
.
Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.