All in one article to cover the opportunity of Chinese patent medicine project!

The new "Administrative Measures for Drug Registration", which was officially implemented on July 1, 2020, classifies the registration of traditional Chinese medicines according to innovative traditional Chinese medicines, new improved traditional Chinese medicines, traditional Chinese medicine compound preparations with ancient classic prescriptions, and drugs with the same name and the same prescripti.

This article tracks the clinical application and production of proprietary Chinese medicines from 2020 to the present (as of July 20, 2022), and analyzes them by category to explore opportunities for Chinese medicine research and developme.

It can be seen from the application and registration data that the research and development of traditional Chinese medicine is gradually picking .

Innovative traditional Chinese medicine drugs, that is, Class 1 traditional Chinese medicines, refer to those whose prescriptions are not included in the national drug standards, drug registration standards and the "Catalogue of Ancient Classic Famous Prescriptions" issued by the national Chinese medicine authority, have clinical value, and are not listed overse.

The data analysis of Xianda Pharmacy found that innovative traditional Chinese medicine drugs have the largest number of application categories, whether they are reported for clinical or producti.

The five products of innovative traditional Chinese medicine drugs reported for production in 2020, namely Liwei Capsules, Qihuang Capsules, Jingule Tablets, Huzhen Qingfeng Capsules and Yinqiao Qingre Tablets, have all been approved for marketi.

Among them, category 1 (compound preparations of traditional Chinese medicine) is the sub-category with the largest number of clinical and production declaratio.

After 2020, the innovative traditional Chinese medicine drugs that have been approved for production are basically oral solid preparations, and no traditional Chinese medicine injections have been approved for marketi.

Of the 16 TCM preparations reported for production after 2020, a total of 8 have registration data on the drug clinical trial registration and information publicity platform, all of which are Class 1 new TCM dru.

[Project Inspiration]Innovative Chinese medicines (Class 1 Chinese medicines) are currently the products with the highest approval success rate, but Chinese medicine injections are basically no longer the focus of companies in their project establishme.

The research and development cycle of innovative traditional Chinese medicine drugs is generally more than 15 yea.

New improved traditional Chinese medicine drugs, namely Class 2 traditional Chinese medicines, refer to preparations that change the route of administration and dosage form of traditional Chinese medicines already on the market, and have clinical application advantages and characteristics, or increase functions and indications; they are further subdivided into 1, 2, 3 class, 4 cla.

In 2022 (as of July 20, 2022), the number of clinical applications for improved new Chinese medicine drugs has been the same as in 2021, but no products have been reported for producti.

【Project initiation inspiration】According to the current centralized procurement rules for proprietary Chinese medicines, there is a high probability that the dosage forms of the same route of administration should be combined for centralized procureme.

In addition, due to the low probability of approval of traditional Chinese medicine injections, a better direction for improving the administration route of traditional Chinese medicines is: traditional Chinese medicine injections are changed to oral medicines, or traditional Chinese medicine injections are changed to external use, or oral traditional Chinese medicines are changed to external u.

There are three types of traditional Chinese medicin.

Traditional Chinese medicine compound preparations with ancient classic prescriptions can be directly declared without starting clinical tria.

In 2022, there will be 2 acceptance numbers for production, both of which are Category 1 (traditional Chinese medicine compound preparations managed according to the catalogue of ancient classic prescriptions), respectively Hefei China Resources Taohong Siwu Granules from Shenlu Pharmaceutical and Linggui Zhugan Granules from Jiangsu Kangyuan Pharmaceutic.

Taohong Siwu Decoction and Linggui Shugan Decoction are both in the "Catalogue of Ancient Classic Famous Prescriptions (First Batch)" formulated by the State Administration of Traditional Chinese Medicine and the State Drug Administration in 2018, and will be included in the "Ancient Classics" in 2020 Key information table of famous prescriptions (7 prescriptions.

[Project Inspiration]In view of the fact that there are only 7 products in the "Key Information Table of Ancient Classic Famous Prescriptions (7 Prescriptions)" currently published, they are: Lingguishugan Decoction, Wenjing Decoction, Yiguanjian, Taohong Siwu Decoction, Sheng Trapped soup, loquat Qingfei drink and Erdong so.

It is expected that the first batch of application hot spots for ancient classic prescriptions will also focus on these 7 products, and there is a high probability that companies will apply from 2022, and the application forms are mainly granul.

However, the research threshold for such products is not high, and whoever masters the core medicinal materials in the future is expected to win the price war for such produc.

The same name and the same prescription, that is, 4 types of traditional Chinese medicine, refers to the common name, prescription, dosage form, functions and indications, usage and daily dosage of decoction pieces are the same as those of the listed traditional Chinese medicine, and the safety, effectiveness, and quality controllability are not lower than the sa.

Preparations of traditional Chinese medicines on the mark.

In 2022 (as of July 20, 2022), one product of the same-name and same-prescription drug will finally be submitted for clinical application, which is the national medicine Tongji Heya Rixianbeier Tabl.

【Project Inspiration】 There are not many companies with the same name and the same name, and the key factor is that the guiding principles have not been issu.

It is not yet clear whether the generic drugs of traditional Chinese medicines need to do the same bioequivalence studies as the generic drugs of chemical dru.

If a bioequivalence study is to be done, the research and development of the same name and the same prescription will be more difficu.

Among them, traditional Chinese medicine injections are more like multi-component injections of chemical drugs, and it is difficult to exempt from bioequivalence studies with high probabili.

It is expected that a bioequivalence study may be exempted from a single-component oral liquid formulati.