The innovation of domestic chemical drugs is still continuing, but it is entering the slow lane

【Pharmaceutical Network Market Analysis】Chemical preparation industry refers to the manufacture of chemical preparations directly used for human disease prevention and diagnosis, which is a very important part of
China's biomedical industry.
According to incomplete statistics, in October 2022, CDE undertook a total of 973 new drug registration applications by acceptance number (except for review, the same below), of which 723 were accepted for chemical drugs, 97 for traditional Chinese medicines, and 153 for biological products
.
Specifically, in October, CDE undertook 723 new chemical drug registration applications (in terms of acceptance number), including 106 new drug application acceptance numbers, 45 import acceptance numbers, 217 generic application acceptance numbers, 330 supplementary applications, and 25 import
re-registrations.
From the above number of registrations, it is obvious that domestic pharmaceutical companies are still very enthusiastic
about the research and development of chemical drugs.
In fact, China's chemical pharmaceutical industry has long been dominated by generic drugs, but with the implementation of the "consistency evaluation" of generic drug quality and efficacy, the research and development and quality of generic drugs have been continuously improved, chemical innovative drugs have also begun to obtain more extensive research, and the direction of innovative research and development of chemical drugs has gradually changed
to the "combination of innovation and imitation" model.
At present, many pharmaceutical companies have begun to make new breakthroughs
in Class 1 new drugs.
For example, recently, the State Medical Products Administration approved the marketing
of Torludiven Lafaxine hydrochloride sustained-release tablets (trade name: Ruoxinlin), a Class 1 innovative drug declared by Shandong Luye Pharmaceutical Co.
, Ltd.
The drug is an innovative drug independently developed by China with independent intellectual property rights, which is suitable for the treatment
of depression.
The antidepressant effect of torludivenlafaxine hydrochloride may be related to
the enhancement of 5-HT, NE effects of the central nervous system by inhibiting the reuptake of serotonin (5-HT), norepinephrine (NE).
The launch of the drug provides more treatment options
for patients with depression.
In addition to Ruoxinlin, according to the data, in October, CDE accepted a total of 85 domestic class 1 new drugs (calculated by acceptance number), including 83 IND applications and 2 NDA applications, involving 40 varieties (according to the dimension of drugs + enterprises), all of which have entered the corresponding sequence of queues for review
.
Industry analysis believes that with the further improvement of the technical level of China's chemical pharmaceutical industry and the continuous emergence of innovative products, the market scale of high-tech chemicals is expected to further expand, thereby driving the rapid development of
China's chemical preparation industry.
However, it should be noted that at present, from the perspective of the decrease in new drug applications and approvals, chemical drug innovation is slowing down
.
The data shows that in September, CDE accepted a total of 92 domestic Class 1 new drugs (by acceptance number), including 90 IND applications and 2 NDA applications, involving 51 varieties (according to the dimension of drugs + enterprises).

In addition, from January 2022 to June 30, 2022, the NMPA only approved 5 Class 1 chemical drugs (by variety), a decrease of 72.
22%
compared with 18 new drugs in the first half of 2021.
Under the background that chemical drug innovation is still continuing, but it is entering the slow lane, analysts have proposed that how to carry out high-level innovation of chemical drug innovation, improve source innovation capabilities, and solve unmet clinical needs will become an urgent problem
for the future development of pharmaceutical companies.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.