The chemical preparation industry refers to the manufacture of chemical preparations directly used for the prevention and treatment and diagnosis of human diseases, and it has always occupied an important position
as a very large sub-industry of the pharmaceutical industry.
According to incomplete statistics (data statistics as of September 29, 2022, the same below), in September 2022, CDE undertook a total of 1189 new drug registration applications in terms of acceptance number (except for review, the same below), of which 865 were accepted for chemical drugs, 149 were accepted for traditional Chinese medicines, 174 were accepted for biological products, and 1 in vitro diagnostic reagent
.
In August, CDE undertook a total of 1290 new drug registration applications in terms of acceptance number (except for review, the same below), of which 922 chemical drugs were accepted, 166 were accepted by traditional Chinese medicines, and 202 were accepted by biological products In July, CDE accepted chemical drugs and domestic class 1 new drugs also had a total of 77 (according to the acceptance number), of which 2 were NDA applications and 77 were IND applications, involving 37 varieties (according to the drug + enterprise dimension).
In June, a total of 152 new drug acceptance numbers of chemical drugs and class 1 drugs were undertaken by CDE (including 39 supplementary applications), of which 82 were domestically produced and 31 were imported
.
From the above number of registrations, it can be clearly seen that the enthusiasm of domestic pharmaceutical companies for the research and development of chemical drugs is still very high
.
It is understood that at present, China has a relatively complete chemical preparation industry system, it is worth mentioning that in the number of chemical drug registrations continue to grow, and the chemical preparation industry market continues to grow at the same time, chemical drug 1 class new drug research and development is also constantly making new breakthroughs
.
It is understood that in September, CDE accepted a total of 92 domestic class 1 new drugs (according to the acceptance number), of which 90 IND applications and 2 NDA applications, involving 51 varieties (according to the drug + enterprise dimension statistics), most of the current acceptance numbers have entered the corresponding review sequence queued for review
.
According to the CDE announcement, in September, there are 4 new chemical drugs approved for marketing, namely Idarabon sublingual tablets, rivaroxaban tablets, dapagliflozin tablets, olaparil tablets, of which 3 are 2 types of improved new drugs and 1 imported original research
.
From the overall point of view, domestic pharmaceutical companies have been very enthusiastic
about the research and development of new drugs such as chemical drugs 1.
The industry believes that this is mainly due to the huge investment and development value of China's chemical drug market, and data show that the sales of chemical drugs in public hospitals in key cities in 2019 are close to 180 billion yuan
.
In the future, as pharmaceutical companies continue to invest in the innovative research and development of chemical drugs, it is expected that more and more enterprise research and development pipelines will gradually be realized, and the domestic chemical drug market will continue to expand
.
However, it is worth noting that at present, China's chemical preparation industry has entered the stage
of rapid differentiation, structural upgrading, and elimination of backward production capacity.
Therefore, enterprises with independent innovation capabilities in medicine and intellectual property protection will be in an advantageous position
in the future competition market for chemical preparations.
With the further improvement of the technical level of China's chemical and pharmaceutical industry, the market size of high-tech chemical drugs is expected to be further expanded, thus driving the rapid development
of China's chemical preparation industry.
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