Recently, Tasly issued an announcement that its wholly-owned subsidiary, Jiangsu Tasly Diyi Pharmaceutical, received the "Drug Registration Certificate"
of bortezomib for injection issued by the State Food and Drug Administration.
According to the data, bortezomib for injection is another anti-tumor injection product
that Tasly obtained a drug registration certificate after the approval of temozolomide for injection.
It is worth mentioning that on the previous day, another chemical drug of Diyi Pharmaceutical, lisinopril hydrochlorothiazide tablets, has also become the first product
in China to pass the consistency evaluation.
This product is used to treat hypertension and is a Class B variety
of the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue (2021).
At present, there are 2 companies in the domestic market with the approval number of lisinopril hydrochlorothiazide tablets
.
It is understood that in recent years, for chemical drugs, Tasly has formulated a research and development strategy that combines creation and imitation, focusing on anti-tumor, cardiovascular, digestive metabolism and spiritual fields, laying out a number of first-class innovative drugs and generic drugs, and accelerating the introduction of the world's leading level of clinical late-stage innovative drugs
.
It can be seen from the 2022 semi-annual report that Tasly Chemical Innovative Drug Products have made phased progress: antidepressant JS1-1-01 submitted the application for supplementary application for increased specifications, and has obtained the ethical approval of Phase Ib clinical trials; Class 1 innovative PARP inhibitors have entered Phase II clinical trials
.
Rivaroxaban tablets, nicoldiol for injection, propacaterol hydrochloride oral solution, afatinib maleate tablets and other generic drugs are in the declaration and production stage
.
At present, in addition to Tasly's successive breakthroughs in chemical drugs, Yiling Pharmaceutical also said in response to investors' questions on the interactive platform on August 31 that the new chemical drug anilineprofen has completed the clinical phase III study and is preparing for
the application for new drugs.
It is worth mentioning that in terms of chemical drugs, Yiling Pharmaceutical has basically realized the first step of strategic planning of "completing the production and quality system of European and American GMP certification and the commercial production of products", and has simultaneously carried out research and development of generic drugs and patented innovative drugs and completed the two- and three-step strategic planning
of European and American countries and domestic registration.
On July 29, Kanghong Pharmaceutical also issued an announcement that its subsidiary Honghe Bio has been notified by the US Food and Drug Administration (FDA) to carry out clinical trials
of new drugs for its KH617.
According to the data, KH617 is a high-purity API produced by biosynthesis technology, which is a class 1 innovative chemical drug intended for the treatment of patients with advanced solid tumors (including adult diffuse glioma
).
In addition to the above products, statistics show that in August 2022, CDE undertook a total of 1290 new drug registration applications with acceptance numbers (except for review), of which 922 were accepted
for chemical drugs.
In addition, in June, a total of 152 chemical drug class 1 new drug acceptance numbers were undertaken by CDE (including 39 supplementary applications), 82 of which were made in China and 31 were imported
.
Analysts believe that it is obvious from the number of registrations that the enthusiasm of domestic pharmaceutical companies for the research and development of new chemical drugs is continuing to rise
.
In this regard, the industry believes that this is mainly due to the huge investment and development value of China's chemical drug market, and the current stage of rapid differentiation, structural upgrading and elimination of backward production capacity in China's chemical preparation industry
.
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 cashed in
.
