Recently, Tasly said that the company's two chemical drugs have been approved one after another, and the research and development pipeline has gradually been cashed in
.
The two products are bortezomib for injection and lisinopril hydrochlorothiazide tablets
.
In addition, Tasly also said in the interim report that in the future, it will gradually realize an innovative product portfolio
through global research and development declaration and synchronous listing.
Bortezomib for Tasly injection obtained a drug registration certificate
.
On September 6, Tasly announced that jiangsu Diyi, a wholly-owned subsidiary of the company, recently received the "Drug Registration Certificate"
approved and issued by the State Drug Administration on bortezomib for injection.
Bortezomib for Tasly injection obtained a drug registration certificate
.
According to the data, bortezomib is a bipeptide-based borate analogue, which is a synthetic new proteasome competition inhibitor for clinical use, as one of the anti-tumor drugs, for the treatment
of multiple myeloma and sleeve cell lymphoma.
Bortezomib (3.
5 mg/bottle) for injection is owned by Janssen-Cilag International N.
V.
, which was approved for marketing by the US FDA in May 2003, authorized for listing in the European Union in April 2004, and approved by NMPA to enter the Chinese market
in February 2005.
Jiangsu Diyi bortezomib for injection completed production verification in May 2020, declared the CDE technical review in February 2021, and recently obtained the "Drug Registration Certificate" approved and issued by the State Food and Drug Administration
.
Up to now, Jiangsu Diyi has invested 16.
6915 million yuan
in the cumulative research and development of the project.
Tasly lisinopril hydrochlorothiazide tablets were approved
.
On the same day, Tasly issued an announcement that its wholly-owned subsidiary, Jiangsu Diyi, received the "Notice of Approval of Drug Supplement Application" issued by the State Food and Drug Administration on lisinopril hydrochlorothiazide tablets, approving the drug to pass the consistency evaluation
of generic drug quality and efficacy.
Tasly lisinopril hydrochlorothiazide tablets were approved
.
According to the data, lisinopril hydrochlorothiazide tablets are used to treat high blood pressure, which is a class B variety
of the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue (2021).
The drug was accepted by cde on August 2, 2021, and was recently approved by the State Food and Drug Administration to issue the "Notice of Approval of Drug Supplement Application"
.
Up to now, Jiangsu Diyi has invested 11.
8322 million yuan
in research and development for the consistency evaluation of the drug.
At present, there are 2 companies in the domestic market with the approval number of lisinopril hydrochlorothiazide tablets, and Tasly is the first company
to pass the consistency evaluation of the drug.
It is understood that 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 variety of first-class innovative drugs and generic drugs, and accelerating the introduction of high-level clinical innovative drugs
.
At present, the company has developed 46 products for chemical drugs and continuously optimized pipeline products
.
Since the beginning of this year, the research and development progress of Tasly Chemical's innovative drugs has also accelerated significantly, the PARP inhibitor Phase II trial has recently completed the enrollment of the first case of subjects, and the antidepressant JS1-1-01 has obtained the ethical approval of the Phase Ib clinical trial, etc.
, showing that the company's chemical drug research and development strategy combined with imitation has achieved results, and the pipeline product landing is gradually being cashed
in.
