Clinical trials are a very important part of new drug research and development, and it is also an indispensable link
for each new drug before it is approved for production and put on the market.
At present, with the continuous rise of enthusiasm for new drug research and development at home and abroad, the continuous increase of investment in R&D of pharmaceutical companies, and the acceleration of new drug review and approval, a large number of new drugs at home and abroad have been approved to enter the clinical trial stage
in China.
Pfizer: ARV-471 (PF-07850327) tablets
Recently, according to the website of the Center for Drug Evaluation (CDE) of the China National Food and Drug Administration, Pfizer's ARV-471 (PF-07850327) tablet clinical trial application passed the "implied permission"
.
According to public information, ARV-471 (PF-07850327) tablet is a protein-degrading targeted chimera
that targets the degradation of estrogen receptors (ER).
The drug is currently in a dose-extended Phase 2 clinical trial
of monotherapy for ER+/HER2-breast cancer.
In China, the clinical indication for the drug is ER+/HER2-breast cancer
.
AstraZeneca: AZD5718 tablets
The clinical trial application of AstraZeneca AZD5718 tablets has recently passed the "implied permission", and the drug has been approved for clinical trial in China, and the proposed development indication is chronic kidney disease
.
AZD5718 is known to be a selective, reversible 5-lipoxygenase-activating protein (FLAP) inhibitor that can inhibit leukotriene production
.
Overseas, the drug has previously shown positive efficacy
in phase 2 clinical trials in patients with proteinuria chronic kidney disease with or without type 2 diabetes.
Novartis: JDQ443 pieces, TNO155 pieces
According to the CDE website, the clinical trial applications of Novartis JDQ443 tablets and TNO155 tablets have passed the "implied permission" for advanced solid tumors
with indications for KRAS G12C mutations.
It is understood that JDQ443 is an oral selective KRAS G12C covalent inhibitor, which can irreversibly lock KRAS G12C in an inactivated state and show good anti-cancer activity
in preclinical research.
TNO155 is a SHP2 inhibitor
under development by Novartis.
Overseas, JDQ443 and TNO155 are conducting a number of phase 3 clinical studies
of single or combination drugs.
Henlius: HLX60
Recently, the clinical trial application of Henlius HLX60 passed the "implied permission"
.
HLX60 is an innovative anti-GARP monoclonal antibody
developed by it.
By specifically binding GARP, it can block the release of GARP-mediated TGF-β1, reverse the immunosuppressive effect in the tumor microenvironment, and improve the anti-tumor immune response
.
In China, the clinical indications approved for the drug are solid tumors and lymphomas
.
Previously, HLX60 has been approved overseas and phase 1 clinical trials
have been initiated.
In addition to the above drugs, BMScendakimab injection, I-Mab Punalimab injection, and Jinlan gene GC101 adeno-associated virus injection have also been approved for clinical trials
recently.
The industry believes that innovation is the main theme of the development of the pharmaceutical industry, and in the context of accelerating the review and review of new drugs in China, more new drugs will enter the market to further solve the problem of clinical treatment selection for
some patients.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.
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