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On August 6, the Insight database showed that Jiahe Biologics CDK4/6 inhibitors started phase III clinical trials, combined with fulvestrant to treat hormone receptor (HR) positive human epidermal growth factor receptors after previous endocrine therapy.
2 (HER2) negative locally advanced or metastatic breast cancer patients
.
Lerociclib is a differentiated oral CDK4/6 inhibitor developed for the treatment of certain types of breast cancer and lung cancer patients in combination with other targeted drugs
.
On June 22, 2020, GenorBiopharma and G1 Therapeutics announced an exclusive license agreement for the development and commercialization of GB491 (Lerociclib) in the Asia-Pacific region (excluding Japan).
According to the data disclosed by the company, Lerociclib has an ORR of 31.
6% in the evaluable population, which has a significant therapeutic effect and shows better safety than other listed CDK4/6 inhibitors
.
Lower dose-limiting toxicity and low-frequency monitoring of adverse reactions in clinical use bring higher tolerance; the rate of neutropenia of grade 3 and above is lower than that of piperacillil and Ribociclib, and diarrhea The ratio is much lower than that of Abexicil, and the incidence of nausea and vomiting is not high, and they are all grade 1 or 2
In addition, in July this year, Lerociclib was also approved to carry out a phase III clinical trial of combined letrozole in the first-line treatment of HR-positive and HER2-negative advanced/metastatic breast cancer.
Currently, this clinical trial has not yet started
.
The sales of CDK4/6 inhibitors have grown strongly abroad, and they are now also a red sea in China
.
From the point of view of innovative drugs, in addition to the already approved piperacillil and abexiride, there are 16 projects under development; from the point of view of generic drugs, the first imitation of piperacillil has been approved, and there are still 7 models.
A few days ago, Hengrui Dalpiciclib has been the first to report for production, and it is the first domestically-made innovative drug to be produced; Jiahe and Simcere are following closely behind, in phase III clinical trials, and Novartis’s Reboxily is also in phase III clinical trials
.
Both Jiahe and Simcere's CDK4/6 were introduced from G1 Therapeutics.
From the Insight database (http://db.
