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On April 21, the CDE official website showed that Hengrui’s CDK4/6 inhibitor SHR6390 tablet listing application was planned to be included in the priority review, and the indication was combined with Fulvestrant for hormone receptor (HR) positive, and human epidermal growth factor was affected.
SHR6390 is a class 1 new drug developed by Jiangsu Hengrui Pharmaceutical Co.
On December 24 last year, Hengrui announced that SHR6390 combined with fulvestrant in the treatment of HR-positive, HER2-negative, locally advanced or advanced breast cancer after endocrine therapy has reached the primary research endpoint.
This phase III clinical trial (SHR6390-III-301) is an evaluation of SHR6390 combined with fulvestrant versus placebo combined with fulvestrant in the treatment of HR-positive, HER2-negative locally advanced or late metastatic disease after previous endocrine therapy.
The primary endpoint of the trial is progression-free survival (PFS) assessed according to the RECISTv1.
A total of 361 subjects were enrolled in the trial.
At present, four CDK4/6 inhibitors have been approved globally, namely Pfizer’s palbociclib (pibaciclib), Novartis’s Ribociclib, Eli Lilly’s Abemaciclib and G1 Therapeutics’ Trilaciclib ( Domestic authorized to Simcere Pharmaceuticals).
Image source: Insight database (https://db.
Image source: Insight database (https://db.
The competitive landscape of domestic CDK4/6 inhibitors in research new drugs:
Image source: Insight database (https://db.
Image source: Insight database (https://db.
dxy.
cn/v5/home)