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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 research endpoint of the trial is progression-free survival (PFS) assessed according to the RECISTv1.
A total of 361 subjects were enrolled in the trial, randomly enrolled according to 2:1, and received SHR6390 or placebo combined with fulvestrant, every 28 days as a treatment cycle, of which SHR6390 or placebo was taken continuously in the first 3 weeks, and then One week of rest (without medication), treatment until disease progression, intolerable toxicity, or other conditions that require termination of treatment.
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).
At present, Pfizer Pipercill (trade name: Aiboxin) and Eli Lilly’s Abbeceil (trade name: Weizhe) have been approved in China; among them, the first domestic copy of piperacill has been taken first by Qilu.