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    Home > Active Ingredient News > Endocrine System > Hengrui CDK4/6 inhibitor is reported to be listed and plans to be included in priority...

    Hengrui CDK4/6 inhibitor is reported to be listed and plans to be included in priority...

    • Last Update: 2021-05-10
    • Source: Internet
    • Author: User
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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.
    Treatment of recurrent or metastatic breast cancer that has progressed after endocrine therapy with negative body 2 (HER2).

    SHR6390 is a class 1 new drug developed by Jiangsu Hengrui Pharmaceutical Co.
    , Ltd.
    It is an oral, highly effective and selective small molecule CDK4/6 inhibitor.

    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.
    A multi-center, randomized, controlled, double-blind phase III clinical study of breast cancer (NCT03927456), with Professor Xu Binghe from the Cancer Hospital of the Chinese Academy of Medical Sciences as the main investigator, and the participation of 42 centers across the country.

    The primary endpoint of the trial is progression-free survival (PFS) assessed according to the RECISTv1.
    1 standard, and the secondary endpoints include progression-free survival (PFS), overall survival (OS), and overall response rate assessed by the Independent Imaging Evaluation Committee ( ORR), clinical benefit rate (CBR), objective duration of response (DOR) and safety.

    A total of 361 subjects were enrolled in the trial.
    They were 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 for 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.
    The results of the study show that for patients with HR-positive and HER2-negative advanced breast cancer who have previously received endocrine therapy, receiving SHR6390 combined with fulvestrant versus placebo combined with fulvestrant can significantly prolong the progression-free survival of patients.

    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.
    dxy.
    cn/v5/home)

    Image source: Insight database (https://db.
    dxy.
    cn/v5/home)

    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.
    In addition, 6 generic drugs of this product were reported on the market.
    Public data shows that the global sales of similar products in 2019 are approximately US$6.
    021 billion.

    The competitive landscape of domestic CDK4/6 inhibitors in research new drugs:

    Image source: Insight database (https://db.
    dxy.
    cn/v5/home)

    Image source: Insight database (https://db.
    dxy.
    cn/v5/home)
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