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    Home > Active Ingredient News > Endocrine System > Hengrui SHR6390 intends to be included in the breakthrough therapy CDK4/6 inhibitor mixture...

    Hengrui SHR6390 intends to be included in the breakthrough therapy CDK4/6 inhibitor mixture...

    • Last Update: 2021-05-03
    • Source: Internet
    • Author: User
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    Recently, Hengrui Pharmaceutical's innovative drug SHR6390 tablets was included in the list of proposed breakthrough treatments by the Drug Evaluation Center of the National Medical Products Administration.
    The proposed indication is SHR6390 tablets combined with fulvestrant to treat hormone receptors that have progressed after endocrine therapy ( HR) positive, human epidermal growth factor receptor 2 (HER2) negative recurrent or metastatic breast cancer, the publication date ends on March 24.

    Source: CDE

    SHR6390 is an oral, high-efficiency and selective small molecule CDK4/6 inhibitor developed by Jiangsu Hengrui, which belongs to the first class of chemical drugs.
    Its 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 multi-center, randomized, controlled, double-blind phase III clinical study of breast cancer was conducted by Professor Xu Binghe from the Cancer Hospital of the Chinese Academy of Medical Sciences as the main investigator, and 42 centers across the country participated.
    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 compared with placebo combined with fulvestrant can significantly prolong the PFS (progression-free survival) of the patients.

    Introduction to CDK4/6 Inhibitors

    Introduction to CDK4/6 Inhibitors

    Cyclin Dependent Kinase (CDK) is a key kinase involved in cell cycle regulation.
    At the checkpoint of cells from G1 to S phase, retinoblastoma protein (Rb) needs to be phosphorylated and modified by CDK4/6.
    Abnormalities in this pathway can lead to continuous cell proliferation, which is related to cancer.
    CDK4/6 inhibitors can block the activity of CDK4/6 kinase, reduce the phosphorylation level of Rb protein, make it unable to release the transcription factor E2F, and inhibit the division and proliferation of cancer cells.

    CDK4/6 inhibitor approval status

    CDK4/6 inhibitor approval status

    In recent years, CDK4/6 inhibitors are rapidly changing the treatment pattern of HR+ and HER2- advanced breast cancer.
    The NCCN guidelines, ABC guidelines (International Consensus Guidelines for Advanced Breast Cancer) and other major domestic and foreign guidelines all use CDK4/6 inhibitors combined with endocrine therapy as the level I recommendation for the treatment of advanced breast cancer.
    At present, 4 CDK4/6 inhibitors have been approved globally, namely Pfizer’s Ibrance (palbociclib, piperacillin), Novartis’s Kisqali (ribociclib, rebociclib), and Eli Lilly’s Verzenio (abemaciclib, Abemaciclib).
    Besili) and G1 Therapeutics' Cosela (trilaciclib).
    Among them, Pfizer’s pipercillide (trade name: Aiboxin) and Eli Lilly’s Abbecillide (trade name: Vise) have been approved in China, and Hengrui’s SHR6390 is likely to become the third domestically listed CDK4/ 6 Inhibitors.

    Pfizer’s piperacillil no longer leads the way, CDK4/6 inhibitor melee is about to start

    Pfizer’s piperacillil no longer leads the way, CDK4/6 inhibitor melee is about to start

    As the first CDK4/6 inhibitor drug to be marketed, Pfizer's piperacillil has an obvious first-mover advantage.
    In 2020, pibacillil's global sales were 5.
    392 billion U.
    S.
    dollars, accounting for 77% of the entire market.
    In the domestic CDK4/6 inhibitor drug market, Pfizer's piperacillil is also the dominant player.
    In July 2018, piperacillil was approved for marketing in my country as the first CDK4/6 inhibitor drug.
    At present, it has benefited 350,000 patients in nearly 100 countries and regions around the world, including nearly 10,000 Chinese patients.

    It can be said that piperacillil dominates the CDK4/6 inhibitor market, and even if reboxilil and abecilil are listed afterwards, they have not been able to shake its market position.
    However, the Chinese compound patent of piperacillil will expire on January 10, 2023.
    By then, the army of generic drugs is about to land on the market.
    The outstanding situation of piperacillil in the market will be changed, and the melee of CDK4/6 inhibitors is also about to come.
    Turn on.

    In fact, on December 18, 2020, Qilu Pharmaceutical's 4 generic drugs, piperacillil capsules, have been approved for marketing by NMPA, which is the first imitation of this variety, and its indication is the first-line combination of aromatase inhibitors to treat postmenopausal patients.
    Female, HR+/HER2- locally advanced or metastatic breast cancer.
    In addition to Qilu Pharmaceutical, Simcere has also submitted a listing application.
    In addition, Fosun, Hisun and other companies have made generic drug layouts for this product.
    The following is the status of some domestic CDK4/6 inhibitors under development:

    (Source: CDE)

    In short, CDK 4/6 is a star target, and many companies are developing innovative drugs in the country.
    Soon, the melee of domestic CDK4/6 inhibitors (CDK4/6i) will begin.
    In the future, the prospects of CDK 4/6i in cancer treatment will not be limited to breast cancer.
    It is hoped that more progress and breakthroughs can be made in the research in the field of CDK 4/6i, which will benefit more cancer patients.

    Reference source:

    Reference source:

    1.

    1.
    style="text-indent:2em;margin-top:20px;"> 2.
    Finn RS, Crown JP, Lang I, et al.
    The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer ( PALOMA-1/TRIO-18): a randomised phase 2 study.
    The Lancet Oncology.
    2015;16(1):25-35.

    2.
    Finn RS, Crown JP, Lang I, et al.
    The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer ( PALOMA-1/TRIO-18): a randomised phase 2 study.
    The Lancet Oncology.
    2015;16(1):25-35.

    3.
    Rugo HS, Finn RS, Dieras V, et al.
    Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up.
    Breast Cancer Res Treat.
    2018;174(3):719-729.

    3.
    Rugo HS, Finn RS, Dieras V, et al.
    Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up.
    Breast Cancer Res Treat.
    2018;174(3):719-729.

    4.
    Im SA, Lu YS, Bardia A, et al.
    Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer.
    N Engl J Med.
    2019;381(4):307-316.

    4.
    Im SA, Lu YS, Bardia A, et al.
    Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer.
    N Engl J Med.
    2019;381(4):307-316.
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