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    Home > Medical News > Medicines Company News > Ruige Pharmaceutical's new generation of CDK2/4/6 small molecule inhibitors received clinical approval in the U.S.

    Ruige Pharmaceutical's new generation of CDK2/4/6 small molecule inhibitors received clinical approval in the U.S.

    • Last Update: 2022-01-09
    • Source: Internet
    • Author: User
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    Recently, Regal Pharmaceuticals announced that it has obtained the approval of the U.
    S.
    Food and Drug Administration (FDA) to conduct clinical studies of a new generation of CDK2/4/6 small molecule inhibitor RGT-419B

    .
    RGT-419B is a new generation of CDK2/4/6 small molecule inhibitor with optimized kinase activity profile

    .
    It is expected to improve the safety of currently approved CDK4/6 inhibitors and overcome resistance to these inhibitors.
    These inhibitors are used in combination with endocrine therapy to treat premenopausal/postmenopausal hormone receptor positive (HR+ ), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer patients

    .
    In cell model experiments, RGT-419B showed single-drug activity, and compared with abemaciclib and palbociclib, it had a greater inhibitory effect on the growth of ER+ tumor cells

    .
    In ER+ breast cancer cells resistant to currently approved CDK4/6 inhibitors, RGT-419B showed complete inhibition of cancer cell proliferation

    .
    In these experiments, when RGT-419B is used in combination with a selective estrogen receptor degrader or PI3K signaling pathway inhibitor, its inhibitory effect on tumor cells is further enhanced

    .
    As a single agent and in combination with other approved therapies, RGT-419B will initially be developed to treat HER2-, ER+ breast cancer patients who have primary or acquired resistance to currently approved CDK4/6 inhibitors

    .
    With the widespread adoption of CDK4/6 inhibitors in clinical practice, refractory and relapsed patients who were previously treated with CDK4/6 inhibitors are becoming a larger and clinically significant unmet medical need

    .
    The clinical development project of RGT-419B will solve this resistance to CDK4/6 and other hormone receptor modulating therapies, and provide new opportunities for improving the survival and quality of life of patients with advanced breast cancer

    .
    RGT-419B is the first of many innovative oncology drugs being developed by Regal Pharmaceuticals

    .
    Founder and CEO Dr.
    Qiu Xiayang said: "This milestone marks the successful entry of Regal Pharmaceuticals into the field of tumor treatment

    .
    We have found the best choice for multiple CDKs through our self-developed AI-assisted new drug development CARD platform.
    , Successfully promoted innovative drugs to enter the clinical development stage in the United States

    .
    At the same time, we are very excited that this opportunity can bring new and differentiated treatment options to many breast cancer patients around the world

    .
    "
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