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    Home > Medical News > Latest Medical News > Qilu Ruige CDK2/4/6 inhibitor RGT-419B was reported for the first time in China

    Qilu Ruige CDK2/4/6 inhibitor RGT-419B was reported for the first time in China

    • Last Update: 2022-05-29
    • Source: Internet
    • Author: User
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    On February 11, CDE's official website showed that Qilu Ruige's CDK2/4/6 inhibitor RGT-419B was declared for clinical use in China for the first time
    .
    On December 28, the drug was just approved by the FDA for clinical use

    .

    RGT-419B is a next-generation CDK2/4/6 small molecule inhibitor with an optimized kinase activity profile
    .
    It is expected to improve the safety profile of currently approved CDK4/6 inhibitors and overcome resistance to these inhibitors, which are used in combination with endocrine therapy for pre-/post-menopausal hormone receptor-positive (HR+) ), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer

    .

    In cell model experiments, RGT-419B showed single-agent activity and greater inhibition of ER+ tumor cell growth than abemaciclib and palbociclib
    .
    In ER+ breast cancer cells resistant to currently approved CDK4/6 inhibitors, RGT-419B showed complete inhibition of cancer cell proliferation

    .
    In these experiments, the inhibitory effect of RGT-419B on tumor cells was further enhanced when combined with a selective estrogen receptor degrader or a PI3K signaling pathway inhibitor

    .

    As a single agent and in combination with other approved therapies, RGT-419B will initially be developed for the treatment of patients with HER2-, ER+ breast cancer 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 previously treated with CDK4/6 inhibitors are becoming a larger, clinically meaningful unmet medical need

    .
    The clinical development program for RGT-419B will address this resistance to CDK4/6 and other hormone receptor modulating therapies, providing new opportunities to improve survival and quality of life for patients with advanced breast cancer

    .

    RGT-419B is the first of many innovative oncology drugs in development by Riage Pharma
    .
    Founder and CEO Dr.
    Xiayang Qiu said: "This milestone marks the successful entry of Ruige Medicine into the field of oncology treatment

    .
    We have found the best selectivity for multiple CDKs through our self-developed AI-assisted new drug development CARD platform.
    , successfully advancing innovative drugs into clinical development in the U.
    S.

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

    HER2-/HR+ breast cancer is the most common type of breast cancer
    .
    Globally, breast cancer is one of the most common cancers, affecting approximately 2.
    3 million women in 2020, and is the leading cause of cancer-related death in women

    .
    In China, breast cancer ranks fourth among solid tumor types, with more than 400,000 new cases each year

    .
    Breast cancer imposes a huge medical burden on patients in China and around the world, and has a huge negative impact on patients and their families

    .

    Regor Therapeutics is a clinical-stage biopharmaceutical high-tech company
    .
    Since its establishment three and a half years ago, with its AI-assisted new drug R&D CARD platform, it has locked in the targets of the pharmaceutical industry and developed innovative drugs with clinical differentiation advantages

    .
    The company focuses on the three major therapeutic areas of oncology, immunity and metabolism.
    Currently, there are 3 new drugs entering the clinical stage.
    RGT-075 is the fastest progressing one.
    It belongs to the small molecule GLP-1R agonist and has entered the phase II clinical trial, which belongs to the world.
    first tier

    .
    On December 10, 2021, Eli Lilly and Ruige Medicine reached a cooperation agreement for up to US$1.
    5 billion to jointly develop new drugs in the field of metabolism.
    The key project is RGT-075 for diabetes and obesity

    .

    Ruige pharmaceutical official website pipeline

    However, in early February, Pfizer sued the two founders of Rui Ge Medicine, accusing them of stealing the company's trade secrets while working at Pfizer, arguing that the drug launched by the defendant company was "strikingly similar" to Pfizer, and applied for a patent
    .
    At present, the lawsuit has been accepted by the U.
    S.
    federal court in Connecticut

    .
    The focus of the lawsuit is the GLP-1R small molecule agonist RGT-075, and Pfizer also has a similar drug PF-06882961

    .
    Rui Ge said that the company believes that the lawsuit is completely unfounded and will vigorously defend itself

    .

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