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    Home > Active Ingredient News > Antitumor Therapy > Hengrui Medicine's application for the listing of CDK 4/6 inhibitors has been accepted and R&D investment nearly 2...

    Hengrui Medicine's application for the listing of CDK 4/6 inhibitors has been accepted and R&D investment nearly 2...

    • Last Update: 2021-05-10
    • Source: Internet
    • Author: User
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    Source: Guanlan Pharmaceutical

    On April 27, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that Hengrui Medicine's Class 1 new drug CDK 4/6 inhibitor SHR6390 tablets had submitted a new drug marketing application and was accepted.
    It is worth mentioning that this product has recently been included in CDE as a breakthrough treatment product and is planned to be included in priority review.
    The indications are: combined with Fulvestrant for hormone receptor (HR) positive, human epidermal growth factor Treatment of recurrent or metastatic breast cancer that has progressed after endocrine therapy with negative body 2 (HER2).
    According to the announcement of Hengrui Medicine on April 26, up to now, the accumulated research and development expenses of SHR6390 related projects are about 269.
    94 million yuan.

    Screenshot source: CDE official website

    Screenshot source: CDE official website

    CDK 4/6 (cyclin-dependent kinase 4 and 6) is a key regulator that drives cell division.
    Studies have found that CDK 4/6 is overexpressed in many cancer cells, leading to uncontrolled cell division cycles and unlimited proliferation.
    Clinical studies have confirmed that more than half of breast cancer patients overexpress cyclin D (cyclin D), and most of them are HR-positive breast cancer patients.
    Because cyclin D directly acts on CDK 4/6, CDK 4/6 has become an important molecular target for patients with HR-positive metastatic breast cancer.

    SHR6390 is an oral, high-efficiency and selective small molecule CDK 4/6 inhibitor developed by Hengrui Medicine, which is a Class 1 new drug.
    It can selectively inhibit CDK 4/6 kinase activity, thereby blocking the CDK 4/6-retinoblastoma protein (Rb) signaling pathway, thereby inducing tumor cell G1 blockade, and selectively inhibiting the high expression of Rb Of tumor cells proliferate.
    Therefore, SHR6390 plays a decisive role in blocking the process of cells from G1 phase to S phase, thereby effectively inhibiting tumor cell proliferation, achieving the effect of anti-tumor and prolonging the survival of patients.

    On March 17, SHR6390 tablets were included in the CDE breakthrough treatment category announcement.
    The indications are: combined with fulvestrant for the treatment of HR-positive, HER2-negative recurrent or metastatic breast cancer that has progressed after endocrine therapy.
    On April 21, SHR6390 tablets were approved by the CDE to be included in the priority review and approval procedures for drugs included in the breakthrough treatment drug program.

    Screenshot source: CDE official website

    Screenshot source: CDE official website

    Public information shows that SHR6390 has reached the pre-designated superiority standard in a multi-center, randomized, controlled, double-blind phase 3 clinical study named SHR6390-III-301.
    The study was led 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 in the study.
    It aims to explore the HR-positive/HER2-negative localization of SHR6390 tablets combined with fulvestrant after previous endocrine therapy.
    Efficacy and safety in advanced or metastatic breast cancer.
    The results show that, compared with placebo combined with fulvestrant, receiving SHR6390 combined with fulvestrant can significantly prolong the progression-free survival of patients.

    It is reported that in addition to the second-line treatment of hormone receptor-positive breast cancer, SHR6390 is also undergoing key research on its application in advanced first-line related treatments.
    Among them, a phase 3 study of SHR6390 combined with aromatase inhibitors versus aromatase inhibitors in the treatment of HR-positive and HER2-negative advanced breast cancer is underway, and the enrolled patients are required to have not received systemic treatment in the advanced stage.
    This also shows that SHR6390 is also expected to benefit more breast cancer patients.

    Breast cancer is the most common cancer among women worldwide.
    The most common subtype is the HR positive/HER2 negative subtype, which accounts for 70% of the total number of breast cancer patients.
    Approximately 30% of patients diagnosed with HR-positive and HER2-negative early breast cancer are still at risk of cancer recurrence.
    At present, the combination therapy of CDK 4/6 inhibitors and endocrine drugs has become a new model for reversing the resistance of endocrine therapy, significantly improving the prognosis of patients with HR-positive advanced breast cancer.

    According to the announcement issued by Hengrui Medicine on April 26, the world’s approved CDK 4/6 inhibitors include palbociclib (trade name: Ibrance) developed by Pfizer and ribociclib (trade name: Novartis) developed by Novartis.
    Kisqali) and Eli Lilly and Company (Eli Lilly and Company) developed abemaciclib (trade name: Verzenio).
    Among them, Pfizer palbociclib and Eli Lilly and Company abemaciclib have been approved in China.
    The arrival of Hengrui Medicine SHR6390 is expected to bring new treatment options for breast cancer patients.

    attention [drug Mingkang Germany ] micro-channel public number

    [Medical attention Mingkang Germany ] ] micro-channel public number

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