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    Home > Medical News > Latest Medical News > Introduced 15 months of Simcere Pharmaceuticals and submitted a new drug listing application for CDK 4/6 inhibitors

    Introduced 15 months of Simcere Pharmaceuticals and submitted a new drug listing application for CDK 4/6 inhibitors

    • Last Update: 2022-01-12
    • Source: Internet
    • Author: User
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    ArticleMedicine Guanlan

    On November 29, Simcere announced that its new drug marketing application (NDA) for injection of trilaciclib, an innovative drug for bone marrow protection, submitted to the National Medical Products Administration (NMPA), has been accepted
    This is a CDK 4/6 inhibitor introduced by Simcere from G1 Therapeutics for US$170 million

    took 15 months from the introduction to the submission of the NDA .

    Although many targeted therapies and immunotherapies have shown good curative effects in the treatment of various cancers, for many patients, chemotherapy is still one of the main means to control the development of tumors
    One of the most common side effects of chemotherapy is bone marrow suppression.
    Because bone marrow stem cells are killed by chemotherapy drugs, it can lead to serious consequences such as anemia, neutropenia or thrombocytopenia

    This side effect has a wide range of effects on the treatment experience and prognosis of patients


    Trirazilide is a short-acting CDK 4/6 inhibitor.
    It reduces the replication burden of bone marrow hematopoietic stem cells through a short-term G1 phase block, thereby alleviating the depletion of bone marrow hematopoietic stem cells

    In August 2020, G1 and Simcere Pharmaceuticals reached an exclusive license agreement of US$170 million, and Simcere Pharmaceuticals obtained the development and commercialization rights of this innovative therapy for all indications in the Greater China region


    According to Simcere’s press release, the first indication applied for Trirazil in China is: preventive use in patients with extensive-stage small cell lung cancer receiving platinum-containing drugs combined with etoposide regimen to reduce chemotherapy-induced The incidence of bone marrow suppression
    The data supporting this listing application includes the results of multiple clinical studies conducted by Simcere and its partners in China and abroad

    Studies have confirmed that trirazilide has consistent pharmacokinetic (PK) characteristics and clinical benefit trends in Chinese patients and overseas patients, and no new safety signals have been found


    In the United States, Trirazil has been granted breakthrough therapy designation and priority review by the FDA, and has been approved by the FDA for marketing in February 2021.
    It is used to reduce the appearance of patients with extensive-stage small cell lung cancer when receiving certain types of chemotherapy.
    The frequency of bone marrow suppression


    The effectiveness of trirazilide is supported by 3 randomized, double-blind, placebo-controlled studies in patients with extensive-stage small cell lung cancer
    Taken together, these studies randomly assigned 245 patients to receive intravenous infusion of trrazilide or placebo before chemotherapy

    In all three studies, patients who received trirazil had a lower chance of developing severe neutropenia than patients who received placebo

    Among those patients with severe neutropenia, on average, those who received trirazilide had a shorter duration of symptoms


    The FDA once pointed out in a press release that for patients with extensive-stage small cell lung cancer, protecting bone marrow function can help make their chemotherapy safer and allow them to complete the course of treatment as planned
    The approval of trirazilide will give patients a treatment option that can reduce the occurrence of a common harmful chemotherapy side effect


    In addition to small cell lung cancer, G1 and Simcere Pharmaceuticals have also initiated phase 3 clinical trials of Trirazil for colorectal cancer and triple-negative breast cancer.
    Outside China, neoadjuvant chemotherapy for breast cancer and second-line treatment for non-small cell lung cancer And exploratory research on the first-line treatment of bladder cancer is also underway


    Reference materials:

    [1] Simcere Pharmaceuticals announced that the world’s first comprehensive bone marrow-protecting drug trerazil had been accepted for marketing authorization.
    Retrieved Nov 30, 2021, from https://mp.

    [2] Simcere and G1 Therapeutics announced the signing of an exclusive license agreement for Trilaciclib products in the Greater China region.
    Retrieved Aug 03, 2020, from http:// FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy.
    Retrieved February 12, 2021, from https:// marrow-suppression-caused-chemotherapy

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