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    Home > Medical News > Medicines Company News > U.S. FDA approves Eglin's EG-007 to enter Phase III pivotal clinical trial

    U.S. FDA approves Eglin's EG-007 to enter Phase III pivotal clinical trial

    • Last Update: 2021-08-28
    • Source: Internet
    • Author: User
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    On August 10, 2021, Shenzhen Evergreen Pharmaceutical Co.
    , Ltd.
    announced that its innovative drug candidate EG-007 has been approved by the U.
    S.
    Food and Drug Administration (FDA) to carry out combined use with targeted drugs and anti-PD-1 antibody drugs A pivotal phase III clinical trial for the treatment of advanced endometrial cancer
    .


    The main goal of this clinical trial is to increase the response rate/effectiveness of immunotherapy in patients with advanced endometrial cancer by combining with EG-007


    The FDA agrees that EG-007 is aimed at patients with advanced endometrial cancer with non-microsatellite high instability (MSI-H) or mismatch repair defect (dMMR), who have progressed after previous systemic treatment and are not suitable for curative surgery or In the case of radiotherapy, phase III clinical trials are carried out
    .


    The main efficacy outcome indicators are progression-free survival (PFS), overall survival (OS) assessment, objective response rate (ORR) and duration of response (DOR)


    Dr.
    Changqing Li, Chief Medical Officer of Eglin Pharmaceuticals, said: "This is a key global multi-center phase III clinical trial
    .


    The US FDA has twice discussed this phase III clinical trial program with us twice


    Dr.
    Du Xin, Chief Operating Officer of Eglin Pharmaceuticals, said: "The FDA's approval of the Phase III clinical trial of EG-007 is a high recognition of our EG-007 project.
    Shenzhen Eglin Pharmaceutical Co.
    , Ltd.
    will promote the development of Phase III clinical trials as soon as possible.
    Strive to push EG-007 into the market as soon as possible and bring new hope to patients with advanced endometrial cancer
    .


    "

           About Eglin Pharmaceutical

           Shenzhen Evergreen Pharmaceutical Co.
    , Ltd.
    is an innovative pharmaceutical company founded by many former FDA senior review officers and more than ten former multinational pharmaceutical company executives.
    It focuses on the research and development of therapeutic drugs with urgent clinical needs, focusing on innovative drugs For the clinical research, development and commercialization of the company, three US FDA clinical trial approvals have been obtained in 2020
    .


    In March 2021, Eglin Pharmaceuticals coordinated a number of institutional investors and completed a 100 million yuan A round of financing


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