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    Home > Active Ingredient News > Drugs Articles > Decei Pharma announced that the Phase Ib clinical trial application of ATG-008 combined with ATG-010 was approved in China for the treatment of diffuse large B-cell lymphoma

    Decei Pharma announced that the Phase Ib clinical trial application of ATG-008 combined with ATG-010 was approved in China for the treatment of diffuse large B-cell lymphoma

    • Last Update: 2021-11-14
    • Source: Internet
    • Author: User
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    Shanghai, China and Hong Kong, November 2, 2021-Deqi Pharmaceutical Co.
    , Ltd.
    ("Deqi Pharmaceutical Co.
    , Ltd.
    " Qi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
    HK) announced today that the National Medical Products Administration (NMPA) has approved ATG-008 (onatasertib) in combination with ATG-010 (selinexor) for the treatment of relapsed/refractory diffuse large An open phase Ib study on the dose exploration and safety of B-cell lymphoma (rrDLBCL)
    .

    The National Medical Products Administration (NMPA) has approved ATG-008 (onatasertib) combined with ATG-010 (selinexor) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) for dose exploration and safety open phase Ib Research

    The trial is in China with Sun Yat-sen University Cancer Center as the lead research center, and it is planned to be carried out in 10 domestic research centers
    .


    The study is divided into a dose exploration phase and a dose expansion phase.


    The trial is in China with Sun Yat-sen University Cancer Center as the lead research center, and it is planned to be carried out in 10 domestic research centers


    Professor Cai Qingqing, a professor at Sun Yat-sen University Affiliated Tumor Hospital, doctoral supervisor, and head of the Lymphoma Group of the Oncology Branch of the Guangdong Medical Association, said: “DLBCL is one of the most common types of non-Hodgkin’s lymphoma, about 30- 40% of patients will experience relapse or refractory
    .


    Patients with relapse and refractory have a poor prognosis and limited treatment options


    The main investigator is Professor Qingqing Cai, a professor at Sun Yat-sen University Affiliated Tumor Hospital, a doctoral supervisor, and the head of the Lymphoma Group of the Oncology Branch of the Guangdong Medical Association

    Dr.
    Mei Jianming, Founder, Chairman and CEO of Deqi Pharmaceuticals, said: “I am very pleased that the National Medical Products Administration has approved ATG-008 combined with ATG-010 in the treatment of rrDLBCL for the dose exploration and safety of the open phase Ib clinical study.
    For Deqi, this is undoubtedly a
    piece of good news of great significance.


    The two single drugs ATG-008 and ATG-010 not only have positive anti-tumor effects in their respective treatment regimens, especially ATG-010 has been used by the FDA for this The approval of the indications, the combined use of the two, will exert a 1+1>2 strong synergy in the treatment of rrDLBCL.


    Dr.


    The trial is a dose-exploring, open phase Ib clinical study aimed at treating adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) with ATG-008 (onatasertib) combined with ATG-010 (selinexor) Perform dose exploration and safety assessment
    .


    The primary study endpoint was to determine the MTD and RP2D of ATG-008 combined with ATG-010 in rrDLBCL, and the secondary study endpoint was tumor evaluation based on the revised Lugano lymphoma efficacy evaluation criteria (Cheson 2014)


    About Deqi Pharmaceutical

    About Deqi Pharmaceutical

    Deqi Pharmaceutical Co.
    , Ltd.
    (abbreviated as "Deqi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
    HK) is a leading R&D-driven biopharmaceutical company dedicated to providing the most advanced therapies and treatments for patients in Asia Pacific and even the world Tumors and other life-threatening diseases
    .


    Since its official operation in 2017, Deqi Pharmaceuticals has established a rich product pipeline that extends from pre-clinical to clinical stages through cooperative introduction and independent research and development


    Forward-looking statements

    Forward-looking statements

    The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
    .


    Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear



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