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    Home > Medical News > Latest Medical News > A new adaptation application for the treatment of first-line squamous non-small cell lung cancer patients in the form of a single-line squamous single-celled injection in a joint form with Gissithambin has been accepted.

    A new adaptation application for the treatment of first-line squamous non-small cell lung cancer patients in the form of a single-line squamous single-celled injection in a joint form with Gissithambin has been accepted.

    • Last Update: 2020-09-04
    • Source: Internet
    • Author: User
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    Introduction: The National Drug Administration (NMPA) has officially accepted applications for new adaptations (sNDA) for first-line treatment of squamous non-small cell lung cancer (NSCLC) with the innovative PD-1 inhibitor Dabershu® (Sndili monoantigen injection) jointly developed by both parties.
    , August 12, 2020 /A.M./-- Xinta Biopharmaceuticals, a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for major diseases such as tumors, metabolic diseases, autoimmunity, today and Lilly Pharmaceuticals (NYSE: LLY) Announced: The National Drug Administration (NMPA) has officially accepted applications for new adaptations (sNDA) for the first-line treatment of squamous non-small cell lung cancer (NSCLC) with the innovative PD-1 inhibitor Dabershu® (Sindili monoantigen injection) jointly developed by both parties.
    , NMPA formally accepted a new adaptation application for non-scaly NSCLC first-line treatment on 23 April 2020 from Dabershu® (Syndili monoantigen injection).
    The adaptive application is based on a randomized, double-blind, Phase III controlled clinical study (ORIENT-12) - Dabershu® (Syndili monoantigen injection) or placebo combined option ® (Gisithamin) and platinum for advanced or metastasis scaly NSCLC first-line therapy.
    Based on an analysis conducted by the Independent Data Monitoring Board (IDMC), Dabershu® (Syndicate monoantigen injections) combined with Gissytabin and platinum contrast placebos combined with Gistabin and Platinum, significantly extending progress-free lifetime (PFS) to meet pre-set pro-effects standards.
    safety characteristics are consistent with previously reported ® of the Dabershu ® (Cindili monoanti-injection) study, with no new safety signals.
    detailed research data will be published in subsequent international conferences and journals. Professor Zhou Caishu, director of oncology at Shanghai Lung Hospital and lead researcher of the
    ORIENT-12 study, said: "We are very pleased to see that the Daboshu® (Syndicate monoantigen injection) study has reached the preset main research endpoint.
    scaly NSCLC patients still have large unsoolvented medical needs, ORIENT-12 research is the world's first to prove that PD-1 antibody combined with gissythampan and platinum can significantly improve the first-line scaly NSCLC patients without progression survival benefits of randomized double-blind control study, has important clinical significance. Dr. Zhou Hui, Vice President, Biomedical Science and Strategic Oncology Department,
    " said, "This is the second NSCLC randomized, double-blind, phase 3 study after the ORIENT-11 study (first-line non-scaly NSCLC study, NCT03607539) to reach the end of the main study, and the second phase NSCLC new adaptation application for Cinda Bio.
    the application was accepted by the NMPA, meaning ® significant progress has been made in the layout of the Dabershu ® (Syndili monoanti-injection) in the first-line NSCLC field.
    we will actively cooperate with regulators to promote the early approval of the condition and provide more treatment options for first-line scaly NSCLC patients as soon as possible.
    Lilly and Xinda Bio are working together to bring internationally quality anti-tumor drugs to cancer patients in China," said Dr. Wang Li, Senior Vice President, Drug Development and Medical Affairs Center, Lilly China.
    Dabershu® (Syndili monoantigen injection) as the first fruit of the cooperation between the two sides, following the inclusion in the National Health Insurance Directory for relapse or refraction of classic Hodgkin's lymphoma treatment, the registration of non-small cell lung cancer new adaptation application is Another important milestone in the field of cancer treatment of Dabsch ® (Syndili single anti-injection).
    ORIENT-12 study offers new combination chemotherapy options for patients with squamous non-small cell lung cancer, and we look forward to bringing this new treatment to lung cancer patients in China as soon as possible.
    we will continue to work in-depth with Xinta Bio to further explore the potential of oncology immunotherapy and bring benefits to more patients.
    " about squamous NSCLC lung cancer is China's current morbidity and mortality rate ranked first malignant tumor.
    NSCLC accounts for about 80% to 85% of all lung cancers, and about 70% of NSCLC patients are diagnosed with locally advanced or metastasis tumors that are not suitable for root surgery.
    , a significant proportion of early NSCLC patients undergoing surgery also have relapses or distant metastasis and later die as the disease progresses.
    about 35% of patients with NSCLC in China were scaly NSCLCs that lacked the driving gene.
    for this population, treatment is still limited and there are significant unsealed medical needs.
    The ORIENT-12 study ORIENT-12 study is a randomized, double-blind, Phase III controlled clinical study evaluating the effectiveness and safety of late-stage or metastasis-scale NSCLC first-line treatments in Dabershu® (Cindili monoanti-injection) or placebo combined with gisectabin and platinum (ClinicalTrials.gov, NCT0362925).
    study endpoints were assessed by the Independent Imaging Review Board on progress-free survival (PFS) based on the RECISTv1.1 standard.
    end points include total lifetime (OS), security, and so on.
    the study, 357 subjects were randomly assigned to a group of 1:1, receiving 200mg of Dabschushu ®sindili monoantigen injections) or placebo combined with exercise ® (Gissithamin) And platinum therapy, once every 3 weeks, after 4 or 6 cycles of combined therapy, enter the Dabershu® (Syndili monoantigen injection) or placebo maintenance treatment phase, until the disease progresses, toxic inlerability or other circumstances requiring termination of treatment.
    the disease progression in the control group can be conditioned cross-® to Dabershu ® (Xindili monoantigen injection) single-drug treatment.
    study on ORIENT-11 is an assessment of Dabershu® (Cyndili monoantigen injection) or placebo combined libitaid® (injection with pemetroser) DNA) and platinum are used in randomized, double-blind, Phase III controlled clinical studies (ClinicalTrials.gov, NCT03607539) for the effectiveness and safety of first-line treatment of advanced or relapsed non-squamous non-small cell lung cancer.
    study endpoints were assessed by the Independent Imaging Review Board on progress-free survival (PFS) based on the RECISTv1.1 standard.
    end points include total lifetime (OS), security, and so on.
    the study included 397 subjects who were randomly assigned to a group of 2:1, receiving 200 mg of Dabschushu ® (Cyndili monoanti-injection) or placebo combined libita ® (injection with pyrithione dinatrena and platinum® Once every 3 weeks, after completing 4 cycles of treatment, enter the maintenance phase of Dabershu ® (Cyndili monoantigen injection) or placebo combined libita ® (injection with pyridoxine di sodium) until the disease progresses, toxic inlerability, or other conditions requiring termination of treatment.
    the disease progression in the control group can be conditioned cross-® to Dabershu ® (Xindili monoantigen injection) single-drug treatment.
    that the study had reached the end of its main study, NMPA had formally accepted the application for the new ® of Dabershu® (Syndili monoanti-injection) on 23 April 2020.
    About Dabershu ® (Syndili monoanti-injection) Dabershu® (Syndicate mono-injection) is an internationally quality innovative biologic drug developed jointly by Xinda Biopharmaceuticals and Lilly Pharmaceuticals in China.
    the first adaptation approved was relapsed/resuscipable classic Hodgkin's lymphoma, which was selected in the 2019 edition of the China Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of lymphoma.
    the 2019 Health Care National ®, Dabershu ® is the only PD-1 inhibitor that enters the national health care system.
    April 2020, NMPA officially accepted Dabershu ® (Cindili monoantigen injection) combined Libita ® (injection with pyrithrocytate di sodium) and platinum chemotherapy first-line treatment of non-scales Application for new adaptations for non-small cell lung cancer®® Phase III study of small cell lung cancer reaches the main research endpoint, and ORIENT-2 study of single-drug second-line treatment of advanced/metastatic esophageal squamous cancer reaches the main research endpoint of Dabershu® (Cindili monoanti-injection) single-drug second-line treatment; In August, NMPA officially accepted applications for new adaptations to Dabershu® (Syndicate Monoantigen Injection) Joint Allergy ® (Injection with Gissytabin) and Platinum chemotherapy for first-line treatment of squamous non-small cell lung cancer.
    Dabershu ® (Syndili monoantigen injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specificly binds to PD-1 molecules on the surface of T cells, blocking The PD-1/programmed death ligand ligand 1 (ProgrammedDeath-Ligand1, PD-L1) path, which causes tumor immunity, reactivates the anti-tumor activity of lymphocytes, thus achieving the goal of treating tumors.
    more than two dozen clinical studies, more than 10 of which are registered clinical trials, are currently under way to assess the anti-tumor effects of Syndication on a wide range of solid and blood tumors.
    Xinda Bio is also conducting clinical research on Xindili monoantigen injections worldwide.
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