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    Home > Medical News > Medical Research Articles > China National Medical Products Administration Approves Baizean(R) for Second-Line or Third-Line Treatment of Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    China National Medical Products Administration Approves Baizean(R) for Second-Line or Third-Line Treatment of Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    • Last Update: 2022-01-26
    • Source: Internet
    • Author: User
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    BEIJING, China and CAMBRIDGE, Mass.
    , Jan.
    6, 2022 /PRNewswire/ -- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) is a science-based company A global biotechnology company focused on developing innovative, affordable medicines designed to improve outcomes and improve access to medicines for patients around the world

    .
    The company announced today that the China National Medical Products Administration (NMPA) has approved BeiGene's anti-PD-1 antibody drug Baizean®
    ( tislelizumab injection) for locally advanced or metastatic non-small cell lung cancer Second- or third-line therapy for patients with NSCLC
    .
    In March 2021, the NMPA accepted the marketing application (sBLA) for this new indication

    .
     

    Dr.
    Xiaobin Wu, President, Chief Operating Officer and General Manager of BeiGene China, said: "The approval of
    Baizean® confirms our commitment to continue to bring innovative and impactful treatments to patients
    .
    Zean®
    has been approved for six indications in China, and many patients are expected to benefit from this innovative drug
    .

    In China, our science-based commercialization team has nearly 3,000 people, and they are working hard to bring Bai Zean® To bring more patients who may benefit from this important immunotherapy
    .
    With the deepening of our strategic cooperation with Novartis, we look forward to continuing to improve
    the global drug availability of Baizean and to further explore its therapeutic
    potential
    .
    "

    Ben Yong, MD, Chief Medical Officer of BeiGene Solid Tumors, said: "This is the third lung cancer approval for Baizean in China and another important milestone for Baizean .
    ® can be used for first-line, second- or third-line treatment of NSCLC .
    This approval is based on the positive results of a global clinical trial
    RATIONALE

    303, which will make Baizean® an important treatment option for Chinese patients .
    Zean® has an extensive global clinical development program, including 13 Phase 3 trials and 4 pivotal Phase
    2 trials, and is providing increasing clinical evidence for its efficacy and safety in multiple cancer types establish the impact of its treatment .
    "


    Zhou Caicun, MD, director of the Department of Oncology, Shanghai Pulmonary Hospital, director of the Institute of Oncology, Tongji University School of Medicine, and principal investigator of the trial, said: "In this global Phase 3 clinical trial, Baizean® significantly prolonged the previous clinical trial.
    The overall survival of previously treated NSCLC patients is well tolerated

    .
    The news of the NMPA approval of
    Baizean® is encouraging, and we hope that this immunotherapy drug can be an unmet treatment in the second or third line of NSCLC.
    New assistance is required

    .

    The approval of Bazaar is based on the clinical results of a randomized, open-label, global Phase 3 clinical trial, RATIONALE 303 (NCT03358875), which was designed to evaluate Bazaar versus docetaxel for the treatment of Efficacy and safety in patients with second- or third-line locally advanced or metastatic NSCLC with disease progression after prior platinum-containing chemotherapy
    .
    The trial enrolled 805 patients in 10 countries in Asia, Europe, the Americas and Oceania, who were randomized 2:1 to either berzean
    or docetaxel
    .

    BeiGene announced in November 2020 that the trial met its primary endpoint of overall survival (OS) in a planned interim analysis, as judged by the Independent Data Monitoring Committee (IDMC)
    .
    Bazaar®
    was generally well tolerated, consistent with known safety risks in previously reported results across tumor types, and no new safety warnings were identified
    .
    BeiGene presented results of the trial's interim analysis in April 2021 at the American Association for Cancer Research (AACR) annual meeting

    .

    About Non-Small Cell Lung Cancer

    Lung cancer is the second most common cancer type worldwide and the leading cause of cancer-related death [1]
    .
    Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancer cases and is usually diagnosed at an advanced stage
    [2]
    .
    The five-year survival rates of patients with stage IIIB and stage IV NSCLC after treatment are 5% and 2%, respectively
    [3]
    .
    In China, the incidence of lung cancer continues to increase, with approximately 815,563 new cases in 2020
    [4],[5]
    .

    About Baizean® ( Tislelizumab Injection)

    Baizean® ( Tislelizumab Injection) is a humanized IgG4 anti-programmed death receptor-1 (PD-1) monoclonal antibody designed to minimize interaction with macrophages Fcγ receptor binding
    in.
    Preclinical data suggest that Fcγ receptor binding in macrophages subsequently activates antibody-dependent cell-mediated killing T cells, thereby reducing the antitumor activity of PD-1 antibodies

    .
    Bai Zean®
    is the first drug developed by BeiGene's immuno-oncology bioplatform and is currently undergoing single-agent and combination therapy clinical trials to develop a broad range of indications for solid tumors and hematological tumors
    .

    The National Medical Products Administration (NMPA) of China has approved Baizean for six indications, including full approval of Baizean in combination with chemotherapy for the treatment of patients with first-line advanced squamous non-small cell lung cancer (NSCLC), Baizean ® combined with chemotherapy for the treatment of patients with first-line advanced non-squamous NSCLC, Betadine® for the treatment of patients with second- or third-line locally advanced or metastatic NSCLC who have previously received platinum-containing chemotherapy, and the conditional approval of Betadine® For the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have undergone at least second-line systemic chemotherapy, failure of platinum-based chemotherapy with high PD-L1 expression, including locally advanced disease progression within 12 months of neoadjuvant or adjuvant chemotherapy or metastatic urothelial carcinoma (UC), and patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy .
    Full approval for the above conditional approved indications will be contingent upon the results of ongoing confirmatory randomized controlled clinical trials .


    In addition, three new-indication marketing applications for Baizean are under review by the NMPA Center for Drug Evaluation (CDE), including one for the treatment of previously treated, locally advanced unresectable or metastatic high-grade microsatellite instability Type (MSI-H) or mismatch repair deficient (dMMR) solid tumors, a treatment for locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) that has progressed or is intolerable after prior first-line standard chemotherapy patients and a new-indication marketing application for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)
    .

    The U.
    S.
    Food and Drug Administration (FDA) has accepted the Marketing Authorization Application for
    Bazaar® for the treatment of patients with unresectable, recurrent locally advanced or metastatic ESCC after prior systemic therapy
    .
    Under the Prescription Drug User Fee Act (PDUFA), the FDA has a target date of July 12, 2022 for a decision on the marketing application for
    Bazaar®
    .

    BeiGene has initiated or completed 17 registrational clinical trials of BeiGene® in China and globally , including 13 Phase 3 clinical trials and 4 pivotal Phase 2 clinical trials
    .

    In January 2021, BeiGene and Novartis entered into a cooperation agreement to authorize Novartis to develop, manufacture and commercialize Baizean® in North America, Europe and Japan
    .

    Bai Zean® has not yet been approved in countries or regions other than China
    .

    About the clinical research and development project of Baizean® ( Tislelizumab Injection)

    Clinical trials of Bazaar® ( Tislelizumab Injection) include:

    • Phase 3 clinical trial of the safety and efficacy of tislelizumab versus docetaxel in second- or third-line treatment of patients with non-small cell lung cancer (clinicaltrials.
      gov number: NCT03358875)
    • Phase 3 trial of tislelizumab versus salvage chemotherapy in patients with relapsed or refractory classical Hodgkin lymphoma (clinicaltrials.
      gov number: NCT04486391)
    • Phase 3 trial of tislelizumab in patients with locally advanced or metastatic urothelial carcinoma (clinicaltrials.
      gov number: NCT03967977)
    • Phase 3 trial of tislelizumab combined with chemotherapy versus chemotherapy in first-line treatment of patients with advanced squamous non-small cell lung cancer (clinicaltrials.
      gov number: NCT03594747)
    • Phase 3 trial of tislelizumab combined with chemotherapy versus chemotherapy in first-line treatment of patients with advanced non-squamous non-small cell lung cancer (clinicaltrials.
      gov number: NCT03663205)
    • Phase 3 clinical trial of tislelizumab combined with platinum-based doublet chemotherapy in patients with non-small cell lung cancer (clinicaltrials.
      gov number: NCT04379635)
    • Phase 3 trial of tislelizumab/placebo in combination with platinum and etoposide in patients with extensive-stage small cell lung cancer (clinicaltrials.
      gov number: NCT04005716)
    • Phase 3 trial of tislelizumab versus sorafenib in first-line treatment of patients with hepatocellular carcinoma (clinicaltrials.
      gov number: NCT03412773)
    • Phase 2 trial of tislelizumab in previously treated patients with unresectable hepatocellular carcinoma (clinicaltrials.
      gov number: NCT03419897)
    • Phase 2 trial of tislelizumab in patients with locally advanced or metastatic urothelial bladder cancer (clinicaltrials.
      gov number: NCT04004221)
    • Phase 3 trial of tislelizumab versus chemotherapy in second-line treatment of patients with esophageal squamous cell carcinoma (clinicaltrials.
      gov number: NCT03430843)
    • Phase 3 clinical trial of tislelizumab combined with chemotherapy in first-line treatment of patients with esophageal squamous cell carcinoma (clinicaltrials.
      gov number: NCT03783442)
    • Phase 3 trial of tislelizumab versus placebo plus concurrent chemoradiotherapy in patients with localized esophageal squamous cell carcinoma (clinicaltrials.
      gov number: NCT03957590)
    • Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy in first-line gastric cancer (clinicaltrials.
      gov number: NCT03777657)
    • Phase 2 trial of tislelizumab in patients with relapsed/refractory classical Hodgkin lymphoma (clinicaltrials.
      gov number: NCT03209973)
    • Phase 2 clinical trial of tislelizumab in patients with MSI-H/dMMR solid tumors (clinicaltrials.
      gov number: NCT03736889)
    • Phase 3 trial of tislelizumab plus chemotherapy versus placebo plus chemotherapy in first-line treatment of patients with nasopharyngeal carcinoma (clinicaltrials.
      gov number: NCT03924986)

    About BeiGene Oncology

    BeiGene continuously promotes the research and development of best-in-class or first-in-class clinical drug candidates through independent research and development or in collaboration with like-minded partners, and is committed to providing influential, accessible and affordable medicines to patients around the world
    .
    The company's global clinical research and development team has about 2,750 people, and the team is still expanding

    .
    The team is currently supporting more than 90 ongoing or planned clinical studies worldwide (of which more than 70 clinical studies are underway) and has enrolled more than 14,000 patients and healthy subjects

    .
    BeiGene's own clinical development team plans and leads the development and expansion of the company's product pipeline, providing support and guidance for clinical trials covering more than 45 countries/regions around the world

    .
    The company particularly focuses on targeted therapy and tumor immunotherapy for hematological and solid tumors, and focuses on monotherapy and combination therapy

    .
    At present, three drugs independently developed by BeiGene have been approved for marketing:
    Baiyueze® (BTK inhibitor, which has been approved for listing in the United States, China, the European Union, the United Kingdom, Canada, Australia and other international markets), Baizean ® (anti-PD-1 antibody that can effectively avoid Fcγ receptor binding, approved for marketing in China) and Baihuize® ( PARP inhibitor, approved for marketing in China)
    .

    At the same time, BeiGene is also working with other innovative companies to jointly advance the research and development of innovative therapies to meet global health needs
    .
    In China, BeiGene is selling a number of oncology drugs licensed by Amgen, Bristol-Myers Squibb, EUSA Pharma, and Bio-Tech

    .
    The company is also working with companies including Amgen, Mirati Therapeutics, Seagen and Zymeworks to better address current unmet medical needs worldwide

    .

    In January 2021, BeiGene and Novartis announced a partnership that grants Novartis the right to develop, manufacture and commercialize BeiGene's anti-PD-1 antibody drug Baizean® (Tislelizumab Injection) in North America, Europe and Japan .
    ) rights

    .
    Since the collaboration agreement came into effect in February 2021, the two companies have reached key objectives of the collaboration, including the submission of the first New Drug Application (BLA) for tislelizumab outside of China, known as tislelizumab Antibiotic is used to treat patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic therapy, and the U.
    S.
    Food and Drug Administration (FDA) has accepted the new drug marketing application

    .
    Under the Prescription Drug User Fee Act (PDUFA), the FDA target date for a decision is July 12, 2022

    .
    In addition, the two parties are working closely together to carry out launch preparation activities, prepare other BLA submissions for tislelizumab as planned, and explore combination therapies for tislelizumab and their respective product portfolios and pipelines

    .
    Building on the progress of their current collaboration and their shared commitment to bring innovative therapies to more patients, the parties have entered into a new agreement to collaborate on the development, production and commercialization of BeiGene's TIGIT inhibitor, ociperlimab

    .

    About BeiGene

    BeiGene is a science-based global biotechnology company focused on developing innovative, affordable medicines designed to improve outcomes and access to medicines for patients around the world
    .
    The company's extensive drug portfolio currently includes more than 40 clinical candidates

    .
    The company accelerates the development of diversified and innovative drug pipelines by strengthening independent research and development capabilities and cooperation

    .
    We are committed to comprehensively improving access to medicines for more than 2 billion people worldwide by 2030

    .
    BeiGene has built a team of approximately 8,000 people on five continents

    .
    For more information, please visit the official website
    style="vertical-align: inherit;"> .

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including regarding BeiGene's commitment to cancer patients, BeiGene® Statement on the potential for long-term survival benefit of second- or third-line therapy in patients with locally advanced or metastatic NSCLC, BeiGene's plan to collaborate with Novartis to bring Betadine to more patients worldwide, BeiGene 's announcement on Betadine Progress, anticipated clinical development, regulatory milestones and commercialization, and statements of BeiGene's plans, commitments, ambitions and goals mentioned under the subheadings "About BeiGene Oncology" and "About BeiGene"
    .
    Actual results may differ materially from forward-looking statements as a result of various important factors
    .
    These factors include the risk of: BeiGene's ability to demonstrate efficacy and safety of its drug candidates; clinical results of drug candidates that may not support further development or marketing approval; regulatory actions that may affect the initiation of clinical trials , timelines and progress, and drug marketing approvals; BeiGene’s ability to achieve commercial success with its marketed drugs and drug candidates (if approved); BeiGene’s ability to obtain and maintain intellectual property protections for its drugs and technologies; Jeshenzhou's reliance on third parties for drug development, manufacturing and other services; BeiGene's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products, and its ability to obtain further working capital to complete drug candidate development and achieve and maintain profitability ; Impact of the COVID-19 pandemic on BeiGene's clinical development, regulatory, commercialization, and other businesses; discussed more fully in the "Risk Factors" section of BeiGene's most recent quarterly report on Form 10-Q various risks; and a discussion of potential risks, uncertainties and other important factors in BeiGene's subsequent filings with the SEC
    .
    All information in this press release is as of the date of this press release and BeiGene undertakes no duty to update such information unless required by law

    .

    references 

     


     

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