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    DRUG:

    Hanbeitai (bevacizumab biosimilar)

    i
    Other names: HLX-04, HLX04
    Associations

    News

    Trials
    Company:
    Eurofarma, Fosun Pharma
    Drug class:
    VEGF-A inhibitor
    Related drugs:
    Associations

    News

    Trials
    11ms
    A Clinical Study to Compare the Efficacy, Safety and Immunogenicity of HLX04 and Bevacizumab Combined XELOX or mFOLFOX6 in the First-line Treatment of mCRC (clinicaltrials.gov)
    P3, N=677, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    Avastin (bevacizumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Hanbeitai (bevacizumab biosimilar)
    12ms
    A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. (clinicaltrials.gov)
    P2, N=117, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Hetronifly (serplulimab) • HLX-53 • Hanbeitai (bevacizumab biosimilar)
    over1year
    First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial. (PubMed, Med)
    Serplulimab plus HLX04 and XELOX exhibits promising efficacy and is safe and tolerable in patients with treatment-naive mCRC.
    Clinical • P2/3 data • Journal • Metastases
    |
    MSI (Microsatellite instability)
    |
    Avastin (bevacizumab) • capecitabine • oxaliplatin • Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)
    over1year
    A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov)
    P2/3, N=568, Recruiting, Shanghai Henlius Biotech | Active, not recruiting --> Recruiting | N=114 --> 568 | Trial completion date: Jun 2025 --> Dec 2026 | Trial primary completion date: Nov 2024 --> Sep 2025
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • capecitabine • oxaliplatin • Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)
    over1year
    A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 With or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. (clinicaltrials.gov)
    P2, N=117, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial • Metastases
    |
    Hetronifly (serplulimab) • HLX-53 • Hanbeitai (bevacizumab biosimilar)
    over2years
    A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=643, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2023 --> Oct 2023
    Enrollment closed • Trial primary completion date • Combination therapy • Tumor mutational burden • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • ALK mutation • ROS1 mutation
    |
    carboplatin • pemetrexed • Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)
    over2years
    Phase 2 Study of the PD-1 Inhibitor Serplulimab plus the Bevacizumab Biosimilar HLX04 in Patients with Previously Treated Advanced Hepatocellular Carcinoma. (PubMed, Liver Cancer)
    The objective response rate was 30.0% (95% confidence interval [CI], 11.9-54.3) in group A and 14.3% (95% CI, 3.0-36.3) in group B. Median duration of response was not reached (95% CI, 3.3-not evaluable [NE]) in group A and was 9.0 months (95% CI, 7.9-NE) in group B. Median progression-free survival was 2.2 months (95% CI, 1.4-5.5) and 4.1 months (95% CI, 1.5-NE), and median overall survival was 11.6 months (95% CI, 6.4-NE) and 14.3 months (95% CI, 8.2-NE) in groups A and B, respectively. Serplulimab plus HLX04 showed a manageable safety profile and promising antitumor activity in patients with previously treated advanced HCC.
    P2 data • Journal • Metastases
    |
    Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)
    almost3years
    A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov)
    P2/3, N=114, Active, not recruiting, Shanghai Henlius Biotech | Phase classification: P3 --> P2/3
    Phase classification • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • capecitabine • oxaliplatin • Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)
    over3years
    A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=636, Recruiting, Shanghai Henlius Biotech | Trial completion date: Sep 2022 --> Mar 2024 | Trial primary completion date: Jun 2022 --> Feb 2023
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • ALK mutation • ROS1 mutation
    |
    carboplatin • pemetrexed • Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)
    over3years
    A Clinical Study to Evaluate Efficacy and Safety of HLX10 Combined With HLX04 and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov)
    P3, N=115, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | N=666 --> 115
    Enrollment closed • Enrollment change • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • capecitabine • oxaliplatin • Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)
    almost4years
    A Clinical Study to Compare the Efficacy, Safety and Immunogenicity of HLX04 and Bevacizumab Combined XELOX or mFOLFOX6 in the First-line Treatment of mCRC (clinicaltrials.gov)
    P3, N=677, Active, not recruiting, Shanghai Henlius Biotech | Trial completion date: Apr 2021 --> Apr 2024
    Trial completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    Avastin (bevacizumab) • oxaliplatin • Hanbeitai (bevacizumab biosimilar)
    4years
    A Clinical Study to Evaluate Efficacy and Safety of HLX10 Combined With HLX04 and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov)
    P3, N=666, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)