^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    HLX43

    i
    Other names: HLX43, HLX 43, HLX-43, YL222, YL-222
    Associations

    News

    Trials
    Company:
    Fosun Pharma, Shanghai Henlius Biotech, MediLink
    Drug class:
    Topoisomerase I inhibitor, PD-L1-targeted antibody-drug conjugate
    Related drugs:
    Associations

    News

    Trials
    4d
    HLX43-NSCLC201: Testing HLX43 in Advanced Lung Cancer (Non-Small Cell): A Global Safety and Effectiveness Study (2025-523803-31-00)
    P1/2, N=22, Not yet recruiting, Shanghai Henlius Biotech Inc.
    New P1/2 trial
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • EGFR mutation • MET exon 14 mutation
    |
    HLX43
    6d
    Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer. (clinicaltrials.gov)
    P2, N=180, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial • Checkpoint inhibition
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Hetronifly (serplulimab) • HLX43
    19d
    A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2/3, N=671, Not yet recruiting, Shanghai Henlius Biotech
    New P2/3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    PD-L1 expression • EGFR expression
    |
    docetaxel • pimurutamab (HLX07) • HLX43
    19d
    A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    HLX43
    24d
    A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=167, Recruiting, Shanghai Henlius Biotech | N=90 --> 167 | Trial completion date: Jul 2028 --> Jan 2029
    Enrollment change • Trial completion date
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07) • HLX43
    2ms
    A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (clinicaltrials.gov)
    P2, N=60, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR negative
    |
    Hetronifly (serplulimab) • HLX43
    2ms
    A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=126, Not yet recruiting, Shanghai Henlius Biotech
    New P1/2 trial
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • BRAF wild-type
    |
    Hetronifly (serplulimab) • pimurutamab (HLX07) • HLX43
    3ms
    A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    HLX43
    4ms
    A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    Hetronifly (serplulimab) • HLX43
    4ms
    HLX43-CC201: A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors (clinicaltrials.gov)
    P2, N=130, Recruiting, Shanghai Henlius Biotech | N=60 --> 130
    Enrollment change
    |
    HLX43
    4ms
    A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=340, Recruiting, Shanghai Henlius Biotech | N=174 --> 340
    Enrollment change
    |
    DDX5 (DEAD-Box Helicase 5)
    |
    PD-L1 expression
    |
    docetaxel • Hetronifly (serplulimab) • HLX43
    4ms
    A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    Hetronifly (serplulimab) • HLX43