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    DRUG CLASS:

    PD-L1-targeted antibody-drug conjugate

    Related drugs:
    9d
    A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=38, Recruiting, Shanghai Henlius Biotech | N=22 --> 38
    Enrollment change
    |
    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
    13d
    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
    15d
    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
    28d
    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
    28d
    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
    1m
    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
    1m
    SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=714, Recruiting, Seagen, a wholly owned subsidiary of Pfizer | N=315 --> 714 | Trial completion date: Apr 2028 --> Jan 2029 | Trial primary completion date: Apr 2027 --> Jan 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • PF-08046054
    2ms
    C5851005: A Study to Learn About the Study Medicine Called PF-08046054/SGNPDL1V Versus Docetaxel in Adult Participants with Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-small-cell Lung Cancer (NSCLC) (2025-521281-97-00)
    P2/3, N=246, Recruiting, Pfizer Inc.
    New P2/3 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    docetaxel • PF-08046054
    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
    3ms
    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 Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=399 --> 9 | Trial completion date: Sep 2029 --> Apr 2026 | Trial primary completion date: Sep 2028 --> Mar 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zumrad (sasanlimab)
    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