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    DRUG CLASS:

    PD-L1-targeted antibody-drug conjugate

    Related drugs:
    9d
    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=706, Recruiting, Shanghai Henlius Biotech | Enrolling by invitation --> Recruiting
    Enrollment status
    |
    EGFR (Epidermal growth factor receptor)
    |
    PD-L1 expression • EGFR expression
    |
    docetaxel • pimurutamab (HLX07) • HLX43
    12d
    HLX43-FIH101: A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=367, Enrolling by invitation, Shanghai Henlius Biotech | Recruiting --> Enrolling by invitation
    Enrollment status • First-in-human
    |
    PD-L1 expression
    |
    docetaxel • Hetronifly (serplulimab) • HLX43
    12d
    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=706, Enrolling by invitation, Shanghai Henlius Biotech | Not yet recruiting --> Enrolling by invitation
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor)
    |
    PD-L1 expression • EGFR expression
    |
    docetaxel • pimurutamab (HLX07) • HLX43
    23d
    SKB103 for Injection in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=277, Recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    23d
    A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy (clinicaltrials.gov)
    P2, N=102, Recruiting, Shanghai Henlius Biotech | N=72 --> 102
    Enrollment change
    |
    PD-L1 expression
    |
    HLX43
    1m
    HLX43-NSCLC201: A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=243, Recruiting, Shanghai Henlius Biotech | N=41 --> 243
    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
    2ms
    A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov)
    P1, N=8, Terminated, Pfizer | Active, not recruiting --> Terminated; The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns
    Trial termination
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zumrad (sasanlimab)
    2ms
    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=190, Recruiting, Shanghai Henlius Biotech | N=130 --> 190
    Enrollment change
    |
    PD-L1 expression
    |
    HLX43
    2ms
    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
    3ms
    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
    3ms
    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
    3ms
    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