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    DRUG:

    Hetronifly (serplulimab)

    i
    Other names: HLX10, HLX 10, HLX-10
    Company:
    Fosun Pharma, Intas, Lotus Pharmaceutical, PT Kalbe Farma
    Drug class:
    PD1 inhibitor
    Related drugs:
    15h
    Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study) (clinicaltrials.gov)
    P2, N=128, Not yet recruiting, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    New P2 trial • pMMR
    |
    MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Hetronifly (serplulimab)
    3d
    TAS-102 plus Fruquintinib or TAS-102 plus Fruquintinib in combination with Chidamide and Serplulimab as third-line and beyond treatment for metastatic colorectal cancer：A multicenter, randomized, two-arm clinical trial (ChiCTR2500115578)
    P4, N=64, Not yet recruiting, The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University
    New P4 trial
    |
    Fruzaqla (fruquintinib) • Epidaza (chidamide) • Lonsurf (trifluridine/tipiracil) • Hetronifly (serplulimab)
    3d
    A clinical study of carboplatin/albumin paclitaxel combined with PD-L1 inhibitor as neoadjuvant therapy for resectable Cervical Esophageal Squamous Cell Carcinoma (ChiCTR2500114965)
    P2, N=30, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab)
    3d
    Neoadjuvant immunotherapy with or without chemotherapy and minimally invasive esophagectomy in elderly patients for locally advanced esophageal squamous cell carcinoma: A prospective, single-arm, multicenter phase II clinical study (ChiCTR2500111929)
    P2, N=62, Recruiting, Shanghai Geriatric Medical Center; Shanghai Geriatric Medical Center
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    cisplatin • albumin-bound paclitaxel • Hetronifly (serplulimab)
    3d
    A Single-arm, Multi-center, Open-label Phase II Study to Investigate the Efficacy and Safety of Serplulimab in Combination with Chemotherapy in First-line Treatment of Pulmonary Neuroendocrine Carcinoma (ChiCTR2500113228)
    P2, N=162, Recruiting, PLA General Hospital; PLA General Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • ALK rearrangement
    |
    carboplatin • etoposide IV • Hetronifly (serplulimab)
    3d
    Phase I/II clinical study of SYS6043 combined with PD-1/PD-L1 inhibitor ± chemotherapy in the treatment of advanced solid tumor participants (ChiCTR2500112838)
    P1/2, N=622, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P1/2 trial
    |
    cisplatin • carboplatin • gemcitabine • Tevimbra (tislelizumab-jsgr) • pemetrexed • etoposide IV • Hetronifly (serplulimab) • Enshuxing (enlonstobart)
    6d
    Neoadjuvant serplulimab and SOX chemotherapy for locally advanced gastric cancer: pathological responses and systemic immune signatures from a phase II trial. (PubMed, Front Immunol)
    The identification of non-invasive, blood-based immune biomarkers may help guide future patient selection and therapeutic optimization. The ongoing phase III trial (NCT04139135) will validate the efficacy of this perioperative immunochemotherapy strategy in LAGC.
    P2 data • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IL1B (Interleukin 1, beta)
    |
    Hetronifly (serplulimab)
    11d
    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
    12d
    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
    12d
    A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study (clinicaltrials.gov)
    P2, N=50, Recruiting, Fudan University | Not yet recruiting --> Recruiting | Trial completion date: Aug 2026 --> Aug 2027 | Trial primary completion date: Feb 2026 --> Dec 2026
    Enrollment open • Trial completion date • Trial primary completion date • Tumor mutational burden • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    BRAF mutation • RAS wild-type
    |
    Fruzaqla (fruquintinib) • Hetronifly (serplulimab)
    18d
    A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer (clinicaltrials.gov)
    P2, N=30, Recruiting, First Affiliated Hospital of Wenzhou Medical University
    New P2 trial
    |
    MSI (Microsatellite instability) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    Avastin (bevacizumab) • capecitabine • oxaliplatin • Hetronifly (serplulimab)
    19d
    Serplulimab for Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P2, N=216, Recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • albumin-bound paclitaxel • Hetronifly (serplulimab)