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    DRUG:

    Hetronifly (serplulimab)

    i
    Other names: HLX10, HLX 10, HLX-10
    Company:
    Eisai, Fosun Pharma, Intas, Lotus Pharmaceutical, PT Kalbe Farma
    Drug class:
    PD1 inhibitor
    Related drugs:
    3d
    SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases (clinicaltrials.gov)
    P2, N=51, Recruiting, First Affiliated Hospital of Zhejiang University | N=102 --> 51
    Enrollment change • Mismatch repair • pMMR
    |
    MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab)
    5d
    Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Sun Yat-sen University
    New P2 trial • IO biomarker
    |
    Fruzaqla (fruquintinib) • Hetronifly (serplulimab)
    5d
    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
    16d
    Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, Xijing Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • Hetronifly (serplulimab)
    19d
    Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC (clinicaltrials.gov)
    P2, N=46, Recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab) • TheraCIM (nimotuzumab)
    23d
    SCAR: Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Zhejiang University | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab) • celecoxib oral
    23d
    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
    25d
    FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer (clinicaltrials.gov)
    P4, N=42, Not yet recruiting, Ye Xu
    New P4 trial • Tumor mutational burden • pMMR
    |
    MSI (Microsatellite instability)
    |
    5-fluorouracil • oxaliplatin • Fruzaqla (fruquintinib) • leucovorin calcium • Hetronifly (serplulimab)
    25d
    NAPTSOX24: Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Zekuan Xu | Trial primary completion date: May 2025 --> Jan 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    oxaliplatin • Hetronifly (serplulimab) • Zadaxin (thymalfasin)
    30d
    Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: a prospective clinical trial. (PubMed, BMC Med)
    Neoadjuvant serplulimab, SOX, and thymalfasin produced encouraging pathological response, substantial nodal clearance, and an acceptable safety profile in stage III G/EGJ adenocarcinoma. Peripheral immune and transcriptomic profiling are consistent with a hypothesis in which thymalfasin may help preserve and coordinate systemic antitumor immunity without excessive toxicity. These findings warrant further larger randomized trials.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD69 (CD69 Molecule)
    |
    oxaliplatin • Hetronifly (serplulimab) • Teysuno (gimeracil/oteracil/tegafur) • Zadaxin (thymalfasin)
    1m
    FANLUNG-2：The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, Fudan University
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • MET exon 14 mutation • RET mutation • MET mutation • KRAS G12
    |
    5-fluorouracil • Hetronifly (serplulimab)
    1m
    Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC (clinicaltrials.gov)
    P2, N=22, Not yet recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    New P2 trial
    |
    cisplatin • carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab)