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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:
    2d
    Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer (clinicaltrials.gov)
    P2, N=36, Active, not recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting --> Active, not recruiting | Trial completion date: May 2030 --> Dec 2030 | Trial primary completion date: May 2025 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab)
    3d
    SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases (clinicaltrials.gov)
    P2, N=102, Recruiting, First Affiliated Hospital of Zhejiang University | Not yet recruiting --> Recruiting
    Enrollment open • Mismatch repair • pMMR
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab)
    6d
    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
    15d
    Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P3, N=292, Recruiting, Zhejiang Cancer Hospital
    New P3 trial
    |
    Avastin (bevacizumab) • gemcitabine • albumin-bound paclitaxel • oxaliplatin • Hetronifly (serplulimab)
    17d
    Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer (clinicaltrials.gov)
    P1, N=100, Not yet recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
    New P1 trial • Checkpoint inhibition
    |
    Hetronifly (serplulimab) • alveltamig (ZG006)
    1m
    A prospective, single-arm study on the safety and efficacy of intrathecal administration of Serplulimab in the treatment of leptomeningeal metastasis from non-small cell lung cancer (ChiCTR2500108910)
    P=N/A, N=33, Not yet recruiting, Huashan Hospital Affiliated to Fudan University; Huashan Hospital Affiliated to Fudan University
    New trial
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • EGFR T790M • RET mutation • MET mutation
    |
    Hetronifly (serplulimab)
    1m
    A prospective, single-arm, single-center, exploratory study of slulizumab in cross-line treatment of recurrent extensive-stage small cell lung cancer (ES-SCLC) (ChiCTR2500108573)
    P=N/A, N=20, Not yet recruiting, Second Xiangya Hospital of CSU; Second Xiangya Hospital of CSU
    New trial
    |
    Hetronifly (serplulimab)
    1m
    A Multicenter, Phase II Study of Adaptive Radiotherapy Following EP Regimen Plus HLX10 (Serplulimab) for Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (ChiCTR2500108521)
    P2, N=80, Not yet recruiting, General Hospital of Ningxia Medical University; General Hospital of Ningxia Medical University
    New P2 trial
    |
    Hetronifly (serplulimab)
    1m
    Prospective, single center, single arm clinical study of neoadjuvant therapy with Serplulimab for stage II-IIIB non-small cell lung cancer (ChiCTR2500110056)
    P2, N=80, Recruiting, Zhejiang cancer Hospital; Zhejiang Cancer Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • ALK positive • ALK mutation • ROS1 positive
    |
    carboplatin • albumin-bound paclitaxel • pemetrexed • Hetronifly (serplulimab)
    1m
    ASTRIDE: To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC (clinicaltrials.gov)
    P3, N=200, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Sep 2025 --> Feb 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Hetronifly (serplulimab)
    2ms
    Efficacy and safety of immune checkpoint inhibitors for advanced squamous non-small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Front Immunol)
    Compared with chemotherapy, except for ipilimumab+chemo [HR = 0.92,95%CI: (0.59-1.40)], atezolizumab+chemo [HR = 0.88, 95%CI: (0.56-1.40)], and durvalumab+chemo [HR = 0.84, 95% CI: (0.52-1.40)], durvalumab+ tremelimumab+chemo [HR = 0...Cemiplimab [HR = 0.48, 95% CI: (0.34-0.67)] showed the best OS benefit...Sugemalimab+chemo provided the best survival benefit [HR = 0.34, 95% CI: (0.24-0.48)]. For PD-L1≥50% tumors, penpulimab showed excellent OS and PFS; for PD-L1 1-49% tumors, pembrolizumab+chemo and camrelizumab+chemo achieved the best OS and PFS, respectively; for PD-L1≥1% tumors, the tislelizumab+chemo and camrelizumab+chemo showed the best OS and PFS results, while for tumors with PD-L1 <1%, both nivolumab and serplulimab+chemo provided significant survival benefit...Ipilimumab+chemo had the highest incidence of adverse events (AEs) &lsqb;OR = 2.0, 95% CI:(1.5-2.7)]. https://www.crd.york.ac.uk/prospero/, identifier CRD420251027447.
    Clinical • Retrospective data • Review • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • Imjudo (tremelimumab-actl) • Libtayo (cemiplimab-rwlc) • Anniko (penpulimab) • Cejemly (sugemalimab) • Hetronifly (serplulimab)
    2ms
    Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013) (clinicaltrials.gov)
    P2, N=30, Completed, Fudan University | Recruiting --> Completed | Trial completion date: Dec 2025 --> Sep 2025
    Trial completion • Trial completion date
    |
    cisplatin • carboplatin • paclitaxel • Hetronifly (serplulimab)