Serplulimab
Phase 3Monoclonal antibody
Shanghai Henlius BiotechSerplulimab is a monoclonal antibody that works as a Programmed Cell Death Protein 1 Antagonist.[2] It is being investigated across 40 indications, with its most advanced program in Phase 3.[1]
Serplulimab is one of 671 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.
40
Indications
73
Total Trials
66
Active Trials
670
Competitors
Pipeline
Status by Indication[3][1]
Indication
Showing 10 of 40 indications
Competition
Competitive Landscape
414 competitors in Non-Small Cell Lung Cancer
#DrugCompanyPhaseTrials
1Serplulimab
Shanghai Henlius BiotechPhase 3
Enlonstobart
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Phase 3
TGRX-326
SShenzhen TargetRx Co., Ltd.
Phase 3
Remeron
OOrganon and Co
Preclinical
Aqupla
Jiangsu Simcere Pharmaceutical Co., Ltd.Preclinical
Ftorafur
TThe First Affiliated Hospital with Nanjing Medical University
Preclinical
Vibramycin
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Treatment
GSKPreclinical
PD-1 Inhibitors
BBioNTech US Inc.
Preclinical
Valemetostat Tosylate
Daiichi SankyoPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q4 2026
Phase 2Recruiting
Neoadjuvant Therapy
NCT07269782
Phase 2Recruiting
Locally-Advanced Rectal Cancer
NCT05731726
Phase 2Recruiting
Cervical Cancer
NCT06727617
Phase 2Recruiting
Necrosis
NCT06433869
Phase 2Not yet recruiting
Adjuvant Treatment
NCT06439550
Phase 2Active, not recruiting
Small Cell Lung Cancer
NCT05957510
Clinical
Trials by Indication[1]
Cervical Cancer6 trials
Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors
Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT06727617·134 enrolled
Show 3 more trials
Serplulimab for Locally Advanced Cervical Cancer
Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07340489·216 enrolled
Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer
Active, not recruiting·—·Phase 2·NCT06419673·240 enrolled
Non-Small Cell Lung Cancer5 trials
Show 2 more trials
Locally-advanced Rectal Cancer4 trials
Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)
Not yet recruiting·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 2·NCT07381400·128 enrolled
Gastric Cancer4 trials
Locally Advanced Colon Cancer3 trials
45 more indications
Gastric Adenocarcinoma2 trials
Neoadjuvant Therapy2 trials
Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer (SMARTi-RC01)
Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07134101·138 enrolled
Colorectal Cancer2 trials
Small Cell Lung Cancer2 trials
An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing
Not yet recruiting·—·Phase 1/2·NCT07141771·100 enrolled
Locally Advanced Colorectal Cancer2 trials
Total Neoadjuvant Therapy1 trial
Radiation Therapy1 trial
Triple-Negative Breast Cancer1 trial
First-line Treatment1 trial
Neoadjuvant Treatment1 trial
Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC
Not yet recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT07403435·22 enrolled
Carboplatin1 trial
Advanced Solid Tumors With Neuroendocrine Differentiation1 trial
Lung Cancer1 trial
Esophageal Cancer1 trial
Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06354218·50 enrolled
Bevacizumab1 trial
Pancreatic Cancer1 trial
Adenocarcinoma1 trial
Untreated Advanced NSCLC1 trial
Necrosis1 trial
Chemotherapy1 trial
Ascites1 trial
Adjuvant Treatment1 trial
Adjuvant Treatment With Serplulimab，Trastuzumab and SOX in the HER-2 Positive GC/GEJC
Not yet recruiting·TThe First Affiliated Hospital of Zhengzhou University·Phase 2·NCT06439550·42 enrolled
Metastatic Colorectal Cancer1 trial
Gastroesophageal Junction Adenocarcinoma1 trial
Advanced/Metastatic Solid Tumors1 trial
Treatment Failure1 trial
Advanced Malignant Solid Tumors1 trial
Advanced Solid Tumors1 trial
Rectal Cancer Patients1 trial
HR+/HER2- Breast Cancer1 trial
Gastric Neoplasms1 trial
Exploring the Efficacy of Ferrous Sulfate/Ferrous Succinate Combined With Serplulimab and SOX Regimen in Neoadjuvant Therapy for Gastric Cancer: A Prospective Cohort Study
Not yet recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT07872696·54 enrolled
Gastric or Gastroesophageal Junction Adenocarcinoma1 trial
Efficacy and Safety of Intraoperative Radiotherapy Combined With Serplulimab Plus Chemotherapy Versus Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single-Center, Randomized Controlled Study
Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07870798·68 enrolled
Locally Advanced Nasopharyngeal Carcinoma1 trial
Induction Chemotherapy Combined With Serplulimab Induction/Maintenance Therapy and Omission of Concurrent Chemotherapy in Locally Advanced Nasopharyngeal Carcinoma (UNION-NPC-001): A Multicenter, Open-Label, Randomized, Controlled, Phase III, Non-Inferiority Clinical Trial
Recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 3·NCT07177443·710 enrolled
SCLC, Extensive Stage1 trial
Pancreatic Ductal Adenocarcinoma1 trial
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Serplulimab. EMBL-EBI & Wellcome Sanger Institute.
- [4]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Programmed Cell Death Protein 1 Antagonist[2]
- Modality
- Monoclonal antibody[2]
- Highest Phase
- Phase 3[1]
- Company