Serplulimab

Phase 3Monoclonal antibody

Serplulimab is a monoclonal antibody that works as a Programmed Cell Death Protein 1 Antagonist.[2] It is being investigated across 24 indications, with its most advanced program in Phase 3.[1]

Serplulimab is one of 532 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

531

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaActive, not recruiting

AscitesActive, not recruiting

Esophageal Squamous Cell CarcinomaActive, not recruiting

Nasopharyngeal CarcinomaActive, not recruiting

Lung CancerActive, not recruiting

Nasopharyngeal NeoplasmActive, not recruiting

Esophageal CancerActive, not recruiting

Gastric AdenocarcinomaActive, not recruiting

AdenocarcinomaActive, not recruiting

NecrosisActive, not recruiting

Gastroesophageal Junction AdenocarcinomaPhase 2

Active, not recruiting

AscitesPhase 2

Active, not recruiting

Esophageal Squamous Cell CarcinomaPhase 3

Active, not recruiting

Nasopharyngeal CarcinomaPhase 3

Active, not recruiting

Lung CancerPhase 2

Active, not recruiting

Nasopharyngeal NeoplasmPhase 2

Active, not recruiting

Esophageal CancerPhase 2

Active, not recruiting

Gastric AdenocarcinomaPhase 2

Active, not recruiting

AdenocarcinomaPhase 2

Active, not recruiting

NecrosisPhase 2

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Serplulimab

Shanghai Henlius Biotech

Phase 3

2 2

Halaven

Eisai

Preclinical

38 3

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 4

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 5

Adenocard

Astellas

Preclinical

1 6

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 7

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 8

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Avastin

Roche

Preclinical

4 10

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Gastric Cancer

NCT05585580

Phase 2Recruiting

Neoadjuvant Therapy

NCT07269782

Phase 2Recruiting

Locally Advanced

NCT06601309

Phase 2Recruiting

Locally-Advanced Rectal Cancer

NCT05731726

Phase 2Recruiting

Cervical Cancer

NCT06727617

Phase 2Recruiting

Necrosis

NCT06433869

Clinical

Trials by Indication[1]

Cervical Cancer6 trials

A Phase II Study of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Untreated Recurrent or Metastatic Cervical Cancer

Unknown status·SSichuan Cancer Hospital and Research Institute·Phase 2·NCT05444374·48 enrolled

Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT06727617·134 enrolled

Nituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer

Recruiting·FFujian Cancer Hospital·Phase 2·NCT06455072·37 enrolled

Show 3 more trials

Real-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancer

Unknown status·SShandong University··NCT05883670·118 enrolled

Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer

Active, not recruiting·—·Phase 2·NCT06419673·240 enrolled

Serplulimab for Locally Advanced Cervical Cancer

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07340489·216 enrolled

Non-Small Cell Lung Cancer5 trials

Serplulimab for Patients With Non-small Cell Lung Cancer (NSCLC) With TPS ≥ 50%: a Prospective, Single-center, Single-arm Phase 2 Study.

Unknown status·ZZhejiang Cancer Hospital·Phase 2·NCT06195683·23 enrolled

Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer

Recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT05766800·100 enrolled

Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer

Not yet recruiting·XXi Junjie·Phase 2·NCT07064876·25 enrolled

Show 2 more trials

A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2/3·NCT07318883·720 enrolled

Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer

Not yet recruiting·SShanghai Chest Hospital·N/A·NCT06580665·134 enrolled

Gastric Cancer4 trials

Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer

Recruiting·FFudan University·Phase 2·NCT05975749·114 enrolled

A Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer

Recruiting·RRenJi Hospital·Phase 2·NCT05769725·70 enrolled

Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

Recruiting·TTang-Du Hospital·N/A·NCT06128252·96 enrolled

Show 1 more trial

Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy

Recruiting·QQilu Hospital of Shandong University·Phase 2·NCT05585580·59 enrolled

Locally-advanced Rectal Cancer3 trials

Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer

Recruiting·ZZhejiang University·Phase 2·NCT05731726·50 enrolled

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

Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)

Recruiting·FFudan University·Phase 2·NCT07150949·138 enrolled

Pancreatic Cancer2 trials

JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure

Not yet recruiting·WWest China Hospital·Phase 1/2·NCT07175389·10 enrolled

A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)

Not yet recruiting·WWest China Hospital·Phase 3·NCT07336953·198 enrolled

38 more indications

Breast Cancer2 trials

NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.

Recruiting·HHenan Cancer Hospital··NCT06781281·709 enrolled

Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

Recruiting·HHenan Cancer Hospital·Phase 2·NCT06860529·357 enrolled

Gastric Adenocarcinoma2 trials

Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)

Recruiting·YYu jiren·Phase 2·NCT05872685·314 enrolled

Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma: A Randomized Phase 2 Investigator-Initiated Trial

Not yet recruiting·NNational Cancer Center, Japan·Phase 2·NCT07699939·136 enrolled

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

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT07269782·60 enrolled

Colorectal Cancer2 trials

FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer

Not yet recruiting·YYe Xu·Phase 4·NCT07446465·42 enrolled

Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer

Recruiting·FFudan University·Phase 2·NCT06521866·208 enrolled

Locally Advanced Colon Cancer2 trials

Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer

Recruiting·RRuijin Hospital·Phase 2·NCT06368141·56 enrolled

Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)

Unknown status·FFudan University·Phase 2·NCT05732493·120 enrolled

First-line Treatment1 trial

Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC

Not yet recruiting·TThe Central Hospital of Lishui City·N/A·NCT06364046·56 enrolled

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

Bevacizumab1 trial

Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients

Recruiting·SSun Yat-sen University·Phase 2/3·NCT06280495·156 enrolled

Carboplatin1 trial

Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)

Not yet recruiting·RRenJi Hospital·Phase 2·NCT07283692·46 enrolled

Nasopharyngeal Carcinoma1 trial

Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma

Not yet recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 3·NCT07177443·456 enrolled

Safety and Efficacy1 trial

Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment

Unknown status·GGuangdong Association of Clinical Trials·Phase 2·NCT05957510·36 enrolled

Locally Advanced1 trial

Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC

Recruiting·FFujian Medical University Union Hospital·Phase 2·NCT06601309·90 enrolled

Total Neoadjuvant Therapy1 trial

PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer

Not yet recruiting·SSun Yat-sen University·Phase 3·NCT07277842·382 enrolled

Treatment Failure1 trial

Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure

Unknown status·HHenan Cancer Hospital·Phase 2·NCT06334757·46 enrolled

SCLC1 trial

Serplulimab Combined With CCRT for LS-SCLC.

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT06295926·96 enrolled

Radiation Therapy1 trial

Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC

Recruiting·ZZhejiang Cancer Hospital·Phase 2·NCT06350162·100 enrolled

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

ES-SCLC1 trial

Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

Not yet recruiting·GGuangzhou Institute of Respiratory Disease·Phase 2·NCT06497530·30 enrolled

Adenocarcinoma1 trial

Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT05918419·35 enrolled

Necrosis1 trial

The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites

Recruiting·SSun Yat-sen University·Phase 2·NCT06433869·60 enrolled

Chemotherapy1 trial

Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC

Recruiting·SSichuan University·Phase 2·NCT05765825·61 enrolled

Metastatic Colorectal Cancer1 trial

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

Recruiting·FFudan University·Phase 2·NCT05954429·50 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

Recruiting·ZZekuan Xu·Phase 2·NCT06461910·30 enrolled

Advanced Solid Tumors With Neuroendocrine Differentiation1 trial

Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation

Not yet recruiting·RRenJi Hospital·Phase 2·NCT06531291·80 enrolled

Lung Cancer1 trial

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

Not yet recruiting·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1·NCT07231445·100 enrolled

Small Cell Lung Cancer1 trial

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

Not yet recruiting·—·Phase 1/2·NCT07141771·100 enrolled

Untreated Advanced NSCLC1 trial

A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients

Active, not recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT05787613·132 enrolled

Oligometastases1 trial

SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT06850103·51 enrolled

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

Ascites1 trial

PD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant Ascites

Unknown status·SSecond Affiliated Hospital of Soochow University·Phase 1/2·NCT05501340·40 enrolled

Esophageal Squamous Cell Carcinoma1 trial

Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

Recruiting·ZZhejiang Cancer Hospital·Phase 2·NCT06422858·37 enrolled

Triple-Negative Breast Cancer1 trial

Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer

Not yet recruiting·XXijing Hospital·Phase 2·NCT07466303·84 enrolled

Treatment1 trial

Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Not yet recruiting·PPeking University Shenzhen Hospital·Phase 2·NCT06692491·200 enrolled

Advanced/Metastatic Solid Tumors1 trial

A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 1/2·NCT06848699·105 enrolled

Advanced Solid Tumors1 trial

Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors

Recruiting·GGuangzhou FineImmune Biotechnology Co., LTD.·Phase 1·NCT06302062·23 enrolled

Advanced Malignant Solid Tumors1 trial

A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors

Recruiting·GGuangzhou FineImmune Biotechnology Co., LTD.·Phase 1·NCT06716619·32 enrolled

Locally Advanced Colorectal Cancer1 trial

A Single-Arm, Single-Center, Phase II Exploratory Clinical Study of Serplulimab Combined With Decitabine Plus CAPOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07691632·35 enrolled

Locally Advanced Gastric Cancer1 trial

A Prospective Exploratory Study of a HIPEC Priming Strategy Followed by Serplulimab Combined With SOX/XELOX as Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Not yet recruiting·SShanghai Changzheng Hospital·Phase 2·NCT07621484·48 enrolled

Sources

References

[1]
ClinicalTrials.gov — 63 trial records for Serplulimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Serplulimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Serplulimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Shanghai Henlius Biotech company filings. U.S. Securities and Exchange Commission.

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: Shanghai Henlius Biotech

Serplulimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Cervical Cancer6 trials

Non-Small Cell Lung Cancer5 trials

Gastric Cancer4 trials

Locally-advanced Rectal Cancer3 trials

Pancreatic Cancer2 trials

Breast Cancer2 trials

Gastric Adenocarcinoma2 trials

Neoadjuvant Therapy2 trials

Colorectal Cancer2 trials

Locally Advanced Colon Cancer2 trials

First-line Treatment1 trial

Neoadjuvant Treatment1 trial

Bevacizumab1 trial

Carboplatin1 trial

Nasopharyngeal Carcinoma1 trial

Safety and Efficacy1 trial

Locally Advanced1 trial

Total Neoadjuvant Therapy1 trial

Treatment Failure1 trial

SCLC1 trial

Radiation Therapy1 trial

Esophageal Cancer1 trial

ES-SCLC1 trial

Adenocarcinoma1 trial

Necrosis1 trial

Chemotherapy1 trial

Metastatic Colorectal Cancer1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Advanced Solid Tumors With Neuroendocrine Differentiation1 trial

Lung Cancer1 trial

Small Cell Lung Cancer1 trial

Untreated Advanced NSCLC1 trial

Oligometastases1 trial

Adjuvant Treatment1 trial

Ascites1 trial

Esophageal Squamous Cell Carcinoma1 trial

Triple-Negative Breast Cancer1 trial

Treatment1 trial

Advanced/Metastatic Solid Tumors1 trial

Advanced Solid Tumors1 trial

Advanced Malignant Solid Tumors1 trial

Locally Advanced Colorectal Cancer1 trial

Locally Advanced Gastric Cancer1 trial

References

Drug Info

Quick Facts

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