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 42 indications, with its most advanced program in Phase 3.[1]

Serplulimab is one of 690 small molecule programs targeting Cervical Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

689

Competitors

Pipeline

Status by Indication[3][1]

Indication

Cervical CancerRecruiting

Locally Advanced Colon CancerUnknown status

Locally Advanced Gastric CancerNot yet recruiting

Neurofibromatosis Type 2Not yet recruiting

Locally Advanced Colorectal CancerNot yet recruiting

NF2-Related SchwannomatosisNot yet recruiting

TreatmentNot yet recruiting

HR+/HER2- Breast CancerRecruiting

Pancreatic Ductal AdenocarcinomaNot yet recruiting

Locally-Advanced Rectal CancerRecruiting

Cervical CancerPhase 3

Recruiting

Locally Advanced Colon CancerPhase 2

Unknown status

Locally Advanced Gastric CancerPhase 2

Not yet recruiting

Neurofibromatosis Type 2Phase 2

Not yet recruiting

Locally Advanced Colorectal CancerPhase 2

Not yet recruiting

NF2-Related SchwannomatosisPreclinical

Not yet recruiting

TreatmentPhase 2

Not yet recruiting

HR+/HER2- Breast CancerPhase 2

Recruiting

Pancreatic Ductal AdenocarcinomaPreclinical

Not yet recruiting

Locally-Advanced Rectal CancerPhase 2

Recruiting

Showing 10 of 42 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Serplulimab

Shanghai Henlius Biotech

Phase 3

5 2

Albumin Paclitaxel

CChipscreen Biosciences, Ltd.

Phase 3

3 3

SYS6010

CCSPC Megalith Biopharmaceutical Co.,Ltd.

Phase 3

2 4

Pemetrexed/carboplatin

AstraZeneca

Phase 3

6 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

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

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

Serplulimab for Locally Advanced Cervical Cancer

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

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 Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer

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

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

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

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

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

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

Show 1 more trial

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

Locally-advanced Rectal Cancer3 trials

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

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

Locally Advanced Colon Cancer2 trials

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

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

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

42 more indications

Colorectal Cancer2 trials

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

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

Neoadjuvant Therapy2 trials

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

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

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

Evaluation of Safety and Efficacy of Serplulimab Plus Chemotherapy in Patients With Histological Transformation From EGFR-mutated NSCLC to SCLC After Treatment: a Single-arm, Multicenter, Open-label Phase II Study

Active, not recruiting·GGuangdong Association of Clinical Trials·Phase 2·NCT05957510·66 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

Recruiting·NNational Cancer Center, Japan·Phase 2·NCT07699939·136 enrolled

Locally Advanced Colorectal Cancer2 trials

A Single-Arm, Phase II, Multicenter Study of Serplulimab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

Not yet recruiting·XXijing Hospital·Phase 2·NCT07819604·85 enrolled

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

Pancreatic Cancer1 trial

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

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

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

Locally Advanced1 trial

Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC

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

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

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

SCLC1 trial

Serplulimab Combined With CCRT for LS-SCLC.

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

Carboplatin1 trial

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

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

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

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

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

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

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

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

Recruiting·SSichuan University·Phase 2·NCT05765825·61 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

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

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

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

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

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

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

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

Breast Cancer1 trial

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

Recruiting·HHenan Cancer Hospital··NCT06781281·709 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

A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of YL201 in Combination With Serplulimab Versus Carboplatin and Etoposide in Combination With Serplulimab as First-line Treatment in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer

Recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 3·NCT07739758·442 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

A Phase Ib/II Clinical Trial of JDB153 Combined With Serplulimab for the Treatment of Pancreatic Cancer Refractory to Standard Therapy

Not yet recruiting·WWest China Hospital·Preclinical·NCT07175389·10 enrolled

HR+/HER2- Breast Cancer1 trial

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

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

Neurofibromatosis Type 21 trial

Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2)

Not yet recruiting·BBeijing Tiantan Hospital·Phase 2·NCT07713745·200 enrolled

NF2-related schwannomatosis1 trial

A Multicenter, Open-Label Study of Luvometinib in Combination With Serplulimab for the Treatment of NF2-Related Tumors

Not yet recruiting·BBeijing Tiantan Hospital·Preclinical·NCT07708285·30 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 — 67 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

Locally Advanced Colon Cancer2 trials

Colorectal Cancer2 trials

Neoadjuvant Therapy2 trials

Small Cell Lung Cancer2 trials

Gastric Adenocarcinoma2 trials

Locally Advanced Colorectal Cancer2 trials

Pancreatic Cancer1 trial

Esophageal Cancer1 trial

Total Neoadjuvant Therapy1 trial

Locally Advanced1 trial

Adenocarcinoma1 trial

Untreated Advanced NSCLC1 trial

Necrosis1 trial

SCLC1 trial

Carboplatin1 trial

Advanced Solid Tumors With Neuroendocrine Differentiation1 trial

Adjuvant Treatment1 trial

Esophageal Squamous Cell Carcinoma1 trial

Metastatic Colorectal Cancer1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Radiation Therapy1 trial

Triple-Negative Breast Cancer1 trial

Treatment1 trial

First-line Treatment1 trial

Neoadjuvant Treatment1 trial

Oligometastases1 trial

Chemotherapy1 trial

Ascites1 trial

Advanced/Metastatic Solid Tumors1 trial

Treatment Failure1 trial

Advanced Malignant Solid Tumors1 trial

Advanced Solid Tumors1 trial

Lung Cancer1 trial

ES-SCLC1 trial

Bevacizumab1 trial

Breast Cancer1 trial

Locally Advanced Nasopharyngeal Carcinoma1 trial

SCLC, Extensive Stage1 trial

Pancreatic Ductal Adenocarcinoma1 trial

HR+/HER2- Breast Cancer1 trial

Neurofibromatosis Type 21 trial

NF2-related schwannomatosis1 trial

Locally Advanced Gastric Cancer1 trial

References

Drug Info

Quick Facts

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