HLX10

Phase 3Small molecule

Shanghai Henlius Biotech

HLX10 is one of 220 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

219

Competitors

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Breast CancerActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Gastric CancerActive, not recruiting

Cervical CancerActive, not recruiting

Small Cell Lung CancerActive, not recruiting

Esophageal Squamous Cell CarcinomaPhase 3

Active, not recruiting

Metastatic Colorectal CancerPhase 2/Phase 3

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Hepatocellular CarcinomaPhase 2

Active, not recruiting

Gastric CancerPhase 3

Active, not recruiting

Cervical CancerPhase 3

Active, not recruiting

Small Cell Lung CancerPhase 2

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

HLX10

Shanghai Henlius Biotech

Phase 3

1 2

Tecentriq

Roche

Preclinical

36 3

Trodelvy

Gilead

Preclinical

37 4

Halaven

Eisai

Preclinical

38 5

Tykerb

GSK

Preclinical

80 6

Adriamycin

GGynecologic Oncology Group

Preclinical

87 7

Avastin

BBio-Thera Solutions

Preclinical

153 8

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Recurrent or Metastatic NPC

NCT05513573

Q4 2026

Phase 2Not yet recruiting

Phase II Clinical Study

NCT05239650

Phase 2/3Recruiting

Metastatic Colorectal Cancer

NCT04547166

Q1 2027

Phase 2Recruiting

Hepatocellular Carcinoma

NCT06349980

Q2 2027

Phase 3Not yet recruiting

Breast Cancer

NCT04301739

Phase 2Recruiting

Efficacy and Safety

NCT07457528

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma3 trials

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT06349980·117 enrolled

HLX07 Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT05290220·60 enrolled

A Clinical Study Evaluating the Use of HLX10 in Combination With HLX04 for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT03973112·123 enrolled

Small Cell Lung Cancer2 trials

A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

Active, not recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 3·NCT05353257·511 enrolled

A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT05354700·20 enrolled

First-line Treatment2 trials

A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC

Withdrawn· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 3·NCT04465734

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 3·NCT04033354·537 enrolled

Efficacy and Safety2 trials

A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC

Completed· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 3·NCT04063163·585 enrolled

Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07457528·46 enrolled

Patients With Advanced Solid Tumors2 trials

A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Anti-PD-1 Antibody (HLX10) in Combination With Avastin Biosimilar (HLX04) in Patients With Advanced Solid Tumors

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 1·NCT03757936·30 enrolled

Phase 1 Study of HLX10, a Monoclonal Antibody Targeting Programmed Death-1 (PD-1) in Patients With Advanced Solid Tumors

Unknown status·HHenlix, Inc·Phase 1·NCT03468751·30 enrolled

16 more indications

Recurrent or Metastatic NPC1 trial

Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC

Active, not recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT05513573·75 enrolled

Esophageal Squamous Cell Carcinoma1 trial

A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 3·NCT03958890·489 enrolled

Breast Cancer1 trial

to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 3·NCT04301739·522 enrolled

Concurrent Chemoradiotherapy1 trial

Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

Recruiting·—·Phase 2·NCT05443646·55 enrolled

Advanced or Metastatic Solid Tumors1 trial

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 in Combination With HLX10 in Patients With Advanced or Metastatic Solid Tumors

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 1·NCT05442996·30 enrolled

Phase II Clinical Study1 trial

Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT05239650·50 enrolled

Head and Neck Tumors1 trial

Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT04297995·131 enrolled

Locally-advanced Rectal Cancer1 trial

A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in High-Risk Locally Advanced Rectal Cancer

Not yet recruiting·TTao Zhang·Phase 3·NCT07113275·435 enrolled

Metastatic Solid Tumor1 trial

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor

Completed· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 1·NCT05400265·9 enrolled

Solid Tumors1 trial

A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT03941574·108 enrolled

Gastric Cancer1 trial

A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 3·NCT04139135·642 enrolled

Efficacy1 trial

Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC

Terminated· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT05584137·2 enrolled

Metastatic Colorectal Cancer1 trial

A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2/3·NCT04547166·568 enrolled

Cervical Cancer1 trial

A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer

Withdrawn· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 3·NCT04806945

Advanced/Metastatic Solid Tumors1 trial

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 1·NCT06115642·340 enrolled

Combination Therapy1 trial

Combination Therapy of HAIC and HLX10 and HLX04 in HCC With Major Portal Vein Tumor Thrombosis

Unknown status·SShanghai Zhongshan Hospital·Phase 2·NCT04947826·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for HLX10. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HLX10 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HLX10. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Shanghai Henlius Biotech company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Shanghai Henlius Biotech

HLX10

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Hepatocellular Carcinoma3 trials

Small Cell Lung Cancer2 trials

First-line Treatment2 trials

Efficacy and Safety2 trials

Patients With Advanced Solid Tumors2 trials

Recurrent or Metastatic NPC1 trial

Esophageal Squamous Cell Carcinoma1 trial

Breast Cancer1 trial

Concurrent Chemoradiotherapy1 trial

Advanced or Metastatic Solid Tumors1 trial

Phase II Clinical Study1 trial

Head and Neck Tumors1 trial

Locally-advanced Rectal Cancer1 trial

Metastatic Solid Tumor1 trial

Solid Tumors1 trial

Gastric Cancer1 trial

Efficacy1 trial

Metastatic Colorectal Cancer1 trial

Cervical Cancer1 trial

Advanced/Metastatic Solid Tumors1 trial

Combination Therapy1 trial

References

Drug Info

Quick Facts

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