HLX26

Phase 2Small molecule

Shanghai Henlius Biotech

HLX26 is one of 4 small molecule programs targeting Untreated Advanced NSCLC. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Untreated Advanced NSCLCActive, not recruiting

Untreated Advanced NSCLCPhase 2

Active, not recruiting

Competition

Competitive Landscape

3 competitors in Untreated Advanced NSCLC

#DrugCompanyPhaseTrials

Zegfrovy

DDizal Pharmaceuticals

Phase 2

1 2

Chemotherapy Drug

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Phase 2

1 3

Serplulimab

Shanghai Henlius Biotech

Phase 2

1 4

HLX26

Shanghai Henlius Biotech

Phase 2

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

Timeline

Expected Milestones

Q3 2027

Phase 2Active, not recruiting

Untreated Advanced NSCLC

NCT05787613

Clinical

Trials by Indication[1]

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 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

Lymphoma1 trial

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Solid Tumor or Lymphoma

Completed· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 1·NCT05078593·18 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

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for HLX26. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HLX26 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HLX26. 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 2[1]
Company: Shanghai Henlius Biotech

HLX26

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Trials by Indication[1]

Efficacy1 trial

Metastatic Solid Tumor1 trial

Lymphoma1 trial

Untreated Advanced NSCLC1 trial

References

Drug Info

Quick Facts

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