HLX43

Phase 3Small molecule

Shanghai Henlius Biotech

HLX43 is one of 391 small molecule programs targeting Neoadjuvant Therapy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

390

Competitors

Pipeline

Status by Indication[3][1]

Indication

Neoadjuvant TherapyRecruiting

Gastroesophageal Junction AdenocarcinomaRecruiting

Nasopharyngeal CarcinomaRecruiting

Triple-Negative Breast CancerNot yet recruiting

Non-Small Cell Lung CancerNot yet recruiting

Breast CancerNot yet recruiting

Colorectal CancerRecruiting

Pancreatic CancerNot yet recruiting

Head and Neck Squamous Cell CarcinomaRecruiting

Advanced/metastatic Solid TumorsRecruiting

Neoadjuvant TherapyPhase 2

Recruiting

Gastroesophageal Junction AdenocarcinomaPhase 2

Recruiting

Nasopharyngeal CarcinomaPhase 2

Recruiting

Triple-Negative Breast CancerPhase 2

Not yet recruiting

Non-Small Cell Lung CancerPhase 3

Not yet recruiting

Breast CancerPhase 2

Not yet recruiting

Colorectal CancerPhase 2

Recruiting

Pancreatic CancerPhase 2

Not yet recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Recruiting

Advanced/metastatic Solid TumorsPhase 2

Recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

HLX43

Shanghai Henlius Biotech

Phase 3

1 2

Adenocard

Astellas

Preclinical

2 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Spravato

WWim Janssens

Preclinical

2 9

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 10

Tricor

JJagotec

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Neoadjuvant Therapy

NCT07269782

Q2 2027

Phase 2Recruiting

Phase II Clinical Study

NCT06742892

Phase 2Recruiting

Phase II Clinical Study

NCT06769152

Phase 2Recruiting

Phase II Clinical Study

NCT06769113

Q3 2027

Phase 2Recruiting

Colorectal Cancer

NCT07106892

Q4 2027

Phase 1/2Recruiting

Advanced/metastatic Solid Tumors

NCT06848699

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2/3·NCT07459751·671 enrolled

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT06907615·243 enrolled

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Humanized Anti-PD-1 Monoclonal Antibody Injection) in Advanced Stage Lung Cancer

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT07253142·120 enrolled

Phase II Clinical Study3 trials

A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT06742892·90 enrolled

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT06769152·130 enrolled

A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT06769113·72 enrolled

Advanced/Metastatic Solid Tumors2 trials

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

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

Colorectal Cancer1 trial

Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT07106892·60 enrolled

Breast Cancer1 trial

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT07459738·60 enrolled

7 more indications

Triple-Negative Breast Cancer1 trial

Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT07487519·180 enrolled

Metastatic Colorectal Cancer1 trial

A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 1/2·NCT07358585·126 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT07115485·60 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT06857279·167 enrolled

Neoadjuvant Therapy1 trial

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

Nasopharyngeal Carcinoma1 trial

A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy

Recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT06839066·70 enrolled

Pancreatic Cancer1 trial

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT07301229·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for HLX43. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HLX43 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HLX43. 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

HLX43

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

Phase II Clinical Study3 trials

Advanced/Metastatic Solid Tumors2 trials

Colorectal Cancer1 trial

Breast Cancer1 trial

Triple-Negative Breast Cancer1 trial

Metastatic Colorectal Cancer1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Neoadjuvant Therapy1 trial

Nasopharyngeal Carcinoma1 trial

Pancreatic Cancer1 trial

References

Drug Info

Quick Facts

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