Drug intelligence / Profile preview

HLX43

Development stage
Phase 3
Lead developer
Henlius
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

HLX43 is a novel antibody-drug conjugate (ADC) targeting programmed death-ligand 1 (PD-L1), developed by Shanghai Henlius Biotech in collaboration with MediLink Therapeutics. The drug consists of a high-affinity humanized IgG1 monoclonal antibody against PD-L1, conjugated via cleavable linkers to a novel DNA topoisomerase I inhibitor payload. This design enables selective delivery and release of the cytotoxic agent within the tumor microenvironment, resulting in double-strand DNA breaks and apoptosis of cancer cells. Preclinical studies have demonstrated robust bystander effects and potent anti-tumor activity with minimal immunotoxicity against PD-L1-positive human antigen-presenting cells. HLX43 is being investigated for multiple advanced or metastatic solid tumors, including esophageal squamous cell carcinoma (ESCC), non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), nasopharyngeal carcinoma, uterine cervical cancer, and others.

Other names
anti-PD-L1 ADCanti-PD-L-1 ADCanti-PD-L 1 ADC
02

Targets

CD274 (Programmed cell death protein 1 ligand 1)TOP1 (DNA Topoisomerase I)

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