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HLX 43

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Drug Profile

HLX 43

Alternative Names: Anti-PD-L1 ADC; HLX-43

Latest Information Update: 10 Aug 2026

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At a glance

  • Originator Shanghai Henlius Biotech
  • Class Antineoplastics; Drug conjugates; Immunoconjugates; Monoclonal antibodies
  • Mechanism of Action DNA topoisomerase I inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Thymic epithelial tumour
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II/III Non-small cell lung cancer
  • Phase II Adenocarcinoma; Cervical cancer; Colorectal cancer; Liver cancer; Nasopharyngeal cancer; Squamous cell cancer
  • Phase I/II Solid tumours

Most Recent Events

  • 31 Jul 2026 The National Medical Products Administration (NMPA) approves the clinical trial application for HLX 43 for Solid tumours (Combination-therapy, Late-stage disease, Metastatic disease)
  • 10 Jul 2026 NMPA approves CTA for HLX 43 for Solid tumours (Combination therapy, Late-stage disease, Metastatic disease)
  • 10 Jul 2026 Shanghai Henlius Biotech plans a phase I trial for Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) (Parenteral)

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