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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: 23 Aug 2025

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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.

    No
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 23 Aug 2025 9448363- Added clinical data, approval info in KDM and HE, Added planned trial info in KDM and HE
  • 19 Aug 2025 Shanghai Henlius Biotech plans a phase II trial for Adenocarcinoma (Late-stage disease, Metastatic disease) in China (IV), in August 2025 (NCT07115485)
  • 07 Aug 2025 US FDA approves IND application for HLX43 (Injection) in Malignant-thymoma

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