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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 Dec 2025

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At a glance

  • Originator Shanghai Henlius Biotech
  • Class Antibodies; Antineoplastics; Drug conjugates; Immunoconjugates; Immunotherapies; 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 Adenocarcinoma; Cervical cancer; Colorectal cancer; Liver cancer; Nasopharyngeal cancer; Non-small cell lung cancer; Squamous cell cancer
  • Phase I/II Solid tumours

Most Recent Events

  • 23 Dec 2025 9456998 - No updates
  • 08 Dec 2025 Shanghai Henlius Biotech plans a phase II trial for Non small cell lung cancer (Neoadjuvant therapy, Combination therapy, Late-stage disease) in China (IV) in January 2026 (NCT07269782)
  • 28 Nov 2025 Shanghai Henlius Biotech plans a phase II trial for Non-Small-Cell-Lung-Cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (IV) in January 2026 (NCT07253142)

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