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HLX 22

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Drug Profile

HLX 22

Alternative Names: AC-101; HLX-22

Latest Information Update: 22 Sep 2025

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At a glance

  • Originator Alligator Bioscience
  • Developer Shanghai Henlius Biotech
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Gastric cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Adenocarcinoma
  • Phase II Breast cancer; Gastric cancer; HER2 positive breast cancer
  • No development reported Solid tumours

Most Recent Events

  • 09 Sep 2025 Shanghai Zhongshan Hospital in collaboration with Shanghai Henlius Biotech plans a phase II trial for Adenocarcinoma (Metastatic disease, Combination therapy, First-Line therapy)(IV) in September 2025 (NCT07176702)
  • 02 Sep 2025 Regulatory authorities approve IND applications for HLX 22 for Gastric cancer in the EU prior to September 2025 (Shanghai Henlius Biotech pipeline, September 2025)
  • 14 Jul 2025 Regulatory authorities approve IND applications for HLX 22 for Gastric cancer in Chile, Brazil and Argentina

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