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HLX 22

Drug Profile

HLX 22

Alternative Names: AC-101; HLX-22

Latest Information Update: 24 Dec 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 Dec 2025 Shanghai Henlius Biotech plans a phase II/III trial for HER2 positive breast cancer (Combination therapy, Neoadjuvant therapy, Late-stage disease, First-line therapy) (Injection) in January 2026 (NCT07294534)
  • 09 Dec 2025 Shanghai Henlius Biotech plans a phase II/III trial for HER2-positive-breast-cancer (Combination therapy, First-line therapy, Recurrent, Metastatic disease, Late-stage disease) in January 2026 (NCT07294508)
  • 09 Dec 2025 NMPA approves IND applications for HLX 22 in combination with HLX 87 in HER 2 positive breast cancer

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