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HLX 22

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Drug Profile

HLX 22

Alternative Names: AC-101; HLX-22

Latest Information Update: 28 Feb 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 28 Feb 2025 No recent reports of development identified for phase-I development in Solid-tumours(Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (IV, Injection)
  • 26 Feb 2025 Shanghai Henlius Biotech plans a phase II trial in Breast cancer (Late-stage disease, Metastatic disease, Combination therapy) in China (Parenteral, Injection) (NCT06832202)
  • 07 Feb 2025 NMPA approves IND application for HLX 22 in Adenocarcinoma of the gastric and/or gastroesophageal junction

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