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Dulpatatug - Shanghai Henlius Biotech

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Drug Profile

Dulpatatug - Shanghai Henlius Biotech

Alternative Names: AC-101; HLX-22

Latest Information Update: 19 Mar 2026

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

Most Recent Events

  • 28 Feb 2026 Phase-II/III clinical trials in HER2-positive-breast-cancer (Combination therapy, First-line therapy, Recurrent, Metastatic disease, Late-stage disease) in China (IV) (NCT07294508)
  • 28 Feb 2026 Shanghai Henlius Biotech completes enrollment in a phase-II clinical trials in HER2-positive-breast-cancer (Combination therapy, Second-line therapy or greater, Late-stage disease, Metastatic disease) in China (IV) (NCT06832202)
  • 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)

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