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Ligufalimab - Akeso Biopharma

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Drug Profile

Ligufalimab - Akeso Biopharma

Alternative Names: AK-117

Latest Information Update: 25 Jul 2025

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At a glance

  • Originator Akeso Biopharma
  • Developer Akeso Biopharma; University of Texas Southwestern Medical Center
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; CD47 antigen inhibitors; 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
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Adenocarcinoma; Squamous cell cancer
  • Phase II Cholangiocarcinoma; Colorectal cancer; Gastric cancer; Liver cancer; Myelodysplastic syndromes; Oesophageal cancer; Triple negative breast cancer
  • Phase I/II Acute myeloid leukaemia; Hodgkin's disease; Solid tumours
  • Phase I Lymphoma

Most Recent Events

  • 23 Jul 2025 Phase-III clinical trials in Adenocarcinoma (First-line therapy, Combination therapy, Metastatic disease, Inoperable/Unresectable) in China (IV) (NCT06953999)
  • 01 May 2025 Akeso plans a phase III trial for Adenocarcinoma (First line therapy, Metastatic disease, Inoperable/Unresectable, Combination therapy) in China (NCT06953999 )
  • 18 Feb 2025 Phase-II clinical trials in Cholangiocarcinoma (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy) in USA (IV) (NCT06789848)

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