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Cadonilimab - Akeso Biopharma

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Drug Profile

Cadonilimab - Akeso Biopharma

Alternative Names: AK-104

Latest Information Update: 10 Mar 2026

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At a glance

  • Originator Akeso Biopharma
  • Developer Akeso Biopharma; Chipscreen Biosciences; Hunan Cancer Hospital; Sun Yat-Sen University; The Third Affiliated Hospital of Soochow University; University of Texas Southwestern Medical Center
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T-lymphocyte antigen 4 inhibitors; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Cervical cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cervical cancer
  • Registered Gastric cancer
  • Preregistration Oesophageal cancer
  • Phase III Adenocarcinoma; Liver cancer; Non-small cell lung cancer
  • Phase II Cholangiocarcinoma; Nasopharyngeal cancer; Ovarian cancer; Pancreatic cancer; Rectal cancer; Renal cell carcinoma; Solid tumours; Vulvar-neoplasms
  • Phase I/II Malignant melanoma; Peripheral T-cell lymphoma; Small cell lung cancer

Most Recent Events

  • 04 Mar 2026 Akeso plans a phase-III trial for Adenocarcinoma (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, First-line therapy) in China (SC, Injection; IV) in March 2026 (NCT07449780)
  • 17 Feb 2026 Akeso plans a phase-III trial for Adenocarcinoma (Late-stage disease) in China (Parenteral) in March 2026 (NCT07412613),
  • 19 Dec 2025 Phase-II clinical trials in Oesophageal cancer (Late-stage disease, Combination therapy) in China (IV) (NCT07263919)

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