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Cadonilimab - Akeso Biopharma

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Drug Profile

Cadonilimab - Akeso Biopharma

Alternative Names: AK-104

Latest Information Update: 28 Jul 2026

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At a glance

  • Originator Akeso Biopharma
  • Developer Akeso Biopharma; Chipscreen Biosciences; Hunan Cancer Hospital; Sun Yat-Sen 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 Adenocarcinoma; Cervical cancer
  • Phase III Colorectal cancer; Liver cancer; Non-small cell lung cancer
  • Phase II Cholangiocarcinoma; Nasopharyngeal cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Rectal cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer; Vulvar-neoplasms
  • Phase I/II Malignant melanoma; Peripheral T-cell lymphoma; Small cell lung cancer

Most Recent Events

  • 28 Jul 2026 No recent reports of development identified for phase-I development in Solid-tumours(Combination therapy, Late-stage disease) in China (IV)
  • 14 Jul 2026 Akeso plans a phase III trial for Adenocarcinoma (Combination therapy, First-line therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA, China, Germany, Poland (Parenteral) in August 2026 (NCT07700979)
  • 26 Jun 2026 Launched for Adenocarcinoma (Metastatic disease, Late-stage disease, Inoperable/Unresectable, First-line therapy, Combination therapy) in China (IV)

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