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Cadonilimab - Akeso Biopharma

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Drug Profile

Cadonilimab - Akeso Biopharma

Alternative Names: AK-104

Latest Information Update: 20 Jun 2025

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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 Liver cancer; Non-small cell lung cancer
  • Phase II Cholangiocarcinoma; Nasopharyngeal cancer; Ovarian cancer; Pancreatic cancer; Rectal cancer; Renal cell carcinoma; Solid tumours; Vulvovaginal cancer
  • Phase I/II Adenocarcinoma; Malignant melanoma; Peripheral T-cell lymphoma; Small cell lung cancer

Most Recent Events

  • 16 Jun 2025 Akeso Biopharma plans a phase-III trial for Adenocarcinoma (Combination therapy, Neoadjuvant, Adjuvant) in China (IV), (NCT07023315)
  • 31 May 2025 Registered for Cervical cancer (First-line therapy, Combination therapy, Late-stage disease, Recurrent, Metastatic disease) in China (IV)
  • 22 May 2025 Akeso plans a phase II trial for Liver cancer (Second-line therapy or greater, Late-stage disease, Combination therapy) (IV) (NCT06984718)

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