Drug Profile

Cadonilimab - Akeso Biopharma

Alternative Names: AK-104

Latest Information Update: 15 Dec 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

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

04 Dec 2025 Cadonilimab plans a phase II trial for Oesophageal cancer in China (Neoadjuvant therapy, Combination therapy) in December 2025 (NCT07263919)
19 Oct 2025 Updated efficacy data from the phase III COMPASSION-15 trial in Gastric cancer released by Akeso Biopharma
15 Sep 2025 Akeso completes enrolment in its phase II COMPASSION-36 trial for Liver cancer (Second line therapy and greater, late stage disease, Combination therapy) in China, USA and Europe (IV) (NCT06984718)

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