Akeso Inc. Receives Approval from NMPA and FDA to Initiate Global Registrational Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma

Reuters
08/04
Akeso Inc. Receives Approval from NMPA and FDA to Initiate Global Registrational Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma

Akeso Inc., a biotechnology company, has announced the approval to initiate a global, multicenter, randomized Phase II registrational trial for their PD-1/CTLA-4 bispecific antibody, cadonilimab. The trial, known as COMPASSION-36/AK104-225, has received regulatory clearance from both China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). This trial will evaluate the efficacy of cadonilimab in combination with lenvatinib versus lenvatinib alone in treating advanced hepatocellular carcinoma $(HCC)$ in patients who have previously been treated with atezolizumab and bevacizumab. This approval marks a significant step for Akeso in addressing the global challenge of cancer immunotherapy resistance and advancing treatment options for patients with limited survival benefits from current therapies.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Akeso Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN43333) on August 04, 2025, and is solely responsible for the information contained therein.

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