Akeso Biopharma (HKG: 9926) announced that the U.S. FDA approved cadonilimab in combination with chemotherapy to initiate the international multicenter Phase 3 COMPASSION‑37/AK104‑311 study. The trial will compare cadonilimab plus chemotherapy against chemotherapy with or without nivolumab for first‑line treatment of HER2‑negative unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. This marks the second international registration study for cadonilimab.
First‑line persistent/recurrent/metastatic cervical cancer ± bevacizumab
Strategic Implications
For Akeso: International validation of cadonilimab’s platform; second global registration study positions drug for potential US/EU submissions; builds on China leadership in bispecific antibodies.
For Gastric Cancer Market: First‑line HER2‑negative G/GEJ represents 90,000+ eligible patients annually in US/EU; cadonilimab’s PD‑1/CTLA‑4 mechanism could differentiate from nivolumab monotherapy.
For Investors: Demonstrates Akeso’s capability to execute global Phase 3 trials, supporting premium valuation of bispecific pipeline; potential for partnering/licensing in ex‑China markets.
Forward‑Looking Statements This brief contains forward‑looking statements regarding COMPASSION‑37 enrollment timelines, regulatory approvals, and market opportunities. Actual results may differ due to competitive dynamics, regulatory feedback, or clinical risks.-Fineline Info & Tech
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