AKESO (09926) surged over 3% again, reaching HK$121.9 by the time of writing, with a trading volume of HK$271 million. The company announced via its official WeChat account that the U.S. Food and Drug Administration (FDA) has approved its global Phase III multicenter clinical trial (COMPASSION-37/AK104-311) for cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody. The trial will evaluate cadonilimab combined with chemotherapy versus chemotherapy with or without nivolumab as a first-line treatment for HER2-negative unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma.
COMPASSION-37 marks the second international multicenter registrational study for cadonilimab. Previously, a global registrational trial for cadonilimab in immunotherapy-resistant hepatocellular carcinoma had already commenced in the U.S. The approval of COMPASSION-37 represents a critical milestone in AKESO's global development strategy for cadonilimab and reinforces the company's leading position in the field of immuno-oncology 2.0.
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