Shares of AKESO (09926) surged more than 9% during intraday trading before paring gains to trade 6.81% higher at HK$94.85, with turnover reaching HK$814 million. The sharp move followed the company's announcement of a major clinical breakthrough.

The biopharmaceutical firm revealed that its first-in-class PD-1/VEGF bispecific tumor immunotherapy drug, Evonex (Yidaifang®), combined with chemotherapy, achieved statistically significant and clinically meaningful positive results in a randomized, controlled, double-blind, multicenter Phase III study (AK112–309/HARMONi-GI1). The trial evaluated the regimen as a first-line treatment for advanced biliary tract cancer, comparing it against durvalumab (PD-L1) plus chemotherapy, and successfully met its primary endpoint of overall survival (OS).

According to the announcement, the study also hit all key secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR), with balanced baseline characteristics among participants. This marks the first Phase III trial in biliary tract cancer to demonstrate a significant OS benefit using the global gold standard (PD-L1 monoclonal antibody plus chemotherapy) as the active comparator, representing a major milestone in the treatment of this disease.

This achievement underscores that Evonex has now secured positive Phase III results in four indications within lung cancer and has now extended its success to other solid tumors, reinforcing its potential as a transformative therapy across multiple cancer types.