Akeso's Ivonescimab Wins China Priority Review in Biliary Cancer
HONG KONG – – November 05, 2026 -- China's National Medical Products Administration (NMPA) has granted Priority Review to Akeso's ivonescimab plus chemotherapy for first-line locally advanced or metastatic biliary tract cancer (BTC), a designation expected to accelerate the subsequent regulatory review in China.
HARMONi-GI1 Phase III trial beats durvalumab regimen on overall survival
In the randomized, double-blind, multicenter HARMONi-GI1 study (AK112-309), ivonescimab plus chemotherapy was compared with durvalumab plus chemotherapy, the current global first-line standard in BTC. A prespecified interim analysis reviewed by the Independent Data Monitoring Committee showed the trial met its primary endpoint of overall survival (OS). The improvement over the control arm was statistically significant and clinically meaningful. The study also met all key secondary endpoints, including progression-free survival and objective response rate.