NMPA grants priority review for Akeso cancer therapy

China’s National Medical Products Administration (NMPA) has granted priority review to Akeso’s ivonescimab when used in combination with chemotherapy for patients with locally advanced or metastatic biliary tract cancer. The designation is expected to accelerate the regulatory assessment process in the region.

The regulatory filing follows the Phase III HARMONi-GI1 trial, which evaluated the therapy against the current standard of care—durvalumab combined with chemotherapy. Results indicated that the ivonescimab combination met its primary endpoint of overall survival, demonstrating statistically significant benefits over the control arm.

The study data were presented at the ESMO Presidential Symposium in October 2026. Ivonescimab, a bispecific antibody targeting both PD-1 and VEGF, remains a key component of Akeso's clinical pipeline. The company has out-licensed development and commercialization rights for the drug in major markets outside China to Summit Therapeutics in a deal valued at up to $5 billion.