Biotechnology
Akeso’s Ivonescimab Wins China Priority Review in Biliary Cancer
Add Securities.io to your preferred sources on Google
Akeso announced on November 4, 2026 that China’s National Medical Products Administration had granted Priority Review to ivonescimab plus chemotherapy for first-line treatment of locally advanced or metastatic biliary tract cancer. The designation is expected to accelerate the subsequent regulatory review in China; it does not constitute marketing approval.
The regulatory status has moved beyond the October 25, 2026 results disclosure, which described Priority Review as proposed. The supporting study is HARMONi-GI1, also called AK112-309, a randomized, controlled, double-blind, multicenter registrational Phase III trial. It compared ivonescimab plus chemotherapy with durvalumab plus chemotherapy, the current global first-line standard. In a prespecified interim analysis reviewed by an Independent Data Monitoring Committee, the trial met its primary overall-survival endpoint and key secondary endpoints including progression-free survival and objective response rate.
Ivonescimab is a PD-1/VEGF bispecific antibody that combines immuno-oncology and anti-angiogenesis mechanisms in one molecule. The disease context underscores the therapeutic challenge: Akeso’s disease overview says approximately half of biliary tract cancer patients are diagnosed at an advanced stage and that survival is typically less than one year.
Survival Data Behind the Review
In the intent-to-treat population, Akeso reported median overall survival of 14.9 months with ivonescimab plus chemotherapy, versus 12.1 months with durvalumab plus chemotherapy. The hazard ratio was 0.75, with a 95% confidence interval of 0.61–0.92 and P=0.0031. Eighteen-month overall-survival rates were 44.0% and 32.5%, respectively, indicating that the separation between the arms persisted beyond the median.
The secondary measures pointed in the same direction. Median progression-free survival was 8.4 months with ivonescimab versus 5.8 months with durvalumab, with a hazard ratio of 0.61 and P<0.0001. Objective response rates were 53.8% and 32.5%, respectively. The detailed findings were presented on October 25, 2026 as a Late-Breaking Abstract during an ESMO Presidential Symposium in Madrid.
Akeso characterized the combination’s safety profile as manageable and reported no new safety signals. The most common any-grade and grade 3/4 adverse events were hematologic toxicities. Serious adverse events occurred in 43.4% of the ivonescimab arm and 43.7% of the durvalumab arm. Any-grade bleeding occurred in 9.7% versus 6.5%, while grade 3-or-higher bleeding occurred in 1.5% versus 1.8%, respectively.
International Development and Commercial Rights
An October 21, 2026 collaboration announcement said Summit Therapeutics (SMMT ) had entered a clinical-trial collaboration with ECOG-ACRIN Cancer Research Group for EA2251, a registration-enabling Phase II/III study. EA2251, identifier NCT07765433, is designed to compare ivonescimab plus chemotherapy with pembrolizumab or durvalumab plus chemotherapy in first-line advanced biliary tract cancer. It is the second Phase III registrational study of ivonescimab in this cancer and the seventh international registrational Phase II/III trial for the drug. United States site activations were expected to begin in the fourth quarter of 2026.
Akeso has licensed Summit exclusive development and commercialization rights in the United States and Canada, South America, Europe, the Middle East, Africa, and Japan under an agreement with total potential value of up to US$5 billion. Akeso currently reports more than 17 Phase III studies of ivonescimab underway globally, including seven international multi-regional registrational Phase III trials and seven head-to-head studies against PD-1 or PD-L1 therapies.
Priority Review therefore advances the Chinese regulatory process without settling the approval decision. Chinese regulators will assess the existing HARMONi-GI1 evidence, while a central open question for the wider program is whether EA2251 will reproduce the survival benefit seen against durvalumab in a separate international registration-enabling study.
