Akeso, a biopharmaceutical company focused on developing innovative biological medicines, announced that China's National Medical Products Administration (NMPA) has granted Priority Review to ivonescimab in combination with chemotherapy for the first-line treatment of locally advanced or metastatic Biliary Tract Cancer (BTC). The designation is expected to accelerate the regulatory review process for the indication in China.

The regulatory development follows positive results from the Phase 3 HARMONi-GI1 study (AK112-309), a randomised, double-blind, multicentre registrational trial evaluating ivonescimab combined with chemotherapy against durvalumab plus chemotherapy in patients with BTC. The combination demonstrated superior survival outcomes compared with the control regimen.

In a prespecified interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), the study met its primary endpoint of Overall Survival (OS), demonstrating a statistically significant and clinically meaningful improvement in the ivonescimab combination arm. The trial also achieved its key secondary endpoints, including Progression-Free Survival (PFS) and Objective Response Rate (ORR).

The HARMONi-GI1 findings were presented as a late-breaking abstract during an oral presentation at the European Society for Medical Oncology (ESMO) Presidential Symposium in October 2026. According to Akeso, the study is the first Phase 3 trial in BTC to demonstrate a statistically significant overall survival benefit against the established first-line standard of a PD-L1 inhibitor combined with chemotherapy.

On October 21, 2026, Summit Therapeutics announced a clinical trial collaboration with the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) to evaluate ivonescimab combined with chemotherapy against pembrolizumab- or durvalumab-based chemotherapy regimens. The registration-enabling Phase 2/3 study, EA2251, will assess the safety and efficacy of these combinations in patients receiving first-line treatment for advanced BTC.

Ivonescimab is a PD-1/VEGF bispecific antibody independently developed by Akeso. It combines immuno-oncology and anti-angiogenesis mechanisms within a single molecule and is designed to target both tumour immune evasion and tumour-associated blood vessel formation. The therapy is the first approved bispecific antibody combining these two mechanisms. It has also demonstrated positive results in a Phase 3 head-to-head study against pembrolizumab.

Akeso is advancing a global clinical development programme for ivonescimab across multiple cancer types and treatment settings. More than 17 Phase 3 studies are underway globally, including seven international multi-regional registrational trials and seven head-to-head studies against PD-1/PD-L1 therapies.

The development programme includes eight registrational or Phase 3 studies in lung cancer, along with clinical trials in first-line Microsatellite-Stable/proficient Mismatch Repair (MSS/pMMR) colorectal cancer, PD-L1-positive head and neck squamous cell carcinoma, triple-negative breast cancer, pancreatic cancer, urothelial carcinoma and biliary tract cancer.

The company is also advancing ivonescimab as part of its broader IO2.0 and ADC2.0 development strategy, with the objective of developing new treatment options across major cancer indications.

Akeso has licensed the exclusive rights to develop and commercialise ivonescimab in the United States, Canada, South America, Europe, the Middle East, Africa and Japan to Summit Therapeutics. The agreement carries a total potential value of up to USD 5 billion.