Akeso Receives Breakthrough Therapy Designation for Ivonescimab in Advanced Biliary Tract Cancer
Friday, February 06, 2026
Akeso has received a fifth Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for ivonescimab, a bispecific antibody that targets PD-1 and VEGF.
Biliary tract cancer (BTC) is a group of rare and aggressive cancers that develop in the bile ducts or gallbladder. The bile ducts carry bile from the liver to the small intestine and are essential for digestion.
Ivonescimab is currently being studied in a randomised, controlled, multicentre Phase III trial (AK112-309/HARMONi-GI1). The study is comparing ivonescimab plus chemotherapy with durvalumab plus chemotherapy in previously untreated patients with advanced BTC. Patient enrolment has been completed, and the new BTD is expected to support faster clinical development and regulatory review in China.
The latest designation covers ivonescimab used in combination with chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC).
This marks the fifth time ivonescimab has been granted BTD status by the NMPA. Previous designations were awarded for lung cancer indications and triple-negative breast cancer, reflecting the therapy’s potential across several cancers with high unmet medical needs.
Earlier evidence from a Phase Ib/II study, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, showed encouraging outcomes for the combination therapy. The study reported high tumour response and disease control rates, along with promising progression-free and overall survival results.
These findings support the ongoing Phase III trial and highlight ivonescimab’s potential to improve first-line treatment outcomes for patients with advanced biliary tract cancer, where effective long-term treatment options remain limited.
Source: akesobio.com
