AKESO (09926) has announced that its independently developed, first-in-class bispecific antibody, 依达方® (ivonescimab, PD-1/VEGF), combined with chemotherapy, demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to durvalumab (PD-L1) plus chemotherapy as a first-line treatment for advanced biliary tract cancer.

The positive results come from a pre-specified interim analysis of the randomized, controlled, double-blind, multicenter Phase III study (AK112–309/HARMONi-GI1), evaluated by an Independent Data Monitoring Committee (IDMC). The trial met its primary endpoint of OS, and also achieved all key secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR). Detailed data from this study will be presented at future international academic conferences and published in peer-reviewed journals.

The success of the HARMONi-GI1 study marks a significant milestone for ivonescimab, as it is the first positive Phase III result in gastrointestinal tumors following four prior positive Phase III trials in lung cancer. This demonstrates the drug's expanding clinical value, extending its breakthrough potential from lung cancer to a broader range of solid tumors.

HARMONi-GI1/AK112–309 (CTR20243164) is a randomized, controlled, multicenter Phase III study evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer. The primary endpoint is OS, with key secondary endpoints of PFS and ORR assessed by investigators using RECIST version 1.1. A total of 682 patients were enrolled in the study.

依达方® (ivonescimab, PD-1/VEGF) is a first-in-class PD-1/VEGF bispecific tumor immunotherapy drug independently developed by AKESO. It received NMPA approval for marketing on May 24, 2024, for the treatment of EGFR-mutated locally advanced or metastatic non-squamous NSCLC that has progressed after EGFR-TKI therapy. On April 25, 2025, a new indication was approved for first-line treatment of PD-L1-positive locally advanced or metastatic NSCLC. Both indications have been included in the latest version of the National Reimbursement Drug List. On August 12, 2026, 依达方® received approval for a new indication for first-line treatment of squamous NSCLC.

Ivonescimab is currently being studied across more than 40 indications, including lung cancer, biliary tract cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, colorectal cancer, pancreatic cancer, and urothelial carcinoma, with 60 Phase II/III clinical studies underway. At present, a total of 16 registrational Phase II/III clinical studies are being efficiently advanced.