AKESO (09926): The AK112309/HARMONi-GI1 Phase III clinical trial achieved statistically significant positive results in overall survival (OS) when comparing the efficacy of Abraxane combined with gemcitabine to that of Atezolizumab combined with chemotherapy, indicating substantial clinical benefits.

AKESO (09926) announced that based on the pre-specified interim analysis results evaluated by the Independent Data Monitoring Committee (IDMC), the globally pioneering dual-specificity antibody IdecabTAG (Ivorasi, PD-1/VEGF) combined with chemotherapy showed positive results in a randomized, controlled, double-blind, multi-center Phase III clinical study (AK112309/HARMONi-GI1) comparing it to Durvalumab (PD-L1) combined with chemotherapy for first-line treatment of advanced biliary tract cancer. The study achieved the primary endpoint of overall survival (OS) with statistically significant and clinically meaningful benefits; it also met all key secondary endpoints for progression-free survival (PFS) and objective response rate (ORR). Detailed data from this study will be published at upcoming international academic conferences and in academic journals. The positive results from the HARMONi-GI1 study mark the first Phase III study in the field of gastrointestinal tumors to show positive results for Ivorasi, following four positive results in Phase III studies for lung cancer. The breakthrough clinical value of Ivorasi is thus expanding from lung cancer to a broader range of solid tumors. HARMONi-GI1/AK112309 (CTR20243164) is a randomized, controlled, multi-center Phase III clinical study assessing the efficacy of Ivorasi combined with chemotherapy versus Durvalumab combined with chemotherapy for first-line treatment of advanced biliary tract cancer. The primary endpoint of the study is overall survival (OS), while the key secondary endpoints include progression-free survival (PFS) and objective response rate (ORR) as assessed by investigators based on the RECIST version 1.1 criteria. A total of 682 participants were enrolled in the HARMONi-GI1 study. IdecabTAG (Ivorasi, PD-1/VEGF) is a globally pioneering PD-1/VEGF dual-specificity tumor immunotherapy drug independently developed by the company. Ivorasi received approval from the NMPA for market launch on May 24, 2024, for the treatment of locally advanced or metastatic non-squamous NSCLC with EGFR mutations that progressed after EGFR-TKI treatment; it gained approval for a new indication on April 25, 2025, for first-line treatment of PD-L1 positive locally advanced or metastatic NSCLC. These two indications have been included in the latest National Medical Insurance Directory. Ivorasi was approved for a new indication on August 12, 2026, for first-line treatment of squamous NSCLC. Ivorasi has initiated 60 Phase II/III clinical studies targeting over 40 indications, including lung cancer, biliary tract cancer, head and neck squamous carcinoma, triple-negative breast cancer, colorectal cancer, pancreatic cancer, and urothelial carcinoma. Currently, a total of 16 registrational Phase II/III clinical studies are progressing efficiently.