ALPHAMAB-B (09966): Latest results from two Phase III clinical studies of anbenitamab (KN026) presented as late-breaking abstract oral presentations at the 2026 ESMO Congress

ALPHAMAB-B (09966) announced that the significant results of anbenitamab (trade name: Ennitamab, development code: KN026) in the first-line treatment of HER2+ BC and the updated OS analysis for second-line and above treatment of HER2+ GC/GEJ, jointly developed with CSPC PHARMA's subsidiary Jinmante Biotech, were presented as late-breaking abstract oral presentations at the 2026 ESMO Congress. KN026-003/Healer is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of anbenitamab in combination with docetaxel for injection (albumin-bound) (HB1801) versus trastuzumab plus pertuzumab and docetaxel (THP regimen) in the first-line treatment of HER2+ recurrent or metastatic BC, with the primary endpoint being PFS assessed by BIRC. Patients with HER2+ advanced BC (who had not previously received chemotherapy or HER2-targeted therapy in the advanced setting) were randomized in a 1:1 ratio to receive either anbenitamab in combination with HB1801 (anbenitamab group) or the THP regimen (THP group). In June 2026, the study successfully met the primary endpoint as assessed by the independent data monitoring committee. Currently, the new drug application for this regimen has been accepted by the NMPA and included in the priority review and approval process. The following results were published simultaneously in the New England Journal of Medicine at the time of presentation at the 2026 ESMO Congress. KN026-001/KC-WISE is a randomized, double-blind, controlled, multicenter Phase III clinical study designed to evaluate the efficacy and safety of anbenitamab in combination with chemotherapy in patients with HER2+ GC/GEJ who had failed at least one prior line of therapy. Enrolled patients with HER2+ GC/GEJ (who had disease progression after receiving trastuzumab-based therapy) were randomized to receive either anbenitamab in combination with chemotherapy (treatment group) or placebo in combination with chemotherapy (control group). At the 2025 ESMO Congress, the KC-WISE study announced the results of the first interim analysis, showing that anbenitamab in combination with chemotherapy achieved clinically meaningful and statistically significant benefits in both PFS and OS compared with placebo in combination with chemotherapy, with a well-tolerated and controllable safety profile. For details, please refer to the Company's announcement dated October 17, 2025. This regimen was approved for marketing through the NMPA priority review and approval process in May 2026. At this ESMO Congress, the prespecified interim OS analysis results of the KC-WISE study were updated.