Alphamab-B (09966) announced that significant results from the Phase III clinical study (KN026-004) evaluating anitotumab (commercial name: Ennitot®, R&D code: KN026) in combination with docetaxel injection (albumin-bound) (HB1801) for the neoadjuvant treatment of HER2-positive breast cancer (BC), developed in collaboration with JMT Bio, a subsidiary of CSPC Pharmaceutical Group, have been presented as a late-breaking oral abstract at the 2026 ASCO Annual Meeting. KN026-004 is a randomized, controlled, open-label, multicenter Phase III study designed to assess the efficacy and safety of anitotumab combined with HB1801 ± carboplatin versus trastuzumab plus pertuzumab and docetaxel ± carboplatin in the neoadjuvant setting for early or locally advanced HER2+ BC. The primary endpoint was total pathological complete response (tpCR) as assessed by Blinded Independent Review Committee (BIRC). Patients with early or locally advanced HER2+ BC were randomized in a 1:1 ratio to receive six cycles of either the anitotumab combination regimen (anitotumab group) or the trastuzumab/pertuzumab combination regimen (THP±Cb group). Stratification factors included (i) clinical stage, (ii) hormone receptor status, and (iii) planned use of carboplatin. In the neoadjuvant treatment of early or locally advanced HER2+ BC, the anitotumab combined with HB1801 ± carboplatin regimen demonstrated a significant improvement in tpCR rate compared to the existing standard dual HER2 blockade plus chemotherapy regimen, with a manageable safety profile. These results support the potential of the anitotumab-based regimen to become a new standard therapy for neoadjuvant treatment in this patient population.