ALPHAMAB-B (09966) announced that the Phase III clinical study (Study Code: KN026-004) evaluating KN026 in combination with docetaxel for injection (albumin-bound) (HB1801) as a neoadjuvant treatment for human epidermal growth factor receptor 2 (HER2) positive breast cancer has met its primary endpoint. The study, developed in collaboration with a subsidiary of a major pharmaceutical group, achieved a statistically significant and clinically meaningful improvement in the total pathological complete response rate (tpCR). Breast cancer is the most common malignant tumor among women in China, with the HER2-positive subtype accounting for approximately 20% to 30% of cases. In China, about 75% of breast cancer patients are diagnosed at an early or localized stage. Surgery combined with neoadjuvant and/or adjuvant therapy is a core strategy for achieving a cure in early or locally advanced breast cancer. Research indicates that patients who achieve tpCR after neoadjuvant therapy experience significant improvements in both event-free survival (EFS) and overall survival (OS), with this benefit being particularly pronounced in HER2-positive breast cancer. However, only about half of patients with early or locally advanced HER2-positive breast cancer achieve tpCR after receiving the standard neoadjuvant regimen of trastuzumab combined with pertuzumab and chemotherapy (THP/TCbHP). Furthermore, the goals of neoadjuvant therapy extend beyond increasing tpCR to include creating conditions for earlier surgical intervention. Therefore, there remains a clinical need to explore more effective neoadjuvant regimens that allow for earlier surgery. The Neo-Healer (KN026-004) trial is a randomized, controlled, open-label, multicenter, Phase III clinical study planned to enroll approximately 520 patients with early or locally advanced HER2-positive breast cancer, randomized in a 1:1 ratio. The study aims to compare the efficacy and safety of KN026 combined with HB1801 ± carboplatin versus trastuzumab combined with pertuzumab and docetaxel ± carboplatin as neoadjuvant treatment for early and locally advanced HER2-positive breast cancer. The primary endpoint of the study is tpCR assessed by a blinded independent review committee (BIRC). Results show that KN026 combined with HB1801 ± carboplatin significantly improved tpCR compared to the current standard of care. Detailed data from the study will be presented at an upcoming international academic conference.