ALPHAMAB-B (09966.HK) announced that the New Drug Application (NDA) for Anniutuo (brand name: Ennituo®, development code: KN026), developed in collaboration with CSPC Pharmaceutical Group (01093.HK) subsidiary Shanghai Jinmant Biotechnology Co., Ltd., has been accepted by China's National Medical Products Administration (NMPA). The drug, combined with Docetaxel (albumin-bound) injection (HB1801), is intended for neoadjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive (HER2+) early or locally advanced breast cancer. The application has also been granted priority review status.

This NDA is primarily based on a pivotal Phase III clinical trial (study number: KN026-004/Neo-Healer), which enrolled patients with early or locally advanced HER2+ breast cancer. Study results indicate that neoadjuvant therapy with Anniutuo combined with HB1801, with or without carboplatin, significantly improved the total pathological complete response (tpCR) rate compared to the standard of care (trastuzumab plus pertuzumab and docetaxel, with or without carboplatin). The tpCR assessed by the Blinded Independent Review Committee (BIRC) was 62.4% (95% CI: 56.20~68.23), with a one-sided P-value of 0.0036, establishing a superior efficacy conclusion with both statistical and clinical significance. The overall safety profile was also manageable.