ALPHAMAB-B (09966.HK): NDA for Anbenitamab Combination as First-Line Treatment for HER2-Positive Advanced Breast Cancer Accepted by NMPA

NewTimeSpace News: On 18 August 2026, Alphamab Oncology (stock code: 09966) announced that the new drug application for Anbenitamab (brand name Ennituo, development code KN026), developed in collaboration with CSPC Pharma's subsidiary Jinmant Biotech, in combination with docetaxel albumin-bound injection (HB1801) as first-line treatment for unresectable or metastatic HER2-positive adult breast cancer, has been accepted by the NMPA and included in the priority review procedure. The combination had previously been granted breakthrough therapy designation.

According to the announcement, the application is based on the pivotal Phase III study (KN026-003/Healer), which showed significantly superior progression-free survival versus the standard of care (trastuzumab plus pertuzumab and docetaxel), making it the world's first Phase III study of a HER2 bispecific antibody combination to demonstrate superiority over the standard regimen in this indication. Ennituo was approved for marketing in May 2026 for HER2-positive gastric cancer and has received FDA orphan drug designation. In August 2021, the Company granted Jinmant Biotech exclusive development and commercialisation rights for Anbenitamab in breast cancer and gastric cancer indications in mainland China.

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