ALPHAMAB-B(09966): The new drug application for Anritanib (KN026) as a first-line treatment for HER2-positive advanced breast cancer has been accepted by the National Medical Products Administration.

ALPHAMAB-B (09966) announced that its application for new drug approval (NDA) for the combination therapy of Anitunmab (trade name: Enituo, R&D code: KN026) and Injectable Docetaxel (albumin-bound) (HB1801) as a first-line treatment for unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive (HER2+) adult breast cancer has been accepted by the National Medical Products Administration (NMPA) of China and has entered the priority review and approval process. Previously, the combination therapy of Anitunmab and HB1801 for this indication was granted breakthrough therapy designation by the NMPA. This NDA is primarily based on a key Phase III clinical study (Study No.: KN026-003/Healer). The results showed that the combination therapy of Anitunmab and HB1801 significantly improved progression-free survival (PFS) compared to the current standard treatment of Trastuzumab combined with Pertuzumab and Docetaxel (THP regimen), with significant statistical significance and clear clinical benefits, while overall safety was good. Detailed data from this study will be presented at an upcoming international academic conference. In China, approximately 20% of breast cancer patients are diagnosed at an advanced stage, and about 10% of HER2+ early breast cancer patients may experience disease recurrence within three years after curative surgery. The THP regimen remains the preferred first-line treatment for HER2+ advanced breast cancer both domestically and internationally. Despite this treatment regimen significantly extending the PFS for such patients, about 50% of patients still experience disease progression within two years, indicating an urgent clinical need for new treatments. The KN026-003/Healer study is the world's first Phase III study demonstrating that HER2 dual antibody combination therapy can surpass the efficacy of the THP regimen in HER2+ advanced breast cancer, achieving a historic breakthrough in first-line treatment for HER2+ advanced breast cancer and is expected to provide a more effective, safer, and more convenient new treatment option for Chinese HER2+ advanced breast cancer patients. Currently, the combination therapy of Anitunmab and HB1801 has completed a comprehensive clinical layout for neoadjuvant, adjuvant, and advanced first-line treatment of HER2+ breast cancer. Among these, the NDA for the neoadjuvant treatment of early or locally advanced HER2+ adult breast cancer has also been accepted by the NMPA and included in the priority review and approval process.