Beijing Biostar Pharmaceuticals Co. Ltd. announced the dosing of the first patient in a pivotal U.S. clinical trial (NCT06764940) evaluating Utidelone Injection (UTD1) in combination with capecitabine for the treatment of HER2-negative breast cancer brain metastases (BCBM). The study, involving approximately 120 subjects across nearly 20 clinical centers in the United States, uses a two-stage design with the primary endpoint of central nervous system objective response rate (CNS-ORR). Previous clinical results with utidelone in combination therapies for HER2-negative BCBM have been presented, including a Phase II study reported at the 2025 ASCO Annual Meeting and another published in JAMA Oncology in 2025, demonstrating CNS-ORR rates of 67.6% and 42.6%, respectively. The U.S. FDA has granted Utidelone orphan drug designation for the treatment of breast cancer brain metastases.