华昊中天医药-B：优替德隆治疗乳腺癌脑转移美国关键临床研究首例患者用药

Core Viewpoint - Huahao Zhongtian Pharmaceutical-B (02563) announced that its wholly-owned U.S. subsidiary, Biostar Pharma, Inc. (US-Biostar), has completed the first patient dosing in a significant overseas clinical study for UTD1 combined with capecitabine to treat HER2-negative breast cancer brain metastases (BCBM) in a pivotal registration trial in the U.S. (NCT06764940) [1] Group 1 - The study employs a two-stage design, aiming to enroll approximately 120 subjects, with the primary endpoint being the central nervous system objective response rate (CNS-ORR) [2] - Nearly 20 leading research centers across the U.S., including MD Anderson Cancer Center and Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, are participating in the study [2] Group 2 - UTD1's unique physicochemical properties and insensitivity to P-glycoprotein-mediated efflux allow it to penetrate the blood-brain barrier (BBB) and combat solid tumor brain metastases, contrasting sharply with taxane drugs [3] - A clinical phase II study presented at the 2025 ASCO conference involving UTD1 combined with bevacizumab and chemotherapy for HER2-negative BCBM included 34 patients, showing a CNS-ORR of 67.6% and a CNS clinical benefit rate (CNS-CBR) of 88.2%, with a median CNS progression-free survival (CNS-PFS) of 15 months [3] - Another phase II study published in the 2025 JAMA Oncology journal included 47 patients, reporting a CNS-ORR of 42.6%, a median CNS-PFS of 10.6 months, and a median overall survival of 15.1 months, with most treatment-related adverse events (TRAEs) being grade 1-2 and manageable [3] Group 3 - Approximately 20-50% of advanced breast cancer patients experience brain metastases, with poor prognosis for HER2-negative BCBM patients, who have a median progression-free survival of only 2-6 months [4] - There is a significant and urgent unmet clinical need for effective drug treatments for HER2-negative BCBM, as no drugs have been approved globally for this condition [4] - UTD1 is expected to change the current treatment landscape and provide new therapeutic options and survival hope for these patients [4]