Huahao Zhongtian Pharmaceutical-B (02563): Medication for the first case of patients in a key clinical study of breast cancer and brain metastasis in the US

Zhitong Finance App News, Huahao Zhongtian Pharmaceutical-B (02563) announced that Biostar Pharma, Inc. (US-BioStar), a wholly owned US subsidiary of the company, has completed the first patient administration of an important overseas clinical study: UTD1 combined with capecitabine to treat HER2 negative breast cancer brain metastasis (BCBM) in the US Key Registered Clinical Study (NCT06764940).

The study used a two-phase design, and a total of about 120 subjects were proposed. The main end point of the study was central nervous system objective response rate (CNS-ORR). Organized by MD Anderson Cancer Center (MD Anderson Cancer Center), John Hopkins Sidney Kimmel Comprehensive Cancer Center (John Hopkins Sidney Kimmel Comprehensive Cancer Center), City of Hope-Duarte (City of Hope-Duarte), and Northwestern University Cancer Center (Robert H. Lurie Comprehensive Cancer Center) Nearly 20 head research centers from all over the US, including Northwestern University), the University of Colorado Hospital (University of Colorado Hospital), Augusta University (Augusta University), and the University of California Los Angeles (University of California Los Angeles), participated.

Utilon's unique physico-chemical properties and advantages such as insensitivity to P-glycoprotein-mediated external excretion make it capable of penetrating the blood-brain barrier (BBB) and preventing brain metastasis in solid tumors, in stark contrast to yew drugs, which are also microtubule stabilizers. An oral report at the 2025 ASCO conference included 34 patients in the clinical phase II study of Utedron combined with bevacizumab and chemotherapy for HER2 negative BCBM. The results showed that CNS-ORR was 67.6%, the central nervous system clinical benefit rate (CNS-CBR) was 88.2%, and the median survival without progress in the central nervous system (CNS-PFS) was 15 months; the other was published in the 2025 JAMA Oncology journal. A total of 47 patients were included in the study. Results showed CNS-ORR of 42.6%, median CNS-PFS of 10.6 months, and median overall survival of 15.1 months. Most treatment-related adverse events (TRAEs) in the two studies were grade 1-2, and were controllable and reversible. Utiltron has also been qualified by the US FDA as an orphan drug to treat breast cancer brain metastases.

About 20— 50% of patients with advanced breast cancer will have brain metastases. Due to the presence of BBB, it is difficult for many breast cancer treatment drugs to achieve effective concentrations in the brain, so BCBM patients generally have poor prognosis. In particular, HER2 negative BCBM patients have a worse prognosis. The median progression-free survival time is only 2 to 6 months. However, HER2-negative BCBM still lacks a clear and effective drug treatment plan. There is no drug approved for HER2-negative BCBM worldwide, and there is an obvious and urgent unmet clinical need. Utilon is expected to change the status quo and bring new treatments and survival hopes to such patients.