SAN FRANCISCO, Dec. 16, 2025 /PRNewswire/ — Biostar Pharma, Inc., the U.S. wholly-owned subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Stock Code: 2563.HK), today announced that the first patient has been dosed for one of its key oversea clinical studies: the U.S. pivotal clinical study (NCT06764940) of Utidelone Injection(UTD1) combined with capecitabine for the treatment of HER2-negative breast cancer brain metastases (BCBM).
The study adopts a two-stage design and plans to enroll approximately 120 subjects. The primary endpoint is the central nervous system objective response rate (CNS-ORR). Nearly 20 top tier clinical institutes across the United States are participating in the trial, including MD Anderson Cancer Center, John Hopkins Sidney Kimmel Comprehensive Cancer Center, City of Hope-Duarte, Robert H. Lurie Comprehensive Cancer Center at Northwestern University, University of Colorado Hospital, Augusta University, and University of California Los Angeles.
Utidelone’s unique physicochemical properties and insensitivity to P-glycoprotein-mediated efflux enable it to cross the blood-brain barrier (BBB) and prevent or treat brain metastases of solid tumors, setting it apart from taxanes, which are also microtubule stabilizers. A Phase II clinical study of utidelone combined with bevacizumab and chemotherapy for HER2-negative BCBM, which enrolled 34 subjects, was presented orally at the 2025 ASCO Annual Meeting [1]. The results showed a CNS-ORR of 67.6%, a central nervous system clinical benefit rate (CNS-CBR) of 88.2%, and a median central nervous system progression-free survival (CNS-PFS) of 15 months. The results of another Phase II clinical study of utidelone combined with bevacizumab for HER2-negative BCBM were published in JAMA Oncology in 2025 [2]. 47 subjects were recruited in the study, with a CNS-ORR of 42.6%, a median CNS-PFS of 10.6 months, and a median overall survival of 15.1 months. In both studies, most treatment-related adverse events (TRAEs) were Grade 1-2, controllable, and reversible. The U.S. FDA has also granted Utidelone orphan drug designation for the treatment of breast cancer brain metastases.
Approximately 20-50% of advanced breast cancer patients develop brain metastases [3]. Due to the presence of the BBB, many breast cancer treatments were unable to achieve effective concentrations intracranially, leading to generally poor prognoses for BCBM patients, particularly those with HER2-negative BCBM, whose median progression-free survival is only 2-6 months. However, there is currently no clearly effective drug therapy for HER2-negative BCBM, and no drugs worldwide have been approved for this indication, highlighting a significant and urgent unmet medical need. Utidelone has the potential to change this landscape, offering a new treatment option and hope for survival to these patients.
About Biostar
Biostar is an integrated biopharma company focusing on the development of innovative anti-cancer drugs utilizing its synthetic biology R&D platform. The company is listed on the Hong Kong Stock Exchange (HK 2563) in 2024. We are actively selecting reliable global partners through out-licensing or co-development of Utidelone assets. We believe that our strong capabilities of R&D and manufacturing, coupled with our enriched commercial expertise, make us the preferred partner for global biopharmaceutical companies who share our goal of bringing innovative anti-cancer products to patients around the world. For additional information on partnering with Biostar, please contact our business development team at bd@biostar-pharma.com.
References:
[1] 2025 ASCO Abstract #: 2012.
[2] JAMA Oncol. 2025;11;(8):883-889.
[3] Lin, N. U., et al. Soc. Clin. Oncol. Educ. Book 37, 45-56 (2017).
This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network
