{"id":41685,"date":"2025-12-16T11:55:00","date_gmt":"2025-12-16T04:55:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=41685"},"modified":"2025-12-16T11:55:00","modified_gmt":"2025-12-16T04:55:00","slug":"breaking-the-untreatable-biostar-pharmas-utd1-achieves-first-patient-dosing-in-u-s-for-pivotal-clinical-trial-for-breast-cancer-brain-metastases","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=41685","title":{"rendered":"Breaking the “Untreatable”: Biostar Pharma’s UTD1 Achieves First Patient Dosing in U.S. for Pivotal Clinical Trial for Breast Cancer Brain Metastases"},"content":{"rendered":"

SAN FRANCISCO<\/span>, Dec. 16, 2025 \/PRNewswire\/ — Biostar Pharma, Inc., the U.S. wholly-owned subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Stock Code:\u00a02563.HK<\/span>),\u00a0today 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).<\/span><\/p>\n

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<\/span> are participating in the trial, including MD Anderson Cancer Center, John Hopkins Sidney Kimmel Comprehensive Cancer Center, City of Hope-Duarte<\/span>, Robert H. Lurie Comprehensive Cancer Center at Northwestern University<\/span>, University of Colorado<\/span> Hospital, Augusta University, and University of California Los Angeles<\/span>.<\/p>\n

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]<\/sup>. 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]<\/sup>. 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.<\/p>\n

Approximately 20-50% of advanced breast cancer patients develop brain metastases [3]<\/sup>. 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.<\/p>\n

About Biostar<\/b><\/p>\n

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<\/a>.<\/span><\/p>\n

\n\n\n\n
\n

References:<\/span><\/p>\n

[1] 2025 ASCO Abstract #: 2012.<\/span><\/p>\n

[2] JAMA Oncol. 2025;11;(8):883-889.<\/span><\/p>\n

[3] Lin, N. U., et al. Soc. Clin. Oncol. Educ. Book 37, 45-56 (2017).<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

SAN FRANCISCO<\/span>, Dec. 16, 2025 \/PRNewswire\/ — Biostar Pharma, Inc., the U.S. wholly-owned subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Stock Code:\u00a02563.HK<\/span>),\u00a0today 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).<\/span><\/p>\n

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<\/span> are participating in the trial, including MD Anderson Cancer Center, John Hopkins Sidney Kimmel Comprehensive Cancer Center, City of Hope-Duarte<\/span>, Robert H. Lurie Comprehensive Cancer Center at Northwestern University<\/span>, University of Colorado<\/span> Hospital, Augusta University, and University of California Los Angeles<\/span>.<\/p>\n

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]<\/sup>. 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]<\/sup>. 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.<\/p>\n

Approximately 20-50% of advanced breast cancer patients develop brain metastases [3]<\/sup>. 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.<\/p>\n

About Biostar<\/b><\/p>\n

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<\/a>.<\/span><\/p>\n

\n\n\n\n
\n

References:<\/span><\/p>\n

[1] 2025 ASCO Abstract #: 2012.<\/span><\/p>\n

[2] JAMA Oncol. 2025;11;(8):883-889.<\/span><\/p>\n

[3] Lin, N. U., et al. Soc. Clin. Oncol. Educ. Book 37, 45-56 (2017).<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

\u00a0<\/p>\n

<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-41685","post","type-post","status-publish","format-standard","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/41685","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=41685"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/41685\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=41685"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=41685"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=41685"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}