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Breaking the "Untreatable": Biostar Pharma's UTD1 Achieves First Patient Dosing in U.S. for Pivotal Clinical Trial for Breast Cancer Brain Metastases
Utidelone combined with capecitabine targets HER2-negative breast cancer brain metastases, addressing an unmet need with a 67.6% CNS objective response rate in prior studies.
- Biostar Pharma, Inc. announced the first patient was dosed in the U.S. pivotal study NCT06764940 testing Utidelone Injection plus capecitabine, supporting potential treatment for HER2‑negative breast cancer brain metastases.
- Because no approved therapies exist for HER2‑negative breast cancer brain metastases , Utidelone's properties enable blood–brain barrier penetration by avoiding P‑glycoprotein–mediated efflux, unlike taxanes.
- Phase II results showed promising intracranial activity, reporting CNS‑ORR 67.6%, CNS‑CBR 88.2%, median CNS‑PFS 15 months, plus earlier studies with 34 subjects and 47 subjects showing mixed CNS responses.
- The U.S. FDA has granted Utidelone orphan drug designation for breast cancer brain metastases, with most treatment‑related adverse events Grade 1–2, controllable, as Biostar Pharma, Inc. seeks global partners while listed on the Hong Kong Stock Exchange .
- Approximately 20–50% of advanced breast cancer patients develop brain metastases, so if confirmed, the U.S. pivotal study could impact a large patient population.
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Breaking the 'Untreatable': Biostar Pharma's UTD1 Achieves First Patient Dosing in U.S. for Pivotal Clinical Trial for Breast Cancer Brain Metastases
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...
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Breaking the "Untreatable": Biostar Pharma's UTD1 Achieves First Patient Dosing in U.S. for Pivotal Clinical Trial for Breast Cancer Brain Metastases
SAN FRANCISCO, Dec. 15, 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:…
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