Beijing Biostar Technologies Ltd (HKG: 2563) announced that its wholly‑owned U.S. subsidiary, Biostar Pharma, Inc., has completed the first patient dosing in a U.S. pivotal registration clinical trial (NCT06764940) evaluating Utedelone in combination with capecitabine for HER2‑negative Breast Cancer Brain Metastasis (BCBM). Utedelone, a genetically engineered epothilone derivative, was approved in China in March 2021 for recurrent/metastatic breast cancer.
Regulatory & Clinical Milestone
Item
Details
Study ID
NCT06764940
Trial Type
U.S. pivotal registration clinical trial
Population
HER2‑negative breast cancer brain metastasis (BCBM)
Regimen
Utedelone + capecitabine
First Patient Dosed
December 2025
Prior Approval
March 2021 (China) for recurrent/metastatic breast cancer post‑chemotherapy
Drug Profile & Competitive Advantages
Attribute
Utedelone
Competitive Context
Mechanism
Genetically engineered epothilone derivative
Microtubule stabilizer with broad anticancer spectrum
For Biostar:First US registration trial for a Chinese‑developed epothilone; validates global development capability; success would open ex‑China markets and support premium valuation.
For Chinese Biotech: Demonstrates capacity to execute US pivotal trials; regulatory pathway clarity for repurposing China‑approved drugs; potential template for other epothilone derivatives (e.g., utidelone’s success story).
For Patients:New therapeutic option for HER2‑negative BCBM, a population with limited targeted therapies; lower cost may improve access in both developed and emerging markets.
Forward‑Looking Statements This brief contains forward‑looking statements regarding Utedelone’s clinical development timeline, market penetration, and regulatory approval. Actual results may differ due to clinical risks, regulatory feedback, or competitive responses.-Fineline Info & Tech
By Fineline Cube 