FDA Grants Orphan Drug Designation to Biostar Pharma's Utidelone for Treatment of Pancreatic Cancer
**Biostar Pharma's Utidelone Receives FDA Orphan Drug Designation for Pancreatic Cancer** SAN FRANCISCO, Sept. 25, 2025 - Biostar Pharma, Inc., a wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd., has announced that its core pipeline product, Utidelone, has been granted Orphan Drug Designation $(ODD)$ by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This marks the third ODD for Utidelone, following previous designations for breast cancer brain metastases and gastric cancer. The FDA's decision is based on promising preclinical and early clinical results, including a Phase II study showing an objective response rate of 27.27% and a disease control rate of 72.72% in advanced, unresectable pancreatic cancer. No other organizations were named as recipients of this regulatory designation. Pancreatic cancer remains one of the most challenging malignancies to treat, with a five-year survival rate of just 10%. Utidelone's new designation highlights the ongoing effort to improve therapeutic options for this devastating disease.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Beijing Biostar Pharmaceuticals Co. Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN83154) on September 25, 2025, and is solely responsible for the information contained therein.
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