Biopharmaceutical company Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Biopharmaceuticals Co., Ltd. (HKG: 2563), announced on Thursday that the US Food and Drug Administration granted Orphan Drug Designation to its core pipeline product, Utidelone, for the treatment of pancreatic cancer.

This is the third such designation for Utidelone, which previously received approvals for breast cancer brain metastases and gastric cancer.

Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate of only about 10%. Current treatment relies primarily on gemcitabine-based combinations, though resistance often limits effectiveness.

Utidelone has shown promise in both preclinical and clinical studies. Results indicate that it significantly inhibits tumour growth, enhances the efficacy of gemcitabine, and outperforms traditional paclitaxel plus gemcitabine regimens.