Business
The FDA Granted Orphan Drug Designation to Biostar Pharma's Utidelone for the Treatment of Pancreatic Cancer
Biostar Pharma, Inc., the US wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd. ("Biostar," stock code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that its core pipeline product Utidelone has once again been granted as Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of pancreatic cancer. This mark
About this update from Beijing Biostar Pharmaceuticals Co., Ltd. Class H
[{"type":"text","content":"SAN FRANCISCO, Sept. 25, 2025 /PRNewswire/ -- Biostar Pharma, Inc., the US wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd. ("Biostar," stock code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that its core pipeline product Utidelone has once again been granted as Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of pancreatic cancer. This marks the third ODD granted to Utidelone by the FDA, following prior designations for breast cancer brain metastases and gastric cancer.","length":688,"tagName":"p"},{"type":"text","content":"Pancreatic cancer is a highly malignant tumor known as the "king of cancers" due to its insidious early symptoms, difficulty in diagnosis, rapid progression, strong invasiveness, and poor prognosis. The five-year survival rate is only approximately 10%, far lower than that of other common cancers, making it the lowest among all malignant tumors. Currently, there is no clearly effective treatment for pancreatic cancer. Combination regimens based on gemcitabine remain the main clinical treatment, but due to the high tendency of pancreatic cancer cells to develop resistance to gemcitabine, treatment outcomes are often unsatisfactory.","length":648,"tagName":"p"},{"type":"text","content":"The potential of Utidelone in treating pancreatic cancer has been well validated in both non-clinical and clinical studies[1]. Preclinical data show that Utidelone can significantly inhibit the proliferation and colony-forming ability of pancreatic cancer cells and exhibits strong anti-tumor activity in pancreatic cancer models. When combined with gemcitabine, Utidelone markedly reduces the IC50 value of gemcitabine without compromising its anti-tumor effect, and the combination demonstrates stronger anti-tumor activity compared with the traditional paclitaxel plus gemcitabine regimen. At the 2024 CSCO Annual Meeting, Biostar presented preliminary results from a multicenter, single-arm Phase II clinical study evaluating Utidelone combined with gemcitabine as first-line treatment for unresectable advanced pancreatic cancer. As of the report date, 20 advanced pancreatic cancer patients which were unresectable a...
More updates from Beijing Biostar Pharmaceuticals Co., Ltd. Class H