The U.S. Food and Drug Administration (FDA) has granted Yisheng Biopharma orphan drug designation (ODD) for its lead immuno-oncology candidate, YS-ON-001, for the treatment of pancreatic cancer.  

To date, the FDA has granted YS-ON-001 two ODDs for the treatment of pancreatic cancer and hepatocellular carcinoma.   YS-ON-001 is a clinical-stage immuno-oncology biologic product with unique immunomodulating mechanism and broad spectrum of anti-tumor activity.

Dr. Hui Shao, the president and chief executive officer of Yisheng Biopharma, commented, “The orphan drug designation of YS-ON-001 in pancreatic cancer is an important regulatory milestone as it will accelerate our clinical development in this particular oncology indication where pancreatic cancer is one of the deadliest cancers and is estimated to be the  fourth leading cause of cancer-related death in the United States in 2018, according to the American Cancer Society.”

The orphan drug designation also entitles Yisheng Biopharma to a seven-year period of marketing exclusivity in the United States pending FDA approval for the treatment of liver cancer.