FDA Grants Orphan Designation to Yisheng’s Immunotherapy for Liver Cancer

The FDA granted an Orphan Drug Designation to YS-ON-001, developed by Yisheng Biopharma, for the treatment of hepatocellular carcinoma. The immunotherapeutic effects of the biologic have been studied in preclinical animal studies in multiple solid tumors.

Orphan drug designation is granted to drugs and biologics intended for rare diseases that affect fewer than 200,000 people in the U.S., and provides incentives that may include tax credits trials and user fee waivers. The designation would also entitle Yisheng Biopharma to a seven-year period of marketing exclusivity in the U.S.