OBI-902 has received orphan drug designation from the U.S. FDA for the treatment of bile duct cancer.
Taipei, Taiwan, November 17, 2025 - (JCN Newswire) - OBI Pharma (4174.TWO), a clinical-stage oncology company, announced that its TROP2 ADC "OBI-902," which was submitted for the treatment of cholangiocarcinoma, has received orphan drug designation from the U.S. Food and Drug Administration (FDA). OBI-902 is OBI's first ADC incorporating OBI's proprietary glycan site-specific binding ADC creation technology.
Cholangiocarcinoma is a rare and highly lethal malignant tumor, with fewer than 50,000 patients in the U.S., and a five-year survival rate ranging from 2% to 23% depending on disease stage, histological type, and lesion site. Currently, there are no FDA-approved ADC therapies for cholangiocarcinoma.
To promote the development of new treatment options for rare diseases, the U.S. FDA grants orphan drug designation to investigational therapies that have the potential to treat these conditions.

Inquiry about this news
Contact Us Online




