OBI-902 has been granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma
TAIPEI, TAIWAN, Nov 17, 2025 – (ACN Newswire via SeaPRwire.com) – OBI Pharma, a clinical-stage oncology company (4174.TWO) received notification from the US FDA stating that the request for Orphan Drug Designation of OBI-902 TROP2 ADC for the treatment of Cholangiocarcinoma has been granted. OBI-902 is the first OBI-developed ADC that incorporates our proprietary site-specific glycan-conjugated ADC enabling technology.Cholangiocarcinoma is a rare and lethal malignancy with fewer than 50,000 patients in the United States and a 5-year survival rate ranging from 2% and 23% depending on disease stage, histological subtype, and localization 1 . At present, there are no FDA approved ADC therapies for cholangiocarcinoma.To encourage the industry to develop new treatment options for rare diseases, the US FDA grants Orphan Drug Designation to experimental therapies that have the potential to treat these diseases. In the United States, a rare disease is defined as any condition that affects fewer than 20…


















