OBI-902 has been granted by US FDA for Orphan Drug Designation for the treatment of cholangiocarcinoma

CAR-T Digest - August 2020

16 November 2025: OBI-902 has been granted Orphan Drug Designation by US FDA for the treatment of cholangiocarcinoma

OBI Pharma received FDA Orphan Drug Designation for OBI-902, a TROP2-targeting ADC developed using the company’s proprietary GlycOBI glycan-based conjugation technology
The designation focuses on cholangiocarcinoma, a rare and highly lethal cancer with fewer than 50,000 affected patients in the U.S. and no approved ADC therapies
Orphan status provides incentives such as tax credits, user-fee waivers, and marketing exclusivity to encourage development of treatments for rare diseases
OBI-902 entered an ongoing Phase I/II trial in August 2025 across the U.S. and Taiwan to evaluate its safety, pharmacokinetics, and early efficacy in advanced solid tumors
Preclinical findings highlight strong stability, potent bystander effect, potential to overcome drug resistance, and robust anti-tumor activity, positioning OBI-902 as a potentially best-in-class TROP2 ADC now being tested in patients