OBI-902 receives consecutive FDA Orphan Drug Designation indication expanded to gastric cancer including gastroesophageal junction adenocarcinoma

CAR-T Digest - August 2020

Weekly Digest - December 2025

05 December 2025: OBI-902 receives consecutive FDA Orphan Drug Designation indication expanded to gastric cancer including gastroesophageal junction adenocarcinoma

OBI Pharma has received a major boost in its oncology pipeline, as its TROP2-targeted ADC, OBI-902 secured a second US FDA Orphan Drug Designation, this time for gastric cancer and gastroesophageal junction cancer, just weeks after earning its first ODD for cholangiocarcinoma
This rapid succession of designations signals growing U.S. regulatory confidence in OBI-902’s potential, reinforcing the momentum behind the program and underscoring its promise in cancers with significant unmet medical need
With ODD status, OBI-902 gains access to valuable development incentives such as clinical trial tax credits, fee exemptions, and future marketing exclusivity, benefits that not only de-risk development but also strengthen the treatment’s commercial attractiveness and global partnership opportunities
The therapy itself stands out as the first ADC built on OBI’s proprietary GlycOBI site-specific glycan conjugation platform and is currently being evaluated in an ongoing Phase 1/2 clinical trial in the U.S. and Taiwan to assess its safety, pharmacokinetics, and early antitumor activity
The company noted that the consecutive FDA designations validate both OBI-902’s clinical potential and the strength of its GlycOBI technology, highlighting that addressing high-need cancers such as cholangiocarcinoma and gastric cancer could further expand global collaboration and commercialization opportunities