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SN BioScience received US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug 'SNB-101' on Gastric Cancer.
SNB-101, a polymer nanoparticle anticancer drug, received orphan status to boost development for rare gastric cancer with a 36% five-year survival rate, US FDA said.
- US Food and Drug Administration action on December 24, 2025, granted Orphan Drug Designation to SNB-101 for gastric cancer, SN BioScience announced the same day.
- Because gastric cancer is rare and has poor survival, the US classifies it as extremely rare with prevalence <200,000 and 5-year relative survival about 36%, while Orphan Drug Designation offers incentives including seven years exclusivity and tax credits.
- Using dual nano-micelle technology, SNB-101 has completed Phase 1 and received IND approval for Phase 1b/2, according to SN BioScience.
- Under the Orphan Drug Designation, the FDA facilitates development and approval of treatments for rare diseases, and SN Bioscience says the ODD should accelerate indication expansion and clinical momentum for SNB-101.
- Because many patients progress after first-line therapy, SN Bioscience says SNB-101 showed excellent efficacy versus paclitaxel, irinotecan and trastuzumab in preclinical gastric cancer animal models.
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SN BioScience received US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug 'SNB-101' on Gastric Cancer.
SEONGNAM, South Korea, Dec. 23, 2025 /PRNewswire/ -- SN Bioscience Inc. (CEO Young Hwan PARK) announced that the FDA had granted Orphan Drug Designation (ODD) on December 10 for gastric cancer (including gastroesophageal junction cancer) to SNB-101 (API: SN-38) which…
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