SN BioScience, a South Korea–based biotech company, has secured Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its nano-formulated anticancer drug SNB‑101 for the treatment of gastric cancer, including gastroesophageal junction cancer. This designation, announced on December 10, 2025, expands SNB‑101’s orphan drug approvals, which already cover small cell lung cancer and pancreatic cancer.
SNB‑101 is a polymer nanoparticle formulation of SN-38, the active metabolite of irinotecan. The drug is designed to enhance solubility, improve therapeutic effectiveness, and reduce side effects commonly associated with traditional chemotherapy. SNB‑101 is currently undergoing Phase 1b/2 clinical trials for small cell lung cancer and is under development for multiple solid tumours across the U.S., Europe, and Korea, leveraging SN BioScience’s dual nano-micelle technology to optimise drug delivery.
Gastric cancer is considered a rare disease in the United States, affecting fewer than 200,000 people. Five-year survival rates remain low, particularly in advanced stages. Standard treatments such as irinotecan and paclitaxel, along with targeted therapies for specific molecular subtypes, often face limitations due to resistance or disease progression. Preclinical studies indicate that SNB‑101 demonstrates stronger antitumor activity compared with conventional treatments in gastric cancer models.
The FDA’s orphan drug designation provides benefits that include seven years of market exclusivity upon approval, tax credits for clinical development, guidance on trial design, exemptions from certain fees, and priority review, facilitating accelerated development for rare and serious diseases.
Founded in 2017, SN BioScience focuses on the development of nanoparticle-based cancer therapies and advanced drug delivery systems. The company has completed Phase 1 trials of SNB‑101 in solid tumour patients and obtained FDA IND approval in December 2024 for small cell lung cancer trials. Phase 2 regulatory submissions are ongoing in Europe to evaluate the drug both as monotherapy and in combination with other agents.
The new orphan designation is expected to support the broader development of SNB‑101, strengthening its potential as a treatment option for gastric cancer and other difficult-to-treat solid tumours.
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