SN Bioscience's SNB-101 Secures FDA Orphan Drug Designation for Gastric Cancer

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SN Bioscience's SNB-101 Secures FDA Orphan Drug Designation for Gastric Cancer

SN Bioscience, led by CEO Young Hwan Park, has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its investigational cancer therapy SNB-101 for the treatment of gastric cancer, including gastroesophageal junction cancer.

SNB-101 is a polymer nanoparticle–based anticancer drug that uses SN-38, a highly potent but extremely insoluble active pharmaceutical ingredient. By formulating SN-38 into polymer nanoparticles, SN Bioscience aims to significantly enhance therapeutic efficacy while reducing systemic side effects. The drug is currently in phase 1b/2 clinical trials for small cell lung cancer and is also being actively evaluated for multiple solid tumor indications across Korea, Europe, and the US.

Gastric cancer is classified as a rare disease in the US, with a prevalence of fewer than 200,000 patients and an overall five-year relative survival rate of approximately 36 percent. Treatment options for advanced gastric cancer remain limited, with standard-of-care regimens largely relying on cytotoxic chemotherapies such as irinotecan and paclitaxel, along with targeted therapies like trastuzumab for HER2-positive patients. Despite these treatments, the prognosis for advanced-stage patients remains poor, as many eventually develop resistance or experience disease progression.

According to SN Bioscience, SNB-101 has demonstrated superior efficacy compared with existing standard treatments, including paclitaxel, irinotecan, and trastuzumab, in preclinical gastric cancer animal models, highlighting its potential as a next-generation therapeutic option.

The FDA’s Orphan Drug Designation program is designed to encourage the development of therapies for rare, life-threatening, or incurable diseases. Drugs that receive ODD are eligible for several incentives, including seven years of market exclusivity upon approval, tax credits for clinical research costs, exemption from FDA application fees, regulatory guidance during clinical development, and eligibility for priority review.

SNB-101 has previously received FDA Orphan Drug Designations for small-cell lung cancer in July 2023 and pancreatic cancer in February 2024.

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Anticancer drugs Gastric Cancer Orphan Drug Designation SN Bioscience US Food and Drug Administration USFDA Young Hwan Park

More news about: global pharma | Published by Abha | December - 29 - 2025

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