#South Korea #Seongnam #SN BioScience #Orphan Drug #Nano Drug

SN BioScience's Breakthrough in Cancer Treatment

Seongnam, South Korea - December 23, 2025 - SN BioScience Inc., under the leadership of CEO Young Hwan Park, has achieved a significant milestone in cancer treatment with its investigational drug SNB-101. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for SNB-101 on December 10, focusing on treatment for gastric cancer (including gastroesophageal junction cancer).

What is SNB-101?

SNB-101 is an innovative nanoparticle-based anticancer drug that encapsulates SN-38, an active metabolite of irinotecan, into polymer nanoparticles. Designed to tackle the challenges posed by the poor solubility of SN-38, this formulation aims to enhance the drug's therapeutic efficiency while minimizing side effects. Currently, SNB-101 is in phase 1b/2 clinical trials, particularly targeting small cell lung cancer, and is proving its potential across various solid tumor indications in regions including Korea, Europe, and the United States.

Significance of Gastric Cancer Awareness

Gastric cancer represents a major health concern, particularly in the U.S., where it is classified as a rare disease due to its prevalence being under 200,000 cases. The five-year relative survival rate stands at a disheartening 36%, highlighting the urgent need for new treatment options. Presently, advanced gastric cancer treatments primarily revolve around cytotoxic chemotherapy and targeted therapies, yet prognosis remains grim, often leading to resistance against first-line treatments. SNB-101 has demonstrated superior efficacy in preclinical models when set against existing treatment options like paclitaxel, irinotecan, and trastuzumab.

The Orphan Drug Designation Advantage

The Orphan Drug Designation program serves as a crucial catalyst for the development and approval of therapeutics for conditions that are rare or life-threatening. Under this designation, SNB-101 benefits from numerous incentives, including seven years of market exclusivity post-approval, tax credits for research and development expenses, assistance for clinical trial design, exemptions from certain fees, and priority review processes. This designation not only bolsters development for gastric cancer but also builds on SNB-101's previous ODDs for small cell lung cancer and pancreatic cancer.

Company Background and Core Objectives

Established in May 2017, SN BioScience is a South Korean biotechnology firm, highly regarded for its innovative drug delivery systems specialized in anti-cancer solutions. Founded by leading experts in pharmaceutical research and world-class biomaterials professors, the company aims to focus on commercialization strategies for its novel treatments. At the very core of its innovation is the advanced dual nano-micelle technology, which facilitates the precise delivery of therapeutic agents.

Future Prospects

SNB-101 not only embodies a beacon of hope for gastric cancer patients but signifies the company's foundational goal of pushing the boundaries of oncological therapeutics. Following successful completion of its Phase 1 clinical trials for solid tumors, and with IND approval for Phase 1b/2 trials focused on small cell lung cancer, there is a regulatory protocol review currently in progress for phase 2 trials in Europe. The outcome of these trials might expand treatment options further, potentially leading to remarkable progress in the realm of cancer care.

Conclusion

The receipt of Orphan Drug Designation by SNB-101 marks a notable step forward in the fight against gastric cancer. As the battle against cancer progresses, SN BioScience is poised to make substantial contributions to needed advancements in cancer care, reaffirming its commitment to innovate and provide new options for patients facing devastating diagnoses.