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 is a polymer nanoparticle drug under phase 1b/2 clinical trial for small cell lung cancer.

SNB-101 is the world's first nanoparticle anticancer drug that has formulated extremely insoluble SN-38 into polymer nanoparticles, which is expected to significantly improve therapeutic efficacy and reduce side effects. It is currently undergoing active clinical development for various solid tumor indications in Korea, Europe, and the U.S.A.

Gastric cancer is classified as an extremely rare disease (with a prevalence <200,000) in the U.S. with a 5-year relative survival rate of only about 36% across all stages. Currently, the standard of care for advanced gastric cancer includes cytotoxic chemotherapy (such as irinotecan and paclitaxel) and targeted therapies like trastuzumab for HER2-positive patients. However, the prognosis for patients with advanced stages remains poor. Many patients eventually develop resistance to these first-line treatments or experience disease progression, leaving them with limited effective therapeutic options. According to SN Bioscience, SNB-101 showed excellent efficacy compared to existing standard of care treatments such as paclitaxel, irinotecan and trastuzumab in gastric cancer animal models.

Orphan drug designation is a program where the US FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. This designation provides the qualified drug developers with various benefits such as exclusive rights for 7 years from the date of marketing approval, tax credits for R&D costs, assistance for clinical trial design for clinical development, exemption from review application fees, and priority review support.

SNB-101 previously received ODDs from the US FDA for small cell lung cancer in July 2023 and pancreatic cancer in February 2024. By receiving an ODD for gastric cancer this time, SN Bioscience expects to gain momentum in indication expansion and clinical development.

About SN BioScience Inc.

SN BioScience is a biotech company established in May 2017. It is a drug delivery system R&D company specialized in anti-cancer drugs and is located in South Korea. SN BioScience was founded by pharmaceutical R&D experts, world-class bio-polymer research professors, and clinical professors. From the beginning of its establishment, it has focused on "commercialization" and has been developing nanoliposomes and nanoparticle drug carriers based on pharmacometrics and pharmacokinetics.

SNB-101

SNB-101 is an anticancer agent that is the world's first nanoparticle formulation of the anticancer drug SN-38. It uses a delivery system sophisticatedly designed via dual nano-micelle technology which is a core platform technology of SN Bioscience. SN-38 is an active metabolite of irinotecan which is gaining attention for its use in antibody-drug conjugates (ADCs) such as Enhertu® and Trodelvy®. Compared to existing irinotecan products, drug resistance and safety have been significantly improved, and based on the animal studies, it is expected to be effective for lung cancer, pancreatic cancer, and stomach cancer, which were not the indications previously.

SNB-101 successfully completed Phase 1 clinical trials in patients with solid tumors (NCT04640480) and received IND approval for Phase 1b/2 from the US FDA in December 2024 for the treatment of small cell lung cancer. Subsequently, a regulatory protocol review is currently underway in Europe for phase 2 trials, which will evaluate both monotherapy and combination therapy in patients with small cell lung cancer.

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SOURCE SN BioScience Inc.