SNB-101 showed excellent efficacy in animal small cell lung cancer models, and based on this, it has been designated as an orphan drug by the US FDA after application in April and review. Small cell lung cancer accounts for 15-20% of all lung cancers with a very poor prognosis. The current standard treatment (first-line treatment) is classic drugs, Cisplatin + Etoposide. However, as there are very limited options for second-line treatment and others, it is an area with very high medical unmet needs.

Orphan drug designation is a program where the FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. SN Bioscience expects the designation as an orphan drug to accelerate the development of SNB-101, which is being developed as a treatment for orphan drugs including small cell lung cancer.

Orphan drug 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 on clinical trial design for clinical development, exemption from review application fees, and priority review support.