Samsung Bioepis' First Novel Drug Candidate Granted U.S. FDA Fast Track Designation

ADC Anticancer Drug SBE303
Nectin-4-Targeting Treatment for Urothelial Carcinoma
Expanded Opportunities to Engage with the FDA from Early Development

Samsung Bioepis said on Oct. 21 that SBE303, its first novel drug candidate, an antibody-drug conjugate (ADC) cancer treatment, has been designated for the U.S. Food and Drug Administration’s (FDA) Fast Track program.

SBE303 is an ADC therapy that targets nectin-4, a protein overexpressed in tumor cells. It is the first novel drug in Samsung Bioepis’ development pipeline. The designation applies to patients with locally advanced or metastatic urothelial carcinoma who have previously received treatment targeting nectin-4.

Samsung Bioepis headquarters in Songdo, Incheon. Samsung Bioepis

The FDA Fast Track program supports the development and review of drugs with the potential to treat serious conditions for which existing treatments have limitations. Designated drugs may have more opportunities to communicate with the FDA from the early stages of development. Samsung Bioepis expects the designation to help it address regulatory risks and manage the development process for SBE303.

Jung Byungin, head of the Regulatory Affairs (RA) team at Samsung Bioepis and an executive vice president, said, "The FDA Fast Track designation recognizes SBE303's potential to address unmet medical needs as a treatment for a serious disease. It also enables us to demonstrate that we have globally competitive research and development capabilities in novel drug development."

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