Samsung Bioepis' first ADC candidate wins FDA Fast Track

What happened: Samsung Bioepis said its first antibody-drug conjugate candidate, SBE303, received FDA Fast Track designation. SBE303 targets Nectin-4 and is being developed for locally advanced or metastatic urothelial cancer patients who previously received a Nectin-4-targeted therapy. Why it matters: The designation is expected to help Samsung Bioepis identify and address development risks and manage the regulatory process more closely as SBE303 advances. SBE303 is the company's first novel medicine candidate, expanding beyond its biosimilar business.

Samsung Bioepis said its first antibody-drug conjugate candidate, SBE303, received FDA Fast Track designation. SBE303 targets Nectin-4 and is being developed for locally advanced or metastatic urothelial cancer patients who previously received a Nectin-4-targeted therapy.

The designation is expected to help Samsung Bioepis identify and address development risks and manage the regulatory process more closely as SBE303 advances. SBE303 is the company's first novel medicine candidate, expanding beyond its biosimilar business.