Samsung Bioepis wins FDA Fast Track for 1st anticancer drug candidate
Samsung Bioepis has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SBE303, an anticancer drug candidate based on antibody-drug conjugate (ADC) technology, the company said Wednesday. SBE303 is the first novel drug candidate in Samsung Bioepis' pipeline. It is an ADC, a type of biopharmaceutical drug designed to deliver powerful cancer-killing agents directly…
Samsung Bioepis has secured Fast Track designation from the U.S. Food and Drug Administration (FDA) for its anticancer drug candidate, SBE303. This novel drug, based on antibody-drug conjugate (ADC) technology, is the first in Samsung Bioepis' pipeline. As an ADC, SBE303 is designed to deliver potent cancer-killing agents directly to cancer cells while minimizing harm to healthy tissues.
The drug targets Nectin-4, a cell adhesion protein found in several types of cancer, including urothelial, lung, and breast cancers. Samsung Bioepis has tailored SBE303 to overcome the limitations of existing ADCs targeting Nectin-4, which often suffer from a narrow therapeutic window. By using its proprietary linker, Samsung Bioepis aims to enhance the drug's efficacy and safety profile.
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- Samsung Bioepis Receives FDA Fast Track Designation for SBE303 businesskorea.co.kr
- Samsung Bioepis wins FDA Fast Track for 1st anticancer drug candidate koreatimes.co.kr
