{
  "id": 15842832,
  "title": "Samsung Bioepis wins FDA Fast Track for 1st anticancer drug candidate",
  "url": "https://urgent.news/2026/10/21/samsung-bioepis-wins-fda-fast-track-for-1st-anticancer-drug-candidate-15842832",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-10-21T04:12:03.000Z",
  "source": {
    "name": "The Korea Times",
    "slug": "the-korea-times-koreatimes",
    "url": "https://www.koreatimes.co.kr/business/companies/20261021/samsung-bioepis-wins-fda-fast-track-for-1st-anticancer-drug-candidate"
  },
  "original_language": "en",
  "account": null,
  "summary": "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.",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 3,
    "also_reported_by": [
      {
        "outlet": "BusinessKorea",
        "title": "Samsung Bioepis Receives FDA Fast Track Designation for SBE303",
        "url": "https://urgent.news/2026/10/21/samsung-bioepis-receives-fda-fast-track-designation-for-sbe303",
        "published": "2026-10-21T01:57:53.000Z"
      },
      {
        "outlet": "The Korea Times",
        "title": "Samsung Bioepis wins FDA Fast Track for 1st anticancer drug candidate",
        "url": "https://urgent.news/2026/10/21/samsung-bioepis-wins-fda-fast-track-for-1st-anticancer-drug-candidate",
        "published": "2026-10-21T03:12:03.000Z"
      }
    ]
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}