{
  "id": 7444624,
  "title": "Celltrion Moves to Expand Zymfentra Use in the U.S. With New Phase 4 Trial",
  "url": "https://urgent.news/2026/09/15/celltrion-moves-to-expand-zymfentra-use-in-the-u-s-with-new-phase-4",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-09-15T02:06:06.000Z",
  "source": {
    "name": "Korea IT Times",
    "slug": "korea-it-times",
    "url": "https://www.koreaittimes.com/news/articleView.html?idxno=157163"
  },
  "original_language": "en",
  "account": "Celltrion is intensifying efforts to broaden the use of Zymfentra in the United States through a new Phase 4 trial. The South Korean company submitted an Investigational New Drug (IND) application to the FDA for a study examining a 240mg dose of Zymfentra, a subcutaneous formulation, compared to high-dose intravenous infliximab. The trial will involve 447 patients with Crohn's disease or ulcerative colitis across 55 U.S. medical centers, focusing on establishing clinical evidence for non-inferiority of the higher dose. If successful, Zymfentra could offer U.S. physicians a two-dose treatment approach, complementing the existing 120mg regimen. This strategy echoes Celltrion's approach with Remsima SC in Europe, which recorded a 32% market share in the first quarter of the year. Expanding dosing options is part of Celltrion's broader growth strategy, including pursuing additional clinical development for rheumatoid arthritis (RA) to widen Zymfentra's potential patient base. Zymfentra has already seen strong commercial growth in the U.S., generating 99.5 billion won ($72 million) in sales during the first half of the year and securing reimbursement coverage for over 90% of insured patients. Industry analysts suggest that factors beyond clinical efficacy, such as reimbursement access, prescribing convenience, and differentiated dosing options, are increasingly influencing a product's market penetration in the U.S. biologics market. Celltrion aims to leverage these expanded dosing options, potential new indications, and its direct-sales infrastructure to enhance Zymfentra's position in the American autoimmune disease market.",
  "summary": "Celltrion is accelerating clinical development of Zymfentra in the United States as it seeks to expand the drug’s prescribing options beyond its current 120mg dose.The South Korean biopharmaceutical company said Tuesday that it has submitted an Investigational New Drug (IND) application to the U.S.",
  "key_points": [
    "Celltrion initiates Phase 4 trial for Zymfentra in U.S., testing 240mg dose.",
    "447 patients with Crohn's disease or ulcerative colitis to participate across 55 centers.",
    "Successful trial could provide U.S. doctors two-dose treatment option for autoimmune diseases."
  ],
  "editors_take": "Celltrion's new Phase 4 trial for Zymfentra in the US aims to establish a two-dose treatment approach, potentially broadening the drug's appeal and market share among US physicians and patients.",
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "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."
}