Celltrion submits Phase 4 clinical trial plan for Zymfentra in the U.S

Celltrion has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 4 clinical trial of its autoimmune disease treatment, Zymfentra (infliximab). The study aims to establish clinical evidence for a high-dose 240mg administration to diversify prescription options in the United States.

The trial will involve 447 patients with Crohn’s disease (CD) and ulcerative colitis (UC) across 55 institutions in the U.S. It seeks to demonstrate the non-inferiority of the 240mg Zymfentra dose compared to high-dose intravenous (IV) infliximab. This strategy follows a successful model used in Europe, where high-dose customized prescriptions helped Remsima SC achieve a 32% market share in five major EU countries during the first quarter of this year.

By establishing a ‘two-track’ prescription system featuring both 120mg and 240mg doses, Celltrion intends to maximize its market presence and cater to varying patient needs. Additionally, the company is pursuing global clinical trials to expand Zymfentra’s indications to include rheumatoid arthritis (RA). Zymfentra reported first-half sales of 99.5 billion KRW, a 176.4% increase compared to the same period last year, supported by over 90% insurance coverage through major U.S. pharmacy benefit managers.