Celltrion Advances High-Dose Clinical Trial for "Zymfentra" to Broaden U.S. Prescription Base

IND Application Submitted for U.S. Phase IV Clinical Trial of 240mg Dose
Full-scale Implementation of Patient-Customized Two-Track Prescription System

Celltrion has officially commenced the procedure to secure evidence for high-dose administration of "Zymfentra," the U.S. product name for Remsima SC. The goal is to broaden the base of prescriptions for Zymfentra in the U.S. autoimmune disease market and further differentiate the product's competitiveness.

Celltrion 'Remsima SC' product image. Celltrion

On September 15, Celltrion announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase IV clinical trial targeting the high-dose 240mg administration of Zymfentra (ingredient: infliximab) in the United States.

This clinical trial will be conducted at 55 medical institutions across the United States and will enroll a total of 447 patients with Crohn’s disease (CD) and ulcerative colitis (UC). Specifically, the trial plans to verify the non-inferiority of the high-dose infliximab intravenous (IV) formulation versus Zymfentra 240mg, thereby establishing objective clinical data necessary for the future high-dose administration of Zymfentra.

Through this trial, Celltrion expects to broaden dosing options and offer optimal therapeutic alternatives tailored to patients’ conditions and disease severity. In the U.S. as well, the company plans to solidify a patient-customized "two-track" prescription system utilizing both 120mg and 240mg dosing options.

Celltrion is also working in parallel to expand the indications of Zymfentra in order to enlarge its potential market size. The company is currently proceeding with global clinical procedures to add rheumatoid arthritis (RA) as an indication for Zymfentra. RA is a major indication with a large patient population in the U.S. and accounts for a significant portion of the overall autoimmune disease market. If the RA indication is added, the base of Zymfentra's prescriptions will expand beyond inflammatory bowel disease (IBD) to the entire U.S. autoimmune disease therapeutic market.

Currently, Zymfentra has successfully established a presence in the U.S. market. By working closely with pharmacy benefit management companies (PBMs) in the U.S., Celltrion has secured insurance reimbursement coverage for more than 90% of patients. This, combined with the local affiliate’s direct sales network and intensive marketing capabilities, is generating strong synergy.

A Celltrion official stated, "This clinical trial will serve as an important milestone, further elevating the clinical value of Zymfentra by diversifying personalized treatment options according to patient status. We will concentrate all our organizational capabilities to establish Zymfentra as a leading treatment in the U.S. autoimmune disease market by leveraging robust clinical data, differentiated product competitiveness, and advanced direct sales capabilities."

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