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Product image of Zymfentra. / Courtesy of Celltrion

Celltrion is pursuing a Phase 3 clinical trial to expand the therapeutic indications of Zymfentra, its autoimmune disease treatment, to include rheumatoid arthritis.

Celltrion announced in a public filing on the 23rd that its global Phase 3 clinical trial plan for Zymfentra has been approved for patients with moderately to severely active rheumatoid arthritis. A total of 296 patients will participate in the trial. The study will evaluate efficacy and safety by comparing the Zymfentra-administered group with a placebo group over a 52-week treatment period.

The primary endpoint is the proportion of patients achieving ACR50 at week 12 of treatment. ACR50 is a benchmark used to determine whether rheumatoid arthritis symptoms have improved by at least 50%, based on comprehensive evaluations including the number of tender and swollen joints as well as overall patient condition. Through this endpoint, Celltrion plans to verify whether Zymfentra demonstrates superior therapeutic efficacy compared to the placebo.

Zymfentra is a subcutaneous formulation of Remsima, an infliximab biosimilar. It differs in administration route from Remsima, which is given intravenously. Celltrion developed the subcutaneous formulation to enhance patient convenience.

Zymfentra previously received regulatory approvals in jurisdictions including the U.S. and Europe following Phase 3 clinical trials in adult patients with ulcerative colitis and Crohn's disease. Based on the outcomes of this clinical trial, Celltrion plans to pursue an indication expansion for Zymfentra to cover rheumatoid arthritis.

The U.S. Food and Drug Administration (FDA) did not issue a separate notification of approval for the trial plan. In line with relevant FDA procedures, Celltrion disclosed September 23—60 days after the filing date of July 24—as the approval date upon the expiration of the review period.

                                                                                                             Bae Da-hyun