Celltrion announced on the 18th that, following a change in its development strategy, the approval for the Phase 3 clinical trial plan (Part 1) for pediatric ulcerative colitis involving 'CT-P13 SC (subcutaneous formulation of Remsima)' conducted in Europe has expired.

The clinical trial was a global Phase 3 study aimed at evaluating the efficacy and safety of CT-P13 SC in pediatric patients (aged 6 to 17) suffering from moderate to severe active ulcerative colitis.

Following the change in its clinical development strategy, Celltrion decided not to submit an application for the subsequent Part 2 trial plan. Under the European Clinical Trial Regulation (EU CTR), if the Part 2 trial plan is not submitted within two years of Part 1 approval, the Part 1 approval automatically expires.

Looking at the specific timeline, the clinical trial plan was submitted to the European Medicines Agency (EMA) on February 27, 2024, and was approved on June 17 of the same year. The approval expiration date is June 18, 2026.

The company explained, "This expiration is a procedural matter in accordance with European clinical trial regulations, and the date of confirmation also marks the point at which two years have elapsed since the Part 1 approval date." Celltrion plans to finalize a specific follow-up schedule after discussions with regulatory authorities regarding the clinical trial design.