Celltrion's CT-P13 SC Phase 3 Part 1 Approval Expires in Pediatric UC Due to Strategic Shift, Signaling Potential Pipeline Delay
Celltrion disclosed that the Part 1 approval for its global Phase 3 trial of CT-P13 SC subcutaneous formulation in pediatric patients with moderately to severely active ulcerative colitis, granted by the European Medicines Agency EMA, expired on June 18, 2026.
The expiration is due to the company's decision not to submit the Part 2 trial plan following a change in clinical development strategy; under EU Clinical Trial Regulation, Part 1 approval automatically expires if Part 2 is not applied within two years.
While this decision may cause short-term delays in expanding the pediatric indication, the company plans to finalize a new schedule after discussing trial design with regulators, limiting the long-term impact on pipeline value.
[AI Summary]Celltrion's change in clinical strategy for CT-P13 SC in pediatric ulcerative colitis led to the expiration of Part 1 approval. This creates a short-term pipeline delay but does not affect existing adult indications or product revenue; future trial design discussions will determine the impact on shareholder value.
KOSPI Filing Information
Investment Judgment Related Major Management Matters (Expiration Of Approval Of Part 1 Of European Phase 3 Clinical Trial Plan For CTP13 SC (Remsima Subcutaneous Injection Formulation) Due To Development Strategy Change (Pediatric Patients With Ulcerative Colitis))