Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has received final approval from the European Medicines Agency (EMA) for the amendment of the Phase 3 clinical trial plan (Part 1 & Part 2) for CT-P55 (Cosentyx biosimilar candidate).
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Approval for Amendment of Phase 3 Clinical Trial Plan for CT-P55 (Cosentyx Biosimilar) in Europe (Part 1 & 2)
- Filing Date, Approval Date & Regulatory Agency:
- Application Date: October 27, 2025 (Local time)
- Approval Date: February 9, 2026 (Local time)
- Regulatory Agency: European Medicines Agency (EMA)
- Clinical Trial Phase: Global Phase 3
- Target Indication: Plaque psoriasis
- Clinical Trial Title: A randomized, active-controlled, double-blind, Phase 3 study to compare the efficacy and safety of CT-P55 and Cosentyx in patients with moderate to severe plaque psoriasis
- Trial Registration Number: EU CT number 2024-513348-27-00
- Trial Design & Duration:
- Number of Subjects: 153 patients
- Duration: 56 weeks
- Design: Randomized, active-controlled, double-blind, Phase 3 study
- Key Note: Final concurrent approval received for both Part 1 (trial design/methodology) and Part 2 (trial site/execution) under updated EU regulations
- Board Resolution / Fact Confirmation Date: February 10, 2026 (Date of confirmation via CTIS)
- Investment Caution: Statistically, the final approval rate for clinical drug candidates is approximately 10%. Unforeseen results during trial or approval stages may lead to changes or cancellation of commercialization plans.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of European Phase 3 Clinical Trial Execution and Results
This disclosure details the approval from the EMA for Celltrion’s amendment of the Phase 3 clinical trial plan (Part 1 & Part 2) for CT-P55, making it important to monitor the execution of patient dosing and trial progress over the 56-week duration. Tracking subsequent trial developments following regulatory approval ensures verification of project milestones. Efficacy, safety results, and ongoing clinical progress can be verified through future regulatory disclosures or upcoming periodic filings (Quarterly, Half-Yearly, or Annual Business Reports).
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