Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has disclosed the previously withheld subject count (153 patients) for the Phase 3 clinical trial plan amendment application for CT-P55 (Cosentyx biosimilar candidate) in Europe through a corrective filing following regulatory approval.
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Application for Amendment of Phase 3 Clinical Trial Plan for CT-P55 (Cosentyx Biosimilar) in Europe (Part 1 & 2) (Correction)
- Original Filing & Correction Date: October 27, 2025 / February 10, 2026
- Reason for Correction: Expiration of non-disclosure period upon approval of Part 1 & Part 2 amendments
- Key Corrected Information:
- Number of Trial Subjects: (Before) Undisclosed → (After) 153 patients
- Clinical Trial Summary:
- Target Indication: Plaque psoriasis
- Application Date & Regulatory Agency: October 27, 2025 (Local time) / European Medicines Agency (EMA)
- Trial Registration Number: EU CT number 2024-513348-27-00
- Duration & Design: 56 weeks / Randomized, active-controlled, double-blind, Phase 3 study
- Reason for Amendment: Adjustment of sample size following shifts in regulatory approval strategy
- Board Resolution / Fact Confirmation Date: October 27, 2025 (Date of submission to EMA)
- Investment Caution: Statistically, the final approval rate for clinical drug candidates is approximately 10%. Unforeseen results during trial stages may lead to changes or cancellation of commercialization plans.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Finalized Subject Count and Subsequent Clinical Progress
This corrected disclosure reveals the previously withheld sample size (153 patients) following the approval of Part 1 and Part 2 amendments for CT-P55. With the updated trial plan approved by European regulators, it is important to monitor patient enrollment and trial execution over the 56-week duration. Detailed progress, safety/efficacy evaluation, and future regulatory submission plans can be verified through subsequent disclosures or upcoming periodic filings (Quarterly, Half-Yearly, or Annual Business Reports).
📢 Disclaimer & Source Information
Source: This content was newly generated and structured based on official data submitted to the Data Analysis, Retrieval and Transfer System (DART) of the Financial Supervisory Service.
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