Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that it has submitted an application for the Phase 3 clinical trial plan (Part 1 & 2) of CT-P55, a biosimilar to the plaque psoriasis treatment Cosentyx, to the European Medicines Agency (EMA).
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Application for Phase 3 Clinical Trial Plan for CT-P55 (Cosentyx Biosimilar) in Europe (Part 1 & 2)
- Application Date: October 11, 2024 (Local time)
- Regulatory Authority: European Medicines Agency (EMA)
- Board Resolution or Fact Confirmation Date: October 11, 2024
- Clinical Trial Details
- Trial Phase: Global Phase 3 Clinical Trial
- Indication: Plaque psoriasis
- Clinical Trial Registration Number: EU CT number 2024-513348-27-00
- Objective: To demonstrate biosimilarity by comparing the efficacy and safety between CT-P55 and the original drug Cosentyx
- Number of Subjects: 375 patients
- Trial Duration: 56 weeks
- Study Design: Randomized, active-controlled, double-blind
- Additional Information & Investment Risk Warnings
- Submitted under the revised European Clinical Trials Regulation (effective January 31, 2023), which splits the process into Part 1 (evaluation of trial design and methodology) and Part 2 (evaluation of trial sites and implementation). Final approval through Part 2 is required to initiate the trial. This filing covers the simultaneous submission of Part 1 and Part 2.
- Statistically, the probability of a clinical-stage drug candidate receiving final market authorization is known to be around 10%, and commercialization plans may be modified or abandoned depending on trial results.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Final Approval Status by the European Medicines Agency (EMA)
This disclosure reports the initial application stage for Phase 3 clinical trial approval (Part 1 & 2) in Europe. Tracking whether final approval is granted by the EMA after regulatory review is important for determining the actual initiation and progress of the clinical trial. Detailed progress can be verified in subsequent regulatory disclosures and upcoming periodic reports (Quarterly, Half-Yearly, or Annual Reports).
📢 Disclaimer & Source Notice
Source: This content has been newly structured and created based on official submission data from the Financial Supervisory Service’s Data Analysis, Retrieval and Transfer System (DART).
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