Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has submitted an application for Part 1 & Part 2 of a Phase 3 clinical trial protocol amendment to the European Medicines Agency (EMA) for CT-P44, a biosimilar to Darzalex (a treatment for multiple myeloma). The amendment involves adjusting the number of clinical trial participants due to a shift in regulatory approval strategy.
📊 [Summary of Key Disclosure Content & Major Figures]
- Regulatory Authority: European Medicines Agency (EMA)
- Application Date: July 13, 2026 (Local Time)
[Clinical Trial Details]
- Trial Title: A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Clinical Trial to Compare the Efficacy and Safety of Subcutaneous CT-P44 Versus Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma
- Development Phase: Global Phase 3 Clinical Trial
- Target Indication: Refractory or Relapsed Multiple Myeloma
- Registration Number: EU CT number: 2024-518588-36-00
- Study Objective: To demonstrate biosimilarity by comparing the efficacy and safety between CT-P44 and the original drug, Darzalex
[Study Design & Amendment Details]
- Total Subjects: 394 patients
- Study Duration: 2 years
- Study Design: Double-blind, randomized, active-controlled, parallel-group Phase 3 clinical trial
- Reason for Amendment: Adjustment of subject count following a change in regulatory approval strategy
- Regulatory Note: Pursuant to revised EU clinical trial regulations, Part 1 (trial design and methodology evaluation) and Part 2 (clinical site and execution evaluation) amendments were submitted simultaneously. Approval through Part 2 is required for the trial to proceed.
[Related Prior Filings]
- 2024-11-28: Application for Phase 3 Clinical Trial Plan (Part 1) of CT-P44 (Darzalex Biosimilar) in Europe
- 2025-04-01: Clearance of Phase 3 Clinical Trial Plan (Part 1) of CT-P44 (Darzalex Biosimilar) in Europe
- 2025-06-19: Application for Phase 3 Clinical Trial Plan (Part 2) of CT-P44 (Darzalex Biosimilar) in Europe
- 2025-09-01: Approval of Phase 3 Clinical Trial Plan (Part 2) of CT-P44 (Darzalex Biosimilar) in Europe
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 European Medicines Agency (EMA) Approval Status of Amended Phase 3 Protocol (Part 1 & 2) and Finalized Clinical Parameters
This disclosure pertains to an application submitted to the EMA for a Phase 3 clinical trial protocol amendment (Part 1 & Part 2) following a change in regulatory approval strategy. Checking whether regulatory authorities grant final approval and how the adjusted trial parameters are confirmed is essential for understanding the progress of the trial and how the revised strategy is implemented. Relevant updates can be verified in future regulatory disclosures, annual business reports, or quarterly and half-yearly reports.
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