Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has submitted Part 2 (site and execution assessment) of its Phase 3 Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for ‘CT-P44’, a biosimilar candidate to Darzalex.
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Submission of Phase 3 Clinical Trial Plan (Part 2) in Europe for CT-P44 (Darzalex Biosimilar)
- Target Product: CT-P44 (Biosimilar to Darzalex / Darzalex Faspro, Subcutaneous Injection)
- Clinical Trial Phase: Global Phase 3 Clinical Trial
- Target Indication: Refractory or Relapsed Multiple Myeloma
- Filing Date & Regulatory Authority:
- Part 2 Application Date: June 18, 2025 (Local time / Fact Confirmation Date: June 18, 2025)
- Regulatory Authority: European Medicines Agency (EMA) / EU CT Number: 2024-518588-36-00
- Trial Design & Scale:
- Number of Subjects: 486 patients
- Trial Period: Approx. 2 years
- Trial Design: Double-blind, randomized, active-controlled, parallel-group Phase 3 trial (in combination with lenalidomide and dexamethasone)
- Regulatory Context:
- Under the revised EU Clinical Trials Regulation (CTR), Part 2 (site and execution evaluation) was submitted following earlier Part 1 approval
- Full approval of Part 2 is required to officially commence clinical site operations and patient dosing in Europe
- Investment Caution:
- Statistically, the average success rate for clinical-stage drugs reaching final regulatory approval is around 10%
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Final Part 2 Approval for Phase 3 Clinical Trial in Europe
This disclosure details Celltrion’s submission of Part 2 for its Phase 3 clinical trial plan for CT-P44 in Europe following its earlier Part 1 clearance. Following submission, it is key to monitor the European Medicines Agency’s (EMA) review and the secured final approval for Part 2. Securing Part 2 clearance is essential to enable active site initiation and patient recruitment across European trial locations. Regulatory decision updates can be verified through future regulatory filings or upcoming periodic reports (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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