Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion’s Part 1 approval for the European Phase 3 trial of CT-P13 SC in pediatric Crohn’s disease has expired under EU CTR regulations as the company opted not to submit a Part 2 application due to a change in development strategy.
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Expiration of Part 1 Approval for Phase 3 Clinical Trial Plan of CT-P13 SC (Remsima Subcutaneous) in Europe Due to Development Strategy Change (Pediatric Crohn’s Disease)
- Target Indication: Moderately to Severely Active Pediatric Crohn’s Disease (Ages 6–17)
- Clinical Trial Phase: Global Phase 3
- Dates & Regulatory Agency:
- Filing Date: February 27, 2024 (Local Time)
- Approval Date: June 17, 2024 (Local Time)
- Expiration Date: June 18, 2026 (Local Time)
- Agency: European Medicines Agency (EMA)
- Reason for Expiration: Decision made not to submit the Part 2 application following a shift in clinical development strategy. Under the EU Clinical Trials Regulation (EU CTR), Part 1 approval automatically expires if Part 2 is not filed within 2 years of Part 1 approval.
- Future Plans: Re-evaluate and finalize the clinical trial design following discussions with regulatory authorities before resuming the study.
- Board Resolution / Fact Confirmation Date: June 18, 2026 (Date marking 2 years from Part 1 approval)
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Monitoring Regulatory Discussions and Resubmission of Revised Phase 3 Trial Protocol
This disclosure marks an administrative expiration of the existing Part 1 approval, making it vital to track whether Celltrion submits a modified Phase 3 protocol following discussions with regulatory bodies. Tracking future disclosures regarding revised trial filings and approvals will be essential to understanding the updated timeline and scope for expanding Remsima SC’s indication into pediatric Crohn’s disease. Progress and updates can be verified in subsequent regulatory filings or under the ‘Ongoing Research and Development Activities’ section in 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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