Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that it has submitted an application for a Phase 3 clinical trial plan to the Ministry of Food and Drug Safety (MFDS) of South Korea to evaluate the efficacy and safety of CT-P13 SC in pediatric patients with ulcerative colitis.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Application for Phase 3 Clinical Trial Plan for CT-P13 SC (Remsima Subcutaneous Formulation) in South Korea (Pediatric Patients with Ulcerative Colitis)
- Application Date: September 30, 2024
- Regulatory Authority: Ministry of Food and Drug Safety (MFDS), South Korea
- Board Resolution or Fact Confirmation Date: September 30, 2024
- Clinical Trial Details
- Trial Phase: Phase 3 Clinical Trial
- Indication: Moderately to Severely Active Ulcerative Colitis in Pediatric Patients (Ages 6–17)
- Clinical Trial Registration Number: EU CT number 2024-511605-31
- Objective: To evaluate and compare the efficacy of CT-P13 SC low-dose and high-dose biweekly maintenance therapy in achieving clinical remission at Week 54
- Number of Subjects: 243 patients
- Trial Duration: Treatment period of 106 weeks
- Study Design: Randomized, double-blind
- Future Plans & Investment Risk Warnings
- CT-P13 SC previously completed Phase 3 trials in adult patients with ulcerative colitis and Crohn’s disease, earning approvals in major markets including the U.S. and Europe. This trial aims to expand treatment options to pediatric patients.
- 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 outcomes.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Approval Status of Clinical Trial Plan by the Ministry of Food and Drug Safety (MFDS)
This disclosure reports the initial application stage for Phase 3 clinical trial approval in South Korea for pediatric ulcerative colitis patients. Tracking whether final approval of the clinical trial plan is granted by regulatory authorities after review is important for determining the actual initiation of patient dosing and trial execution. 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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