Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion received approval from the Ministry of Food and Drug Safety (MFDS) of South Korea for its Phase 3 Clinical Trial Application (IND) of CT-P13 SC (Remsima Subcutaneous) in pediatric patients with moderately to severely active ulcerative colitis.
📊 Key Disclosure Content & Financial Highlights
- Overview
- Company: Celltrion, Inc. (Stock Code: 068270)
- Disclosure Type: Major Matters Report Related to Investment Decisions
- Subject: Approval of Phase 3 Clinical Trial Application for CT-P13 SC (Remsima Subcutaneous) in Pediatric Ulcerative Colitis in South Korea
- Regulatory Authority: Ministry of Food and Drug Safety (MFDS), South Korea
- Application & Approval Dates: Application Date 2024-09-30 / Approval Date 2025-02-21
- Confirmation Date: 2025-02-21 (Date official approval document was confirmed)
- Clinical Trial Details
- Study Title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of CT-P13 Subcutaneous (CT-P13 SC) as Maintenance Therapy in Pediatric Patients with Moderately to Severely Active Ulcerative Colitis
- Phase: Phase 3
- Target Indication: Pediatric Patients (aged 6–17) with Moderately to Severely Active Ulcerative Colitis
- Registration Number: EU CT number 2024-511605-31
- Patient Count: 243 subjects
- Duration: 106-week treatment period
- Purpose: To compare and evaluate the efficacy of low-dose versus high-dose CT-P13 SC maintenance therapy administered every 2 weeks in achieving clinical remission at Week 54
- Key Features & Investment Risks
- CT-P13 SC is the subcutaneous formulation of infliximab biosimilar Remsima IV, designed to increase patient convenience.
- Having completed Phase 3 trials and secured approvals for adult ulcerative colitis and Crohn’s disease in major markets (US, Europe), this trial aims to expand patient coverage to pediatric populations.
- Statistically, the probability of a clinical-stage drug candidate receiving final approval is approximately 10%. Commercialization plans may change or be abandoned depending on trial outcomes.
- Content of this disclosure will be utilized in future press releases and IR materials.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Monitoring Clinical Trial Progress and Patient Recruitment in Pediatric Population
This disclosure serves as official notification regarding the approval of a Phase 3 clinical trial in South Korea to expand the indication of Remsima SC (CT-P13 SC) to pediatric ulcerative colitis patients. Tracking patient recruitment and the smooth execution of trial milestones is important for assessing the progress of indication expansion for this key product. Relevant updates can be confirmed through subsequent periodic reports or official IR announcements.
📢 Disclaimer & Source Notice
Source: This content was structured and generated based on official disclosure data from the Financial Supervisory Service’s DART system.
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