Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has confirmed approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for an IND amendment application regarding the Phase 3 clinical trial of CT-P51 (a Keytruda biosimilar candidate).
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Approval of Application for Amendment of Phase 3 Clinical Trial Plan for CT-P51 (Keytruda Biosimilar) in Korea
- Filing Date & Approval Date: Filing Date March 30, 2026 / Approval Date April 23, 2026
- Regulatory Agency: Ministry of Food and Drug Safety (MFDS)
- Clinical Trial Phase: Global Phase 3
- Target Indication: Metastatic Non-Squamous Non-Small Cell Lung Cancer
- Clinical Trial Title: A randomized, double-blind, active-controlled, parallel-group Phase 3 study to compare the efficacy and safety of CT-P51 versus Keytruda in combination with platinum-pemetrexed chemotherapy in previously untreated patients with metastatic non-squamous non-small cell lung cancer
- Trial Registration Number: EU CT number 2024-514048-98-00
- Trial Scale & Duration: 220 patients / 2-year treatment period
- Trial Design: Double-blind, randomized, active-controlled, Phase 3 clinical trial
- Board Resolution / Fact Confirmation Date: April 24, 2026 (Date of confirming approval of IND amendment from MFDS)
- Investment Caution: Statistically, the final approval rate for clinical drug candidates is approximately 10%. Unforeseen results during trial or approval stages may lead to changes or cancellation of commercialization plans.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Phase 3 Clinical Trial Execution via Subsequent Regulatory Reports
This disclosure details Celltrion’s confirmation of MFDS approval for the amended Phase 3 clinical trial plan for CT-P51, making it important to monitor upcoming regulatory filings for trial execution. Tracking official progress updates ensures that trial activities align with the updated protocol following regulatory authorization. Updates regarding clinical trial progress can be tracked through upcoming periodic filings (Quarterly, Half-Yearly, or Annual Business Reports) under the ‘Ongoing Research and Development Activities’ section or through future regulatory disclosures.
📢 Disclaimer & Source Information
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