Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has disclosed the previously withheld information regarding the number of trial subjects (220 patients) for its CT-P51 Phase 3 IND amendment in Korea following regulatory approval.
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Application for Amendment of Phase 3 Clinical Trial Plan for CT-P51 (Keytruda Biosimilar) in Korea (Correction)
- Original Disclosure Date: March 30, 2026 (Correction Filing Date: April 24, 2026)
- Reason for Correction: Lifting of disclosure withholding upon approval of the Phase 3 IND amendment
- Key Corrected Details:
- Number of Clinical Trial Subjects: (Before) Undisclosed → (After) 220 patients
- Withholding Removal Details: The item previously withheld for business confidentiality (number of subjects) was made public as the withholding period expired upon IND amendment approval.
- Trial Application Details (Filed March 30, 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
- Trial Registration Number: EU CT number 2024-514048-98-00
- Trial Scale & Duration: 220 patients / 2-year treatment period
- 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 Disclosed Metrics and Future Clinical Progress Reports
This corrected disclosure reveals the previously confidential trial subject count (220 patients) for the CT-P51 Phase 3 IND amendment application following regulatory approval by MFDS, making it important to monitor upcoming progress reports. Tracking clinical execution under the newly disclosed parameters ensures complete visibility into trial status following regulatory authorization. Clinical trial execution updates 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
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.
Investment Risk Notice: This information is provided for informational and linguistic reference purposes only. Under no circumstances does it constitute financial advice or a recommendation to buy or sell any specific stock. All investment decisions and financial responsibilities rest solely with the investor.
Contact: For compliance inquiries or copyright concerns, please contact ksb220805@gmail.com.
