Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that it has submitted an application for a global Phase 3 clinical trial plan to the U.S. Food and Drug Administration (FDA) to evaluate the efficacy and safety of CT-P51 compared with Keytruda in patients with non-small cell lung cancer.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Application for Phase 3 Clinical Trial Plan for CT-P51 (Keytruda Biosimilar) in the U.S.
- Application Date: June 14, 2024 (Local Time)
- Regulatory Authority: U.S. Food and Drug Administration (FDA)
- Board Resolution or Fact Confirmation Date: June 14, 2024 (Date of submitting the clinical trial application to the U.S. FDA)
- Clinical Trial Details
- Trial Phase: Global Phase 3 Clinical Trial
- Indication: Non-Small Cell Lung Cancer (NSCLC)
- Clinical Trial Registration Number: EU CT number 2024-514048-98-00
- Objective: To compare efficacy and safety between CT-P51 and Keytruda to demonstrate biosimilarity
- Number of Subjects: 606 patients in total
- Trial Duration: Treatment period of 2 years
- Study Design: Double-blind, randomized, active-controlled, Phase 3 clinical trial
- Future Plans & Important Notes
- Celltrion aims to demonstrate biosimilarity to the reference drug Keytruda through this Phase 3 trial and seek authorization across all approved indications of the original drug.
- 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 U.S. FDA
This disclosure reports the initial application stage for Phase 3 clinical trial approval in the U.S. for CT-P51 (Keytruda biosimilar). Tracking whether final approval of the clinical trial plan is granted by regulatory authorities after review is important for assessing the actual progress of the pipeline development. Detailed updates can be verified in subsequent 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).
Investment Risk Warning: This content is provided for informational and linguistic reference purposes only. Under no circumstances does it constitute financial advice or a recommendation to buy or sell specific stocks. All investment decisions and financial responsibilities rest solely with the investor.
Contact: For compliance inquiries or copyright requests, please contact ksb220805@gmail.com.
