[Disclosure] Celltrion (068270) Submits Phase 3 Clinical Trial Application (IND) for ‘Keytruda Biosimilar (CT-P51)’ to South Korean MFDS

Source Facts: Financial Supervisory Service Electronic Disclosure System (DART) / 2025-01-15

Disclosure Type: Major Management Matters Related to Investment Decisions

💡 3-Second Summary

Celltrion has submitted a Phase 3 clinical trial application to the South Korean Ministry of Food and Drug Safety (MFDS) for ‘CT-P51’, a biosimilar to the immunotherapy ‘Keytruda’, to evaluate its efficacy and safety compared to the reference drug in 606 patients.

📊 1. [Key Disclosure Content & Key Metrics Summary]

• Target Pipeline: CT-P51 (Keytruda biosimilar, reference product: Keytruda).
• Target Indication: Metastatic Non-Squamous Non-Small Cell Lung Cancer.
• Trial Phase & Objective: Global Phase 3 clinical trial designed to compare the efficacy and safety of CT-P51 and Keytruda in combination with platinum-pemetrexed chemotherapy in previously untreated patients with metastatic non-squamous non-small cell lung cancer, aiming to demonstrate biosimilarity.
• Trial Design Details:
  • Total Enrolled Patients: 606 subjects
  • Trial Duration: 2 years of treatment period
  • Study Design: Double-blind, randomized, active-controlled, parallel-group, Phase 3 study.
• Application Details:
  • Application Date: January 15, 2025
  • Regulatory Body: South Korean Ministry of Food and Drug Safety (MFDS)
  • Clinical Trial Registry Number: EU CT number: 2024-514048-98-00
• Future Plans: Celltrion intends to demonstrate biosimilarity through this study. It expects to expand its market presence and increase revenue by seeking marketing authorization for all indications approved for the reference product, including other types of non-small cell lung cancer.

📈 2. [Expert View: What This Disclosure Means for Investors]

• Initiation of Administrative Steps for Phase 3 Trial: This filing represents the initial administrative step of submitting the trial protocol to the MFDS to conduct the Phase 3 study in South Korea. Celltrion must wait for the regulatory body’s official review and approval of the protocol before initiating actual patient dosing and trials.
• Stated Commercial Goal for Indication Expansion: The disclosure highlights Celltrion’s long-term commercial intent to seek marketing authorization for all indications approved for the reference product. This objective remains dependent on the successful completion of the clinical trial and subsequent regulatory approvals.
• Consideration of Trial Timelines and Statistical Probabilities: As noted in the cautionary statement, the statistical probability of a clinical-stage therapeutic securing final regulatory approval is approximately 10%. With a designated treatment period of two years, investors should monitor the progress as a long-term project with a corresponding timeline for data generation.

📝 Editor’s Comment (by K-STOCK Editor)

This disclosure marks the formal entry of CT-P51 into the regulatory review pipeline in South Korea with the submission of the Phase 3 clinical trial protocol to the MFDS. Following the acquisition of the European registration number (EU CT number), this filing serves as an administrative step toward preparing the multi-country trial infrastructure.

The immediate parameter for market participants to track is the official approval of the clinical trial application (IND) by the MFDS. Because this filing is an application rather than an approval, final clearance from the regulatory authority is required before the company can proceed with patient enrollment and initiate the two-year treatment regimen.

Going forward, key parameters to observe include the timeline for the MFDS’s final protocol approval, the pace of patient enrollment across trial sites, and any regulatory updates regarding the clinical development plan published through subsequent corporate filings.

📢 Disclaimer & Source Information

Source: This content has been newly structured and written based on official disclosure data submitted to the Financial Supervisory Service’s Electronic Disclosure System (DART).

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