[Disclosure] Celltrion (068270) Submits Application to U.S. FDA to Amend Phase 3 Clinical Trial Plan for Cosentyx Biosimilar ‘CT-P55’

Fact Source: Financial Supervisory Service DART / 2026-03-12

Disclosure Type: Major Management Matters Related to Investment Judgment

💡 3-Second Summary

Celltrion has submitted an application to the U.S. Food and Drug Administration (FDA) to modify its global Phase 3 clinical trial plan for ‘CT-P55’, a biosimilar targeting the plaque psoriasis treatment ‘Cosentyx’.

📊 1. [Summary of Key Disclosure Content and Major Figures]

• Submission Date: March 12, 2026 (Local time basis)
• Application Authority: U.S. Food and Drug Administration (FDA)
• Trial Title: A Randomized, Active-Controlled, Double-Blind, Phase 3 Clinical Trial to Compare the Efficacy and Safety of CT-P55 and Cosentyx in Patients with Moderate to Severe Plaque Psoriasis
• Clinical Trial Phase: Global Phase 3 Clinical Trial
• Target Disease (Indication): Plaque psoriasis
• Clinical Trial Registration Number: EU CT number: 2024-513348-27-00
• Trial Objective: To compare the efficacy and safety between CT-P55 and Cosentyx
• Trial Design and Scale:
  • Number of Subjects: 153 patients
  • Trial Duration: 56 weeks
  • Study Design: Randomized, active-controlled, double-blind, Phase 3 clinical trial

[Important Cautions & Future Plans]

• Statistically, the probability of a clinical trial drug receiving final regulatory approval as a medicine is known to be around 10%.
• Unexpected outcomes may occur during clinical trials and approval processes, which may lead the company to alter or abandon its commercialization plans.
• This disclosure content is scheduled to be utilized in future press releases and IR materials.

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

This disclosure represents a procedural adjustment within the development timeline of Celltrion’s next-generation biosimilar pipeline, ‘CT-P55’. It conveys the factual event that the company has applied to the U.S. FDA for modifications to its Phase 3 study protocol, which aims to evaluate biosimilarity in terms of efficacy and safety relative to the original reference product, Cosentyx.

For investors, this signals that the Phase 3 global trial is progressing through necessary regulatory fine-tuning rather than facing a complete halt. However, as explicitly cautioned in the disclosure, the statistical probability of any investigational drug transitioning from clinical trials to final marketing authorization is approximately 10%. Consequently, potential impacts such as underperforming data or adjustments to the launch timeline could occur. Because the specific reasons for the protocol modifications were not detailed in this report, investors could prudently track the U.S. FDA’s subsequent approval of these changes alongside future periodic updates.

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

Celltrion’s CT-P55 pipeline has entered a regulatory stage with this modification request for its U.S. Phase 3 trial. While the disclosure does not specify the reasons for the protocol modifications, the inherent low success rate of biopharmaceutical commercialization—statistically around 10%—demands analytical caution. Market participants is likely to monitor when the U.S. FDA grants formal clearance for this modified plan and how smoothly the 56-week trial unfolds across the 153 enrolled subjects over the medium term.

📢 Disclaimer and Source Information

Source: This content was newly structured and written based on official data submitted to the Financial Supervisory Service’s electronic disclosure system (DART).

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