[Disclosure] Celltrion (068270) Obtains Final Approval for U.S. Blockbuster ‘Darzalex’ Biosimilar ‘CT-P44’ Phase 3 Clinical Trial in Europe (Part 2 Cleared)

Source: Financial Supervisory Service (DART) / 2025-09-01

Disclosure Type: Matters of Major Management Decisions Related to Investment Judgment

💡 3-Second Summary

Celltrion has secured Part 2 (clinical site and operational assessment) approval from the European Medicines Agency (EMA) for the Phase 3 clinical trial of ‘CT-P44’, a biosimilar of the multiple myeloma blockbuster Darzalex, completing all administrative procedures to begin patient dosing in Europe.

📊 1. [Key Disclosure Details and Major Financial Figures Summary]

• Clinical Trial Phase: Global Phase 3 Clinical Trial
• Investigational Drug & Reference Product: CT-P44 (Reference Product: Darzalex Faspro – Subcutaneous Injection)
• Target Indication: Refractory or Relapsed Multiple Myeloma
• Trial Design and Scale:
  • Total Number of Subjects: 486 patients
  • Trial Period: Approximately 2 years
  • Design Details: Double-blind, randomized, active-controlled, parallel-group study comparing efficacy and safety in combination with lenalidomide and dexamethasone.
• Approval Timeline (Europe) & Regulatory Body:
  • Regulatory Authority: European Medicines Agency (EMA)
  • Part 2 Submission Date: June 18, 2025 (Local Time)
  • Part 2 Approval Date: August 29, 2025 (Local Time)
  • Clinical Trial Registration Number: EU CT number: 2024-518588-36-00
• Regulatory Context: Under revised European clinical trial regulations, approvals are divided into Part 1 (assessment of clinical trial design and methodology) and Part 2 (assessment of trial sites and local conduct). Following the Part 1 clearance in April 2025, Celltrion has now secured Part 2 approval, fulfilling all regulatory requirements to commence patient recruitment.

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

• Fundamental Impact & Market Scale: Securing Phase 3 clinical trial approval allows Celltrion to officially begin demonstrating the biosimilarity of CT-P44 to Darzalex, a multi-billion dollar blockbusting cancer treatment. Success in this trial could significantly strengthen Celltrion’s long-term oncology portfolio and diversify its future revenue stream in the lucrative European market.
• Inherent Clinical Risks: Despite entering Phase 3, investors must remain aware of the high attrition rates in pharmaceutical development. Statistically, the probability of an investigational drug successfully navigating clinical trials to secure final marketing authorization is approximately 10%. Efficacy or safety hurdles during the next two years of trials may result in regulatory delays, protocol amendments, or termination of the program.
• Delayed Earnings Materialization: This disclosure represents an administrative milestone allowing the initiation of clinical testing, not commercial product launch. Given that the trial is estimated to take at least two years—followed by regulatory review and marketing approval processes—any material contribution to Celltrion’s consolidated revenue will likely experience a multi-year lag.

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

Celltrion has cleared the administrative hurdles of Europe’s split regulatory framework (Part 1 and Part 2), officially starting the clock on the global Phase 3 trial for CT-P44. While target market size makes this a highly anticipated asset, smart investors should focus on the execution of the actual clinical trial. Patient enrollment and comparative dosing across 486 subjects will take up to two years. Demonstrating precise biosimilarity in therapeutic efficacy and safety compared to Darzalex Faspro is a complex task. Watching the progress of this trial with patience and a focus on interim data milestones is the most rational way to gauge its long-term corporate value.

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