[Disclosure] Celltrion (068270) – CT-P55 (Cosentyx Biosimilar) Korea Marketing Authorization Application / 2026-06-26

Fact Source: Financial Supervisory Service DART

💡 3-Second Summary

Celltrion has submitted an application for marketing authorization of CT-P55, a biosimilar candidate referencing Cosentyx, to the Ministry of Food and Drug Safety (MFDS) in South Korea.

📊 [Key Disclosure Details & Financial Summary]

• Disclosure Title: Application for Marketing Authorization of CT-P55 (Cosentyx Biosimilar) in South Korea
• Filing Date & Agency: June 26, 2026, Ministry of Food and Drug Safety (MFDS)
• Product & Active Ingredient: Cosentyx Biosimilar CT-P55 (Secukinumab)
• Target Indications: Adult Plaque Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis (Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis)
• Clinical Trial Details:
  • Approval Date & Agency: December 14, 2023, PMDA (Japan)
  • Trial Identifier: NCT07054970 (ClinicalTrials.gov)
  • Subject Scale & Design: 172 healthy adult male subjects / Double-blind, randomized, active-controlled Phase 1 clinical trial
  • Key Results:
    1. Pharmacokinetics (PK): Primary endpoints ($AUC_{0-inf}$, $C_{max}$) fell within the predefined 90% confidence interval equivalence limits, demonstrating PK equivalence to reference Cosentyx.
    2. Safety: Treatment-emergent adverse events (TEAE) reported in 65.5% of subjects, showing comparable rates between arms (mostly mild or moderate). One serious adverse event occurred in the reference group.
    3. Immunogenicity: ADA/NAb incidence remained low and similar across groups without clinically meaningful safety impacts.
• Board Resolution / Fact Confirmation Date: June 26, 2026
• Investment Caution: Submission of approval application does not guarantee final regulatory approval, and commercialization plans may change or be withdrawn during evaluation.

📝 Editor’s Comment (Key Follow-up Checkpoint)

📌 MFDS Final Approval Status and Global Regulatory Filings

This disclosure relates to Celltrion’s filing for marketing authorization of CT-P55 with the Korean MFDS, making it essential to follow whether final regulatory approval is granted. Tracking official approval in South Korea as well as subsequent filings in major global markets (such as the US and EU) is key to assessing the product’s ultimate timeline to market and commercial impact. Updates on approval progress and additional applications can be checked in future regulatory disclosures or under the ‘Ongoing Research and Development Activities’ section in upcoming periodic filings (Quarterly, Half-Yearly, or Annual Business Reports).

📢 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.

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