[Disclosure] Celltrion (068270) Secures US FDA Final Marketing Authorization for ‘Stelara Biosimilar (CT-P43)’ Steqeyma

Source Facts: Financial Supervisory Service Electronic Disclosure System (DART) / 2024-12-18

Disclosure Type: Major Management Matters Related to Investment Decisions

💡 3-Second Summary

Celltrion has obtained final marketing authorization from the US Food and Drug Administration (FDA) for ‘Steqeyma’ (a biosimilar to Stelara), and plans to sell the product across the United States through its local US subsidiary.

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

• Authorized Brand & Substance: Steqeyma (CT-P43, Stelara biosimilar) / Active substance: Ustekinumab.
• Approved Indications: Secured final marketing approval for all indications held by the reference biological product, which include:
  • Plaque psoriasis
  • Pediatric plaque psoriasis
  • Psoriatic arthritis
  • Pediatric psoriatic arthritis
  • Crohn’s disease
  • Ulcerative colitis
• Key Administrative Timeline:
  • Application Date: June 30, 2023 (Local time)
  • Approval Date: December 17, 2024 (Local time)
• Regulatory Body: US Food and Drug Administration (FDA)
• Commercialization Plan: Celltrion plans to sell Steqeyma (CT-P43) across the United States through its local US subsidiary.

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

• Acquisition of Official US Marketing Rights: Final marketing authorization represents the transition from clinical development and regulatory review to official commercial clearance, allowing the product to be distributed and sold in the US market. Securing approval for all indications of the reference biologic provides the baseline necessary to supply the product to the specified patient populations.
• Regulatory Timeline Clearance: Having completed the regulatory review approximately one year and six months after the initial application in June 2023, the product has formally cleared the FDA’s administrative approval process.
• Monitoring Sales Execution by Local Subsidiary: While the marketing authorization is secured, verifying the subsequent timeline for actual market entry is required. Tracking the progress toward commercial launch will depend on the subsequent distribution plans carried out by the local US subsidiary to sell the product across the country.

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

The final marketing authorization granted by the US FDA marks the successful conclusion of the clinical development and regulatory review phases, establishing the legal framework to commercialize CT-P43 under the brand name Steqeyma. Securing approval for all indications of the reference biologic fulfills the necessary regulatory requirements to commence supply operations in the US market.

With the regulatory hurdle cleared, the focus of future evaluation shifts toward the milestones required for the actual commercial release. As outlined in the disclosure, the products will be sold through a local US subsidiary, making the specific launch schedules and distribution preparations by this entity the key parameters to monitor.

Going forward, investors should monitor the subsequent announcement regarding the launch and distribution timelines and reference them against the official plans disclosed in this filing.

📢 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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