[Disclosure] Celltrion (068270) Obtains Marketing Authorization from Korean MFDS for ‘Steqeyma (CT-P43)’

Fact Source: Financial Supervisory Service (DART) / 2024-06-12

Disclosure Type: Major Management Matters Related to Investment Decisions

💡 3-Second Summary

Celltrion has obtained official marketing authorization from the Korean Ministry of Food and Drug Safety (MFDS) for ‘Steqeyma (CT-P43),’ a biosimilar of the reference drug Stelara.

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

• Authorized Product: Steqeyma (CT-P43, Stelara biosimilar, ingredient name: Ustekinumab)
• Target Diseases (Indications):
  • Plaque psoriasis
  • Pediatric plaque psoriasis
  • Psoriatic arthritis
  • Crohn’s disease
  • Ulcerative colitis
• Submission and Approval Dates:
  • Submission Date: June 15, 2023
  • Approval Date: June 12, 2024
• Regulatory Body: Korean Ministry of Food and Drug Safety (MFDS)
• Expected Effects: Marketing authorization was secured for all indications approved for the reference drug. The company expects to provide alternative treatment options to a broader patient population in the future.

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

• Completion of Domestic Regulatory Process: This filing formally notifies that the domestic approval process for ‘Steqeyma,’ which was initiated on June 15, 2023, has concluded with final marketing authorization granted by the MFDS.
• Complete Indication Matching: The regulatory approval covers all primary indications held by the reference drug, including plaque psoriasis, pediatric plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, ensuring no target disease gaps.
• No Financial Performance Causes Specified: This disclosure focuses on the acquisition of the product license. It does not contain information regarding future sales launch timelines, specific commercialization plans, or concrete causes regarding financial performance.

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

Celltrion’s latest disclosure confirms that its Stelara biosimilar, ‘Steqeyma,’ has secured regulatory marketing approval from the Korean MFDS across all indications approved for the reference drug. Following a review process of approximately one year, this milestone formally establishes the regulatory foundation required to supply the drug to patients in the domestic market.

For investors reviewing this announcement, the primary metric to follow is the ‘actual commercial launch schedule and domestic market release timing.’ The disclosure is strictly limited to the acquisition of the marketing authorization and expectations for providing treatment options, with no financial forecasts, sales distribution methods, or market share projections provided. Consequently, investors should focus on verifying actual launch milestones, including drug pricing registration and commercial supply chain readiness, in a systematic and factual manner.

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