[Disclosure] Celltrion (068270) Obtains Marketing Authorization from Korean MFDS for ‘Eydenzelt (CT-P42)’

Fact Source: Financial Supervisory Service (DART) / 2024-05-30

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 ‘Eydenzelt (CT-P42),’ a biosimilar of the reference drug Eylea.

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

• Authorized Product: Eydenzelt (CT-P42, Eylea biosimilar, ingredient name: Aflibercept)
• Target Diseases (Indications):
  • Treatment of neovascular (wet) age-related macular degeneration
  • Treatment of visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO)
  • Treatment of visual impairment due to diabetic macular edema
  • Treatment of visual impairment due to myopic choroidal neovascularization
• Submission and Approval Dates:
  • Submission Date: July 26, 2023
  • Approval Date: May 29, 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 ‘Eydenzelt,’ which was initiated on July 26, 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 wet age-related macular degeneration, macular edema secondary to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization, 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 Eylea biosimilar, ‘Eydenzelt,’ has secured regulatory marketing approval from the Korean MFDS across all indications approved for the reference drug. Following a review process of approximately ten months, 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.

📢 Disclaimer & Source Information

Source: This content was restructured and newly drafted based on the official submitted data from the Financial Supervisory Service (DART).

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