Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
ALTEOGEN received official product license approval from the Ministry of Food and Drug Safety (MFDS) for EYZANFY (ALT-L9), an Eylea biosimilar, covering all indications approved for the original drug.
📊 [Key Disclosure Details & Major Figures Summary]
- Product Name: EYZANFY Injection (Code Name: ALT-L9, Active Ingredient: Aflibercept)
- Approved Indications: All indications approved for the reference product (Eylea)
- Treatment of neovascular (wet) age-related macular degeneration
- Treatment of visual impairment due to macular edema secondary to retinal vein occlusion (branch or central RVO)
- Treatment of visual impairment due to diabetic macular edema
- Treatment of visual impairment due to choroidal neovascularization secondary to pathologic myopia
- Approval Authority & Timeline:
- Regulatory Body: Ministry of Food and Drug Safety (MFDS)
- Application Date: September 12, 2024
- Approval Date (Fact Date): May 14, 2026 (Date of official approval document receipt)
- Future Plans & Expected Effects:
- Domestic launch planned based on the product license approval
- Expected import substitution effect for the reference drug, improved patient access, and reduction of national health insurance financial burden
- Other Reference Matters: The disclosed information will be utilized for upcoming press releases and IR materials
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Domestic Launch Progress and Subsequent Filings Post-Approval
This disclosure formally reports the regulatory approval of the Eylea biosimilar (ALT-L9) in South Korea and its plan for a domestic product launch. Tracking the execution of domestic launch plans and related updates is essential because it allows investors to stay informed about the progress of product commercialization following licensing. Detailed updates can be cross-checked in subsequent periodic reports (Quarterly, Half-Yearly, and Annual Reports) and related disclosure filings.
📢 Disclaimer & Source Notice
Source: This content has been structured and newly created based on official filing data from the Financial Supervisory Service (DART).
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