Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Alteogen submitted an application for marketing authorization to the Ministry of Food and Drug Safety (MFDS) for EYZANFY (aflibercept, ALT-L9), an Eylea biosimilar, for all approved indications including wet age-related macular degeneration, based on Phase 3 clinical trial results.
📊 [Key Disclosure Details & Financial Highlights]
- Product Name: EYZANFY Injection (aflibercept, ALT-L9)
- Target Indications:
- Neovascular (wet) age-related macular degeneration (nAMD)
- Visual impairment due to macular edema secondary to retinal vein occlusion (RVO)
- Visual impairment due to diabetic macular edema (DME)
- Visual impairment due to myopic choroidal neovascularization (mCNV)
- Application Date & Authority: September 12, 2024 / Ministry of Food and Drug Safety (MFDS)
- Phase 3 Clinical Trial Summary & Results:
- Trial Period: 2022-06-02 ~ 2024-02-20
- Sample Size: Total 431 subjects (ALT-L9 arm: 216, Eylea arm: 215)
- Efficacy: Primary endpoint evaluation of Best Corrected Visual Acuity (BCVA) change at 8 weeks from baseline showed that the confidence intervals fell within the pre-defined equivalence margin (±3.49 letters), demonstrating therapeutic equivalence to Eylea.
- Safety:
- Serious systemic adverse events reported in 25 subjects (11.6%) per arm (ischemic stroke reported in 1 subject [0.5%] in ALT-L9 arm vs. 3 subjects [1.4%] in Eylea arm)
- Serious ocular adverse events reported in 1 subject (0.5%) in ALT-L9 arm vs. 3 subjects (1.4%) in Eylea arm
- Future Plans: Following filings in Europe and South Korea based on Phase 3 data, Alteogen plans to apply for regulatory approvals in additional countries.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Why Verifying Regulatory Review Outcomes and Final Approval Status Is Necessary
This disclosure serves as an informational filing regarding the official submission of a marketing authorization application for the Eylea biosimilar candidate (ALT-L9) to the Korean regulatory body following Phase 3 clinical trials.
Checking this follow-up item is necessary because the actual commercialization and domestic market launch of the product depend directly on the regulatory review, potential requests for supplementary data, and the final approval decision by the MFDS. Since filing an application does not guarantee final approval, monitoring whether the official marketing approval disclosure is subsequently issued is essential to determine the pipeline’s transition into full commercial status.
The final regulatory outcome can be confirmed in future marketing approval disclosures or upcoming periodic reports on DART.
📢 Disclaimer & Source Information
Source: This content was structured and generated based on official submission data from the Financial Supervisory Service’s Data Analysis, Retrieval and Transfer System (DART).
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