[Disclosure] Alteogen(196170) Files for Domestic Marketing Authorization of Eylea Biosimilar ‘EYZANFY Inj.’

Source Fact: Financial Supervisory Service DART / 2024-09-12

Disclosure Type: Material Corporate Management Matters Related to Investment Decisions

💡 3-Second Summary

Following the successful completion of its global Phase 3 clinical trials, Alteogen has officially submitted an application for marketing authorization to the Ministry of Food and Drug Safety (MFDS) for ‘EYZANFY Inj. (ALT-L9)’, a biosimilar of the blockbuster ophthalmic drug Eylea.

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

• Filing Entity: Alteogen Co., Ltd. (Ticker: 196170)
• Product Name & Substance: EYZANFY Inj. (ALT-L9, Aflibercept)
• Target Indications: Applied for all approved indications of the originator drug, including:
  • Treatment of neovascular (wet) age-related macular degeneration (AMD)
  • Treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO)
  • Treatment of visual impairment due to diabetic macular edema (DME)
  • Treatment of visual impairment due to myopic choroidal neovascularization (mCNV)
• Application Timeline & Authority:
  • Submission Date: September 12, 2024
  • Regulatory Agency: South Korea Ministry of Food and Drug Safety (MFDS)
• Phase 3 Clinical Trial Summary (EudraCT No. 2021-004530-11):
  • Trial Period & Sample Size: June 02, 2022 ~ February 20, 2024 / 431 patients (ALT-L9 group: 216, Eylea group: 215)
  • Efficacy Results: Analysis of the primary endpoint—the change from baseline in Best Corrected Visual Acuity (BCVA) at week 8—demonstrated that the 90% and 95% confidence intervals of the mean difference fell entirely within the pre-defined equivalence margin ($\pm$3.49 letters), confirming therapeutic equivalence.
  • Safety Results: The safety profile remained comparable between both treatment arms. Serious systemic adverse events occurred in 25 patients (11.6%) in both cohorts. Serious ocular adverse events were reported in 1 patient (0.5%) in the ALT-L9 group and 3 patients (1.4%) in the Eylea group.

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

This filing indicates that Alteogen has translated its global Phase 3 dataset into formal administrative action to pioneer domestic commercialization. Rather than acting as a short-term trading event, this represents a mid-to-long-term development aimed at establishing proprietary commercial sales channels and capturing revenue share from a blockbuster foreign pharmaceutical. It directly correlates with the potential expansion of the company’s operational fundamental.

However, market participants must carefully observe the latent risks detailed in the mandatory warning section. Filing for a Biologics License Application (BLA) does not guarantee final marketing approval from the MFDS. The review process may face conditional data requests or administrative bottlenecks that could trigger a potential delay in the commercial timeline, and absolute failure to secure approval could force management to alter or abandon its distribution pipeline. Consequently, a prudent analytical approach involves assessing this as an institutional milestone while monitoring upcoming regulatory checkpoints and final approval timelines before pricing in guaranteed long-term commercial yields.

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

Alteogen’s biosimilar pipeline is taking a major step closer to commercial realization. This regulatory filing with the MFDS follows their initial submission in Europe, backed by rigorous Phase 3 clinical trial metrics that proved strict therapeutic equivalence to the originator drug, Eylea. Given Eylea’s massive presence in the global eye-disease market, securing domestic approval will likely create a favorable import-substitution effect and lower financial strains on the national healthcare system. Because the regulatory agency’s detailed dossier review inevitably requires a structured review timeline, investors would be well-advised to rely on official regulatory updates rather than betting on speculative or premature conclusions within retail forums.

📢 Disclaimer and Source Information

Source: This content has been structured and newly written based on the official data submitted to the Electronic Disclosure System (DART) of the Financial Supervisory Service.

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