Alteogen (196170) said in a filing that Korea's Ministry of Food and Drug Safety approved its Eylea biosimilar, Eyzenfy (code ALT-L9, ingredient aflibercept), on May 14, nearly 20 months after the company applied in September 2024.
The approval covers every indication the original Eylea holds in Korea: wet age-related macular degeneration, diabetic macular edema, macular edema from retinal vein occlusion, and vision loss from myopic choroidal neovascularization. The filing states Alteogen's next step is pursuing a domestic launch, without giving a date, price or distribution partner.
Unlike Alteogen's ALT-B4 licensing deals with Novartis and MSD, Eyzenfy is the company's own branded product rather than a licensed technology, so the filing carries no milestone or royalty figure. The company frames the commercial case only in general terms, as import substitution for the originator drug and a lower price point that could expand patient access.
Alteogen's FY2025 revenue of KRW 215.9 billion came almost entirely from licensing fees rather than product sales; Eyzenfy would be a rare direct product-sales line if it launches. The filing does not disclose expected sales.
215.9 billion won.
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| Symbol | Last Price |
|---|---|
| 196170Alteogen Inc. | ₩288,500 +1.9% |