196170 - Alteogen Inc.

196170 Summary
Biopharma
Stock Price & Overview
₩288,500 +5,500 (+1.94%) Close · Sep 4, 2026 KST
KOSDAQ | ₩KRW | Close: ₩288,500  ≈ US$206  ·  Market cap ₩20.1tn (≈ $14.4bn)

Alteogen's Eylea Biosimilar Eyzenfy Wins Full Korean Drug Approval Across All Original Indications

Alteogen (KOSDAQ:196170) disclosed on May 15 that Korea's Ministry of Food and Drug Safety (MFDS) approved Eyzenfy (code ALT-L9, ingredient aflibercept), its biosimilar of Regeneron/Bayer's Eylea, on May 14 — nearly 20 months after the September 2024 filing application. The approval covers every indication the original Eylea holds in Korea: wet age-related macular degeneration, macular edema from retinal vein occlusion (central or branch), diabetic macular edema, and vision impairment from myopic choroidal neovascularization. The filing states the company's next step is pursuing a domestic launch, without giving a date, pricing, or partner. Unlike Alteogen's ALT-B4 licensing deals, this is Alteogen's own branded product rather than a technology license, so it does not carry a milestone or royalty figure — the company frames the commercial case only qualitatively, as import substitution for the originator product and a lower price point that could expand patient access.

Read the original on DART ↗ Korean. DART is Korea's electronic disclosure system, run by the Financial Supervisory Service — the filing equivalent of EDGAR.
Korean form name: 투자판단관련주요경영사항 (아이젠피주(ALT-L9, 아일리아 바이오시밀러) 식약처 품목허가 승인)