Alteogen Secures Domestic Approval for Eylea Biosimilar ‘Eyenefy Injection’

Securing Domestic Approval Following Europe

Subsidiary Also Advancing Development of 'ALTS-OP01'

On May 15, Alteogen announced that it has received domestic product approval from the Ministry of Food and Drug Safety for 'Eyenefy® Injection (project name ALT-L9, an aflibercept biosimilar)'.

Daejeon Alteogen Headquarters and Research Institute View. Alteogen

ALT-L9, which was approved in Europe last year under the product name 'Eyluxvi®', has now also secured approval in Korea. Based on this product approval, Alteogen plans to launch the product in the domestic market.

The approval for Eyenefy Injection is based on the results of global phase 3 clinical trials conducted in 12 countries, including Europe, Korea, and Japan, by its subsidiary Alteogen Biologics. In these trials, ALT-L9 demonstrated therapeutic equivalence and safety compared to the original drug, Eylea.

Alteogen Biologics is currently developing 'ALTS-OP01', a candidate therapeutic for macular degeneration, leveraging its global clinical and regulatory capabilities. ALTS-OP01 is a new drug candidate designed to improve efficacy and extend dosing intervals compared to existing treatments. Alteogen is also strengthening its pipeline for subsequent ophthalmic therapies, including filing an international patent (PCT) for high-dose formulation technology.

Tae-yeon Jeon, CEO of Alteogen, stated, "Eyenefy Injection was developed based on Alteogen's accumulated expertise in protein drug development and formulation research, and our subsidiary Alteogen Biologics led the global clinical development and regulatory procedures. Securing domestic product approval following European approval demonstrates Alteogen's capabilities in global clinical development and regulatory compliance."

He added, "Building on our accumulated clinical development capabilities and regulatory experience, we will continue to grow as a global biopharmaceutical company with both platform technology and development expertise."

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