Alteogen Receives MFDS Approval For Aflibercept Biosimilar, EYZANFY (ALT-L9)

Secures domestic approval following European approval

Alteogen Inc. announced today that it has received marketing authorization from the Ministry of Food and Drug Safety (MFDS) for EYZANFY (aflibercept, code name: ALT-L9), a biosimilar to Eylea.

ALT-L9 previously received marketing authorization in Europe under the product name Eyluxvi in 2025, and the latest approval in Korea further expands the product’s approved territories.

The approval was based on the Phase 3 clinical trials conducted by Alteogen Biologics in 12 countries, including Europe, South Korea and Japan from June 2022 to February 2024. The comparative clinical evaluation involving 431 wAMD patients demonstrated that EYLUXVI's efficacy and safety are equivalent to Eylea. The study's results confirmed therapeutic equivalence and showed comparable safety profiles between the two treatments.

“The Korean approval of EYZANFY marks another important regulatory milestone for ALT-L9 following its approval in Europe,” said Tae-Yon Chun, PhD, CEO of Alteogen. “It also reflects the clinical development and regulatory capabilities that Alteogen and Alteogen Biologics have built in the ophthalmology field,” he added.

About Alteogen
Alteogen Inc. is a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics such as Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Alteogen's portfolio includes clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexP-fusion and NexMab platform technology, respectively. It also developed a proprietary recombinant human hyaluronidase enzyme utilizing Hybrozyme technology, which enables the large volume subcutaneous administration of drugs that are typically administered as an IV infusion. The company was founded in 2008 and listed on KOSDAQ (196170.KQ).