- [ 메디채널 김갑성 기자 ] CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing EYLUXVI® to the reference product Eylea®
- Upon approval, EYLUXVI® will be Alteogen's second biosimilar product, following a Herceptin® biosimilar by Alteogen's license partner Qilu Pharmaceutical
DAEJEON, South Korea, July 28, 2025 -- Alteogen Inc. (KOSDAQ:196170) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EYLUXVI® (code name: ALT-L9), a biosimilar referencing Eylea® (aflibercept), co-developed with its subsidiary Alteogen Biologics Inc.
EYLUXVI® has been recommended for approval in adult patients for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch [RVO] or central [RVO]), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
"We are pleased to receive a positive CHMP recommendation for EYLUXVI®. This marks a significant milestone for Alteogen," said Soon-Jae Park, PhD, Chief Executive Officer of Alteogen. "We will provide a new, accessible treatment option for patients suffering from devastating ocular diseases such as wet age-related macular degeneration," he added.
The positive CHMP opinion was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. A randomized, double-masked, parallel group, multicenter Phase 3 study, conducted by Alteogen Biologics, demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between EYLUXVI® and reference aflibercept in patients with wet AMD.
Meanwhile, Alteogen licensed the development and commercialization rights for its anti-cancer drug Herceptin® biosimilar, ALT-L2, for the Chinese market to Qilu Pharmaceutical in 2017. Qilu Pharmaceutical completed its development, obtained approval from Chinese regulatory authorities last year, and is currently marketing the product in China. If approved, EYLUXVI® will be Alteogen's second commercialized biosimilar product.
About the ALT-L9 Phase 3 study
The study is a randomized, double-masked, parallel group phase 3 study conducted at 79 centers in 12 countries from June 2022 to February 2024, including follow-up through 52 weeks. 431 participants with wet AMD were randomized 1:1 to receive either ALT-L9 (n = 216) or Eylea® (n = 215). The primary efficacy endpoint of the study was the change from baseline in best corrected visual acuity (BCVA).
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 in KOSDAQ (196170.KQ). For more information, please visit: www.alteogen.com.
Contacts:
Alteogen Inc.
Junseok Jang,
Director, Corporate Communications & Investor Relations
jsjang@alteogen.com
Alteogen Biologics Inc.
Jisung Song
Senior Vice President, Business Development
jisung.song@alteogenbio.com
