Alteogen Inc. Submits ALT-L9 MAA to EMA

Alteogen Inc., a leading biopharmaceutical company based in South Korea, has made a significant stride in the field of biologics with the recent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ALT-L9, an aflibercept biosimilar developed by its subsidiary, Altos Biologics Inc.

The submission of the MAA comes on the heels of a successful Phase 3 clinical trial for ALT-L9, which involved over 400 participants across 12 countries and focused on comparing the efficacy, safety, and immunogenicity of ALT-L9 against Eylea® in treating wet Age-related Macular Degeneration.

The results of the trial, which assessed changes in Best-Corrected Visual Acuity (BCVA) over an 8-week period, demonstrated that ALT-L9 was therapeutically equivalent to Eylea®, paving the way for the submission of the Marketing Authorization Application to the EMA.

Altos Biologics is optimistic about receiving approval from the EMA by 2025 and plans to enter into License Agreements with potential distributors worldwide. Dr. Soon Jae Park, CEO of Alteogen, emphasized the milestone's importance in commercializing their products and expanding their global presence, while Dr. Hyi Jeong Ji, CEO of Altos Biologics, outlined plans to seek product approvals in various markets, including Korea.

Looking ahead, Altos Biologics aims to leverage its expertise in ophthalmic diseases gained from the trial to develop a novel multi-specific fusion protein therapeutic that incorporates Tie2 regulators and anti-VEGF mechanisms akin to Eylea®. This strategic move is designed to position the company as a frontrunner in developing top-tier treatments for the growing market driven by aging populations and related eye conditions.

Alteogen Inc. specializes in pioneering biologics, including Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. The company's portfolio showcases clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed using proprietary NexP™-fusion and NexMab™ platform technologies. Additionally, Alteogen has introduced a proprietary recombinant human hyaluronidase enzyme through its Hybrozyme™ technology, enabling the subcutaneous administration of drugs typically given intravenously.

Alteogen's submission of the Marketing Authorization Application for ALT-L9 marks a significant advancement in the biopharmaceutical landscape, promising innovative treatments for patients with wet Age-related Macular Degeneration. With a strong focus on research and development, Altos Biologics is poised to make a lasting impact in the global healthcare sector, offering hope for improved therapies and better outcomes for individuals with ophthalmic conditions.