Overview
Alteogen Inc. (KOSDAQ: 196170) announced on July 1st that its subsidiary, Altos Biologics Inc. has submitted Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for an aflibercept biosimilar ALT-L9, developed by Alteogen.
Phase 3 Clinical Trial for ALT-L9
- The Phase 3 clinical trial for ALT-L9 commenced with initial clinical trial approval in 2022, involving over 400 subjects across 12 countries.
- The study compared efficacy, safety, and immunogenicity against Eylea® in the indication of wet Age-related Macular Degeneration.
- Conducted in Europe, South Korea, and Japan, the trial evaluated changes in Best-Corrected Visual Acuity (BCVA) over an 8-week period as the primary endpoint.
- The study demonstrated therapeutic equivalence between ALT-L9 and Eylea®, prompting the submission of the Marketing Authorization Application.
About Approval
Altos Biologics expects to receive approval from EMA by 2025, aligned with the substance patent expiration, and intends to negotiate License Agreements with potential distributors worldwide.
Words from CEO: Alteogen
- Dr. Soon Jae Park, Chief Executive Officer of Alteogen, emphasized, ""The submission of Marketing Authorization Application for ALT-L9, developed by Alteogen and clinically tested by Altos Biologics, mark significant milestones in commercializing our proprietary products and gaining global clinical experience."" He added,
- This represents a crucial moment for Alteogen's growth as a global pharmaceutical company.
Product Approval in Different Places
- Following the European Marketing Authorization Application for ALT-L9, we plan to pursue product approvals in target markets including Korea,"" added Dr. Hyi Jeong Ji, Chief Executive Officer of Altos Biologics.
- Altos Biologics also aims to leverage its expertise gained from this trial in ophthalmic diseases to develop a novel multi-specific fusion protein therapeutic incorporating Tie2 regulators, in addition to anti-VEGF mechanisms similar to Eylea®, aimed at stabilizing blood vessels.
- This initiative aims to position the company as a leading developer of Best-in-Class treatments in the expanding market driven by aging demographics and related eye conditions.
About Alteogen Inc.
- 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).
