Ilias Biologics (CEO Choi Cheol-hee, hereinafter Ilias), a company developing exosome-based precision therapy, announced on the 2nd that its anti-inflammatory improved exosome therapy candidate was finally selected as a candidate for support in the '2025 Bio Challenger' program hosted by the Ministry of Food and Drug Safety (hereinafter MFDS).
The candidate substances selected this time are currently in the non-clinical stage, and this program will enable a more systematic and expedited process of clinical entry and commercialization preparation.
"BioChallenger" is a customized program run by the Ministry of Food and Drug Safety (MFDS) that supports the entire biopharmaceutical development process. It provides practical advice and consulting at every stage, from early development to product approval. Beginning in 2025, the scope of support, previously limited to clinical-stage products, will be expanded to include non-clinical stages. Eligible candidates will be selected based on a comprehensive evaluation of innovation, medical demand, and commercialization potential.
With this selection, Ilias will receive hands-on support, including expert advice on non-clinical and clinical trial design, support for trial result interpretation, and customized regulatory consultation. The company recently held a kickoff meeting with the Ministry of Food and Drug Safety's Cell and Gene Therapy Division, and substantive discussions regarding the development of exosome therapeutics have reportedly taken place.
Currently, the Ministry of Food and Drug Safety is developing the world's first quality, non-clinical, and clinical evaluation guidelines for exosome therapeutics, and related systems are being reorganized. ILIAS expects that this program will enable it to develop a strategy that meets regulatory requirements and quickly establish the foundation necessary for future domestic and international approval processes.
Meanwhile, Ilias's candidate substance was previously selected for a national new drug development project supported by the Korea Drug Development Foundation (KDDF). The company plans to further enhance R&D synergy and commercialization potential by linking this BioChallenger program with existing government R&D projects.
Choi Cheol-hee, CEO of Ilias, said, “With this selection as a BioChallenger, we will be able to receive practical and strategic support from the Ministry of Food and Drug Safety from non-clinical to clinical and approval stages,” and added, “We will further accelerate the development of anti-inflammatory exosome treatments through linkage with existing national R&D support projects.”
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