Ilias Biologics (CEO Choi Cheol-hee, hereinafter referred to as Ilias), a company developing exosome-based precision therapeutics, announced that it has signed an agreement with the company after being selected for the 'Advanced Biomedical Product Clinical Sample Process Development and Production Demonstration' project of the 2025 First Advanced Medical Industry Leading-Based Demonstration Support Project.
This project is supported by the Ministry of Health and Welfare and organized by the Osong Medical Industry Promotion Foundation (KBIOHealth). With the support of the Ministry of Health and Welfare, the Osong Medical Industry Promotion Foundation provides technical services to medical research and development institutions in the industrial, academic, research, and hospital sectors, thereby strengthening domestic medical product development capabilities and promoting commercialization.
The Osong Advanced Medical Industry Promotion Foundation aims to strengthen the global competitiveness of domestic medical technologies by addressing bottlenecks in the development of new drugs and medical devices, supporting rapid regulatory approval, securing promising future technologies, and resolving technical difficulties in the field based on the basic technologies and experience accumulated through its projects.
With this project selection, ILIAS will proceed with the GMP-compliant production of active pharmaceutical ingredients for clinical trials of its flagship pipeline, ILB-202, under government support. The scope includes manufacturing and quality assessment of a working cell bank (WCB), GMP process production, and quality verification. Based on this, the company aims to initiate clinical trials for chronic kidney disease (CKD) indications in the second half of 2026.
ILB-202 is an anti-inflammatory treatment candidate developed based on ILIAS' proprietary exosome-modified platform EXPLOR®, and has demonstrated safety, tolerability, and exploratory pharmacodynamic properties in a global phase 1 clinical trial.
The Osong Medical Industry Promotion Foundation, a long-time partner of ILIAS, will produce GMP-level clinical samples of engineered exosomes for systemic administration through this collaboration. This will enable ILIAS to secure clinical manufacturing and quality control capabilities and establish a foundation for use in global clinical trials.
Ilias CEO Choi Cheol-hee said, “We believe that this national project has officially verified the reliability and industrial potential of ILB-202. We will quickly complete clinical sample production and quality verification with the goal of entering clinical trials for CKD indications in the second half of next year, and expand indications to various chronic inflammatory diseases to strengthen our competitiveness in the global market.”
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