On Oct. 27, 2025, Qureator announced a major milestone, confirming a fundamental shift in drug development under the FDA Modernization Act 2.0. We have enabled the world’s first FDA Investigational New Drug (IND) approval in oncology based solely on human vascularized organoid efficacy data, successfully replacing traditional animal efficacy (POC) studies.

Their proprietary AI-powered vTIME (vascularized tumor immune microenvironment) organ-on-a-chip platform generated the pivotal preclinical data. This allowed partner, SillaJen, to secure IND approval for their combination therapy, BAL0891, with an immune checkpoint inhibitor.

This breakthrough, also recognized by Korea’s MFDS, solidifies Qureator’s position as a global leader in next-generation preclinical platforms.