iRegene's technology has led to significant advancements, including the development of NouvNeu001, the first chemically induced iPSC-derived therapy to enter clinical trials, and NouvNeu003 for early-onset Parkinson's disease. Both products have completed Phase I trials, showing promising safety and efficacy results. The company is also advancing its ophthalmic therapy, which received Orphan Drug Designation from the U.S. FDA. With nearly 400 million RMB in financing, iRegene continues to drive innovation in cell therapy, aiming to provide transformative treatments for diseases with high unmet needs.
Key takeaways:
- iRegene Therapeutics was honored as one of Forbes China's 2025 Leading Enterprises in Industry Development for its pioneering work in regenerative medicine using an AI-powered, chemically induced cell therapy platform.
- The company has developed a proprietary AI-based platform that uses chemically induced pluripotent stem cells (iPSCs) to enhance cell therapy treatments, focusing on universal cell therapy products for incurable diseases.
- iRegene has entered a strategic partnership with Danaher Corporation to co-develop next-generation platforms, leading to the establishment of the iRegene - Danaher Joint Innovation Center for Chemically Induced Therapies and Microphysiology Systems.
- iRegene's first product, 'Human Dopaminergic Precursor Cell, NouvNeu001', is the world's first chemically induced iPSC-derived therapy to enter clinical trials, with Phase I trials completed and Phase II underway as of April 2025.