NouvNeu003

NouvNeu003 is an induced pluripotent stem cell (iPSC)-derived, off-the-shelf allogeneic cell therapy product being developed by iRegene Therapeutics for the treatment of early-onset Parkinson's disease. The therapy is developed using iRegene's proprietary 'AI + chemical induction' platform, which uses chemical induction to precisely reprogram cell fate and optimize cellular functions. NouvNeu003 received IND approval from China's NMPA in December 2023 to enter Phase I clinical trials, making it the world's first iPSC-derived, off-the-shelf cell therapy product for early-onset Parkinson's disease to enter the registered clinical stage. As of early 2026, Phase I trials have been completed in China. The drug represents iRegene's second product candidate targeting Parkinson's disease, following their lead product NouvNeu001 which targets mid-to-late stage Parkinson's disease.