NouvNeu004

NouvNeu004 is an allogeneic, off-the-shelf cell therapy derived from induced pluripotent stem cells (iPSCs) for the treatment of Multiple System Atrophy (MSA). Developed by iRegene Therapeutics, the therapy is produced using a proprietary chemical induction platform that utilizes small molecules to reprogram cell fate, avoiding the use of traditional genetic engineering. This regenerative medicine approach is designed to address the progressive neurodegeneration characteristic of MSA. NouvNeu004 has received all-stage (Phase I-III) IND approval from China's NMPA and has been granted several FDA special designations, including Fast Track and RMAT. As of mid-2025, IND applications have been submitted to both the NMPA and the U.S. FDA to initiate clinical evaluation.