By Fineline Cube 
China-based iRegene Therapeutics announced on August 15, 2025, that its self-developed injectable product, NouvNeu001, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). This designation also allows for an expanded scope of application for other compassionate use cases. This marks the world’s first FTD for an off-the-shelf iPSC-derived Parkinson’s cell therapy product.
Product Overview
NouvNeu001 is a Class 1 biologic developed entirely by iRegene Therapeutics. It is a chemically induced human dopaminergic neuron precursor. Through chemical induction, the product achieves high-purity neural subtype reconstruction and functional optimization. After transplantation, it forms connections with existing neurons in the body and enhances cellular secretion functions, thereby improving original lesions and achieving a comprehensive therapeutic effect.
Regulatory Milestone
This FTD approval follows the Special Exemption the product received from the FDA in March 2024. The designation reflects the FDA’s recognition of the potential of NouvNeu001 to address significant unmet medical needs in Parkinson’s disease treatment.-Fineline Info & Tech