
Cell Therapy Product Developer

Recently,iRegeneAnnounced the completion of a RMB 210 million Series C1 financing round. This round was co-led by Guanghe Venture Capital and Xingze Capital.
The funds raised will be primarily used for the company's coreAdvancement of Cardiac Clinical Pipeline, “AI + Chemically Induced” PlatformContinuous upgrades, establishment of a large-scale production system, global clinical development, and strategic layout for international commercial partnerships.
The completion of this funding round marks further recognition by leading technology and healthcare investment firms of iRegene’s AI-driven platform capabilities, clinical pipeline execution, strategic layout in aging-related diseases, global operational excellence, and industrialization potential.
As its core products enter the accelerated clinical development phase in China and the United States, iRegene is evolving from a single-pipeline-driven company into a platform-based biotech with the capacity for sustained multi-pipeline output and global competitive potential.
iRegene’s core pipeline is independently developed.NouvNeu001 Injection, as the world’s first iPSC-derived universal dopaminergic precursor cell therapy product to enter clinical development, for the treatment of Parkinson’s disease.
On August 15, 2025, NouvNeu001 Injection was granted by the FDAFast Track Designation (FTD) Qualification, and approved to expand the scope of application,It is the first Fast Track Designation (FTD) globally for a universal iPSC-derived cell therapy product for Parkinson’s disease.In addition to receiving a Special Exemption from the FDA in March 2024, this product has further secured support through the FDA’s Fast Track Designation (FTD).
Furthermore, NouvNeu004, developed by the company for multiple system atrophy-parkinsonian type (MSA-P), has entered synchronized clinical development in China and the United States. This further validates iRegene’s AI platform in its extensibility to identify common pathological mechanisms across different neurological diseases, discover functional cell regulatory pathways, and generate candidate products.
In the field of ophthalmic diseases, the company has established the NouvSight series pipeline focused on irreversible visual function impairment. The successful advancement of this platform is expected to further expand its application boundaries in ophthalmology.
The formation of iRegene’s product portfolio signifies that the company is no longer merely a single-pipeline entity, but is evolving into a platform-based biotech driven by an AI-powered foundational platform, capable of continuously generating innovative cell therapy products.

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