
Cell Therapy Product Developer
Recently, iRegene, a Chinese induced pluripotent stem cell (iPSC) drug development company, announced the completion of its C1 financing round, raising RMB 210 million. The round was co-led by Photosynthesis Venture Capital and Xingze Capital. The funds will be primarily used to advance its core clinical pipeline, upgrade its technology platform, build a scalable production system, and lay out global clinical development and international commercial collaborations.

As a high-tech enterprise focused on the field of regenerative medicine, iRegene’s core competitiveness lies in its proprietary “AI + Chemically Induced” technology platform, aimed at addressing industry-wideiPSCSourceChallenges in the Efficient, Safe, and Scalable Translation of Cell Therapies. iRegene employs a purely chemical induction strategy, precisely regulating cell fate determinants through small-molecule compounds to achieve efficient and homogeneous differentiation of iPSCs into target functional cells.
Furthermore, the company’s independently developed AI-driven screening platform, integrated with a bioinformatics analysis system, deciphers the regulatory networks between induced pluripotent stem cells (iPSCs) and target cells. This enables the rapid identification of key driver genes and the screening of small-molecule compounds that effectively modulate these targets. By combining only a few small-molecule compounds with a fully defined chemical basal medium, large-scale synchronized differentiation of iPSCs can be achieved under serum-free and genetic modification-free conditions, thereby producing high-purity, residue-free specific functional cells.

Leveraging this foundational technology platform, NouvNeu001 Injection, an off-the-shelf dopaminergic precursor cell therapy product derived from induced pluripotent stem cells (iPSCs) and independently developed by iRegene, has recently achieved a series of milestone developments. The product officially initiated a multicenter Phase II clinical trial in April 2025 and completed dosing of the first cohort of patients in July of the same year. Subsequently, the drug received significant recognition from international regulatory authorities: it was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in August 2025, and further received Regenerative Medicine Advanced Therapy (RMAT) designation in December 2025, becoming the first iPSC-based product globally to secure both designations. Entering 2026, its clinical research continued to accelerate, with the first subject in the U.S. Phase II trial successfully dosed in February, and all enrolled patients in the Chinese Phase II clinical trial completing dosing in March.

In addition to its core product, NouvNeu001, iRegene is actively developing multiple innovative pipelines based on the same “AI + chemically induced” platform, gradually building a diversified product portfolio covering central nervous system disorders, ophthalmic diseases, and other major therapeutic areas.
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