
Cell Therapy Product Developer
On July 2, 2026, iRegene Therapeutics Co., Ltd. (hereinafter referred to as “iRegene Therapeutics” or the “Company”) announced the successful completion of its C+ round financing, raising RMB 260 million. The round was led by Chengdu Science and Technology Innovation Investment Group, with participation from CSC Financial Capital, Wuxi Venture Capital, Dingtai Star, Nanjing New Foundation, and Hony Capital, among others. Existing shareholders Yuanxi Haihe and GSR United Runpu Yuanfeng continued to increase their investments.

As a high-tech enterprise focused on the field of regenerative medicine, iRegene Therapeutics' core competitiveness lies in its proprietary "AI + Chemical Induction" technology platform, aimed at addressing industry-wideiPSCSourceAddressing the Challenge of Efficient, Safe, and Scalable Translation of Cell Therapies. iRegene Therapeutics 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 iPSCs and target cells to rapidly identify key driver genes and screen for small-molecule compounds capable of effectively modulating 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, yielding high-purity, residue-free specific functional cells.

Leveraging this foundational technology platform, NouvNeu001 Injection, an off-the-shelf dopaminergic progenitor cell therapy product derived from induced pluripotent stem cells (iPSCs) and independently developed by iRegene Therapeutics, has recently achieved a series of milestone progressions. The product officially launched its 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 simultaneously. Entering 2026, its clinical development continued to accelerate, with the successful dosing of the first subject in the U.S. Phase II trial completed in February, followed by the completion of dosing for all enrolled patients in the China Phase II clinical trial in March.

In addition to its core product, NouvNeu001, iRegene Therapeutics 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 disease areas.
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