iRegene Therapeutics, a biotechnology company based in Chengdu, China, has announced the completion of its Series B+ financing round, securing over RMB 300 million (about $40 million). The round was co-led by Northern Light Venture Capital, Chuangjing Capital, and OneHealth Haihe Capital, with additional support from other investors.
This marks the most significant single investment in China’s induced pluripotent stem cell (iPSC) sector in recent years, underscoring strong investor confidence in iRegene’s leadership and long-term strategy.
The funding arrives shortly after a major regulatory milestone for iRegene’s flagship product, NouvNeu001. In August 2025, the U.S. Food and Drug Administration granted Fast Track Designation to NouvNeu001, making it the first allogeneic iPSC-derived cell therapy for Parkinson’s disease to receive this recognition. This designation is intended to expedite the development and review of therapies that address serious conditions and fill unmet medical needs.
NouvNeu001 is a clinical-stage therapy composed of dopaminergic progenitor cells derived from iPSCs. It is designed to treat Parkinson’s disease by replacing damaged neurons with healthy, lab-grown cells. The treatment has already received regulatory clearance to begin clinical trials in both China and the United States. In April 2025, iRegene launched a multicenter Phase II trial in China, following promising Phase I results that showed strong safety and tolerability up to 15 months post-transplantation.
Notably, patients did not require immunosuppressants after the sixth month, and PET imaging confirmed long-term survival of the transplanted cells. Clinical outcomes included significant improvements in motor function and extended periods of symptom relief.
The Series B+ funding will be used to accelerate global clinical development of NouvNeu001, as well as NouvSight001, a therapy targeting retinal degenerative diseases. iRegene also plans to invest in early-stage research, expand its clinical and operational teams, and enhance its manufacturing capabilities to support future growth.
This funding round builds on a series of financings completed earlier in the year and positions iRegene as a key player in the global cell therapy landscape. The company’s chemically induced platform offers a scalable and cost-effective approach to producing off-the-shelf cell therapies, making advanced treatments more accessible to patients worldwide.
KEY QUOTE:
“We are deeply grateful for the trust and continued support of our investors, as well as the dedication of the iRegene team. Our mission is to pioneer transformative therapies that truly reverse disease progression for patients worldwide. This financing will accelerate our global clinical programs, expand iRegene manufacturing capabilities, and advance our international footprint expansion, bringing us closer to delivering these life-changing therapies to the patients.”
Dr. Jun Wei, Founder and CEO of iRegene Therapeutics
