iRegene Therapeutics Raises $40M Series B+ Following FDA Fast Track Designation for Parkinson's Cell Therapy
核心洞察
iRegene Therapeutics (搜索) completed a Series B+ financing round bringing total funding to over $40 million, representing the largest single financing in China's iPSC sector in recent years.
The company's flagship product NouvNeu001 became the world's first allogeneic iPSC-derived cell therapy for Parkinson's disease to receive FDA Fast Track Designation in August 2025.
Phase I clinical results demonstrated excellent safety and tolerability up to 15 months post-transplantation without immunosuppressants after 6 months, with significant clinical efficacy improvements.
iRegene Therapeutics (搜索) (Chengdu) Co., Ltd., a biotechnology company pioneering chemically induced allogeneic cell therapy, announced the successful completion of its Series B+ financing round on September 4th, 2025. The round was co-led by Northern Light Venture Capital (搜索), Chuangjing Capital (搜索), and OneHealth Haihe Capital (搜索), with participation from other investors. This milestone comes following the FDA's Fast Track Designation for the company's flagship Parkinson's disease therapy NouvNeu001 in August 2025.
Landmark FDA Recognition for iPSC Cell Therapy
NouvNeu001 achieved a historic milestone by becoming the world's first allogeneic iPSC-derived cell therapy for Parkinson's disease to receive Fast Track Designation from the U.S. FDA on August 15, 2025. This recognition follows the FDA's Special Exemption granted in March 2024, validating iRegene's clinical data integrity, product quality system, and innovative therapeutic approach.
The therapy represents a breakthrough in Parkinson's treatment as the world's first clinical-stage, iPSC-derived, allogeneic dopaminergic progenitor cell therapy for the disease. NouvNeu001 received China NMPA's IND clearance to initiate Phase I/II trials in August 2023 and FDA IND clearance for Phase I trials in the United States in June 2024.
Promising Clinical Results Drive Investment Confidence
Phase I clinical results demonstrated compelling safety and efficacy profiles that have attracted significant investor interest. The trial showed excellent safety and tolerability observed up to 15 months post-transplantation, notably without the use of immunosuppressants after the 6th month. PET imaging confirmed long-term engraftment and survival of transplanted cells, while patients experienced significant clinical efficacy, including marked improvement in MDS-UPDRS Part III motor scores and extended "on-time" duration.
In April 2025, iRegene launched a multicenter Phase II clinical trial in China (NCT06167681), advancing the therapy toward potential commercialization.
Record-Breaking Financing in China's iPSC Sector
This Series B+ round builds on a series of sizable financings completed in recent months, bringing iRegene's total funding to over RMB 300 million (approximately USD 40 million). The financing represents the largest single funding round in China's iPSC sector in recent years, highlighting strong investor confidence in iRegene's leadership position and long-term strategic vision.
The proceeds will be strategically deployed to accelerate iRegene's global clinical development of NouvNeu001 for Parkinson's disease and NouvSight001 for retinal degenerative diseases. Additionally, funding will strengthen early-stage R&D efforts, expand clinical and operational teams, and advance the company's manufacturing capabilities.
Pioneering Chemical Induction Platform
Founded in 2017 by a team of international professionals, iRegene Therapeutics (搜索) positions itself as the earliest biotech company worldwide to apply "Chemical induction" to precisely reprogram cell fate and optimize cellular functions. This proprietary platform enables the efficient generation of human-specific cell types with high purity and enhanced functionality, pioneering the next generation of chemically derived cell therapies.
"We are deeply grateful for the trust and continued support of our investors, as well as the dedication of the iRegene team," said Dr. Jun Wei, Founder and CEO of iRegene Therapeutics (搜索). "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."
The company has built a robust pipeline targeting currently "incurable" diseases such as Parkinson's disease and blindness, leveraging its breakthrough chemical induction platform to address significant unmet medical needs in neurodegenerative and retinal degenerative conditions.