iRegene Therapeutics Secures Series B+ Financing Following FDA Fast Track Designation for its Flagship Product NouvNeu001

CHENGDU, China, Sept. 9, 2025 /PRNewswire/ -- iRegene Therapeutics (Chengdu) Co., Ltd. ("iRegene" or the "Company"), a biotechnology company pioneering chemically induced allogeneic cell therapy, announced on September 4th the successful completion of its Series B+ financing round, co-led by Northern Light Venture Capital, Chuangjing Capital, and OneHealth Haihe Capital, along with participation from other investors. In August 2025, NouvNeu001 received Fast Track Designation (FTD) from the U.S. FDA, making it the world's first allogeneic iPSC-derived cell therapy for Parkinson's disease to achieve this milestone.

This round builds on a series of sizable financings completed in recent months, bringing iRegene's total funding to over RMB 300 million (~USD 40M). It makes the largest single financing in China's iPSC sector in recent years, highlighting the strong confidence of investor in iRegene's leadership position and long-term strategic vision.

The proceeds will be used to accelerate iRegene's global clinical development of NouvNeu001 for Parkinson's disease (PD), and NouvSight001 for retinal degenerative diseases, while also strengthening early-stage R&D, expanding clinical and operational teams, and advancing iRegene's manufacturing capabilities.

About NouvNeu001

iRegene's flagship product, NouvNeu001, is the world's first clinical-stage, iPSC-derived, allogeneic dopaminergic progenitor cell therapy for PD. NouvNeu001 received the China NMPA's IND clearance to initiate Phase I/II in China in Aug 2023, and received the FDA IND clearance to initiate Phase I in USA in June 2024. In April 2025, iRegene launched a multicenter Phase II clinical trial in China (NCT06167681).

Phase I results demonstrated:

• Excellent safety and tolerability observed up to 15 months post-transplantation, notably without the use of immunosuppressants after the 6th months.
• PET imaging confirmed long-term engraftment and survival of transplanted cells.
• Significant clinical efficacy, including marked improvement in MDS-UPDRS Part III motor scores and extended "on-time" duration, underscoring the strong competitiveness.

On August 15, 2025, NouvNeu001 was granted Fast Track Designation (FTD) from the U.S. FDA, becoming the first allogeneic iPSC-derived PD cell therapy worldwide to earn this recognition. This milestone follows the FDA's Special Exemption (SE) granted in March 2024, further validating iRegene's clinical data integrity, product quality system, and innovative therapeutic approach.

Key Development Timeline for NouvNeu001

CEO Statement

"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. "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."

About iRegene Therapeutics

Founded in 2017 by a team of international professionals, iRegene Therapeutics is the earliest biotech in the world to apply "Chemical induction" to precisely reprogram cell fate and optimize cellular functions. Leveraging this breakthrough platform, iRegene Therapeutics has built a robust pipeline targeting currently "incurable" diseases such as Parkinson's disease and blindness. As a leader in chemical induction, iRegene's proprietary system enables the efficient easy generation of human specific cell types with high purity, and enhanced functionality, pioneering the next generation of chemically derived cell therapies.

SOURCE iRegene therapeutics