Ruijian Medicine Secures RMB 300 Million Series B Financing as Core iPSC-Derived Therapy Enters Phase II Clinical Trials

Sep 04, 2025 18:52 CST Updated 18:52

iRegene Therapeutics

Cell Therapy Product Developer

Today,iRegene(hereinafter referred to as "iRegene") announced the completion of its B+ round of financing. The company has cumulatively raised in its B round.300 Million Yuan Financing, becoming the largest financing in China's iPSC field in recent years.

This round of financing was jointly completed by Northern Light Venture Capital, Chengjing Capital, Yuanxi Haihe and other institutions, to accelerate the company's Parkinson's disease treatment products.NouvNeu001/NouvNeu003, and the clinical advancement of ophthalmology treatment product NouvSight001 in China and abroad, includingEarly R&D and Clinical Team Building at iRegene,And accelerate the company's industrialization capabilities.

四川睿健医疗科技股份有限公司 - 爱企查

iRegene was founded in 2017, with its headquarters located in Chengdu, Sichuan. The core team comes from the University of Cambridge in the UK.The Roslin Institute, UK.

The company focuses on small molecule chemical transcriptional regulation iPSC, and has built the first platform based on"AI + Chemical Induction"iRegene's cell drug development platform has multiple products in the fields of neurodegenerative diseases and ophthalmology.

iRegene's core pipeline is independently developed.NouvNeu001 Injection, as the world's first iPSC-derived universal dopaminergic progenitor cell therapy product to enter clinical trials, for the treatment of Parkinson's disease.

April 2025,NouvNeu001Official LaunchMulticenter Phase II Clinical Trial. Early Phase I clinical data indicate that patients transplanted for 15 months have demonstrated good safety and tolerability. Additionally, PET imaging analysis has confirmed the long-term survival of cells in the body without immunosuppressants as the transplantation time increases. Both behavioral and non-behavioral efficacy indicators have shown significant global market competitiveness advantages, with substantial improvement in UPDRS III motor function, extended "on" periods, and other positive outcomes.

On August 15, 2025, NouvNeu001 injection was granted by the FDAFast Track Designation (FTD) Qualification, and has been approved to expand its scope of application,It is the FTD designation for the world's first universal iPSC-derived Parkinson's cell therapy product.This also marks the product's further support from the FDA's FTD accelerated pathway, in addition to receiving the FDA Special Exemption in March 2024.

More importantly, the granting of this FTD also allows iRegene's NouvNeu001 to expand its scope of application for other compassionate uses, greatly enhancing the clinical application value and commercial potential of NouvNeu001.

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In addition, iRegene's self-developed product NouvNeu003 for early-onset Parkinson's disease was officially approved in China in December 2023 to enter Phase I clinical trials, becoming the world’s first iPSC-derived universal cell therapy product for early-onset Parkinson's disease to enter the registered clinical stage.

As a result, iRegene has achieved full lifecycle and full treatment cycle coverage for Parkinson's patients. Currently, NouvNeu003 has completed Phase I clinical trials. Safety and efficacy have been preliminarily validated, successfully achieving the study endpoints. This marks an important step for iRegene in covering the entire course of Parkinson’s disease.

At the same time, iRegene is continuously exploring in the field of ophthalmic diseases, with breakthroughs in the company.Ophthalmic Product NouvSight001In March 2024, iRegeneU.S. FDA Grants Orphan Drug Designation(Orphan Drug Designation, ODD). This product targets the treatment of "a series of retinitis pigmentosa indications" and is the first iPSC-derived ophthalmic off-the-shelf cell therapy product developed by iRegene.

Currently, iRegene has become one of the leading enterprises in the international pluripotent stem cell field. The completion of this round of financing will further solidify its strategic layout, deepen technological innovation and industrial transformation, and accelerate the realization of its global strategic goals.

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