Ruijian Pharmaceuticals Secures Over RMB 300 Million in Series B+ Financing to Advance Global Clinical Development of Parkinson’s and Ophthalmology iPSC Therapies

Recently, iRegene (Chengdu) Co., Ltd. (hereinafter referred to as "iRegene" or "the Company") announced the completion of its B+ round of financing. The funds from this round will be used to accelerate the clinical advancement in China and abroad of the company’s Parkinson's disease treatment products NouvNeu001/NouvNeu003 and ophthalmic treatment product NouvSight001. Additionally, the funding will support the strengthening of the company’s early R&D and clinical team building, as well as enhance the company’s industrialization capabilities.

iRegene was founded in 2017 and is committed to becoming a globally leading universal chemical-induced cell therapy pharmaceutical enterprise. NouvNeu001 injection, independently developed by iRegene, as the world's first iPSC-derived universal dopaminergic precursor cell therapy product to enter clinical trials, officially launched its multi-center Phase II clinical trial in April 2025. Preliminary Phase I clinical data showed that, in patients 15 months post-transplant, the treatment demonstrated good safety and tolerability. PET imaging analysis also confirmed that, with increased transplantation time, the cells achieved long-term survival in the body without immunosuppressants. Behavioral and non-behavioral efficacy indicators have already shown significant global competitive advantages, with UPDRS III motor function showing substantial improvement, extended "on" periods, and other positive outcomes.

On August 15, 2025, NouvNeu001 Injection was granted Fast Track Designation (FTD) by the FDA and approved for an expanded scope of application. This marks the first-ever FTD qualification for a universal iPSC-derived Parkinson's cell therapy product globally. Additionally, this follows the Special Exemption granted by the FDA in March 2024, with further support now provided through the FDA’s FTD accelerated pathway. This significant milestone indicates that NouvNeu001 has officially entered the international accelerated approval track and demonstrates the FDA's strong recognition of iRegene's clinical data for NouvNeu001.

In addition, iRegene's self-developed product NouvNeu003 for early-onset Parkinson's disease was officially approved in China to enter Phase I clinical trials in December 2023. It has become the world’s first iPSC-derived universal cell therapy product for early-onset Parkinson's disease to enter the registered clinical stage. This product addresses the increasingly younger onset of Parkinson's disease. Currently, NouvNeu003 has completed Phase I clinical trials, marking an important step for iRegene in covering the entire course of Parkinson's disease.

At the same time, iRegene continues to explore in the field of ophthalmic diseases. NouvSight001, the company's breakthrough ophthalmic product, received Orphan Drug Designation (ODD) from the U.S. FDA in March 2024. This product is aimed at treating "a series of retinitis pigmentosa indications" and is the first universal iPSC-derived ophthalmic cell therapy product developed by iRegene.

Dr. Wei Jun, founder and CEO of iRegene, stated: iRegene has always adhered to the attitude of a pioneer, hoping to achieve a breakthrough from 0 to 1 in the field of major international diseases. The iRegene team has consistently focused on genuine clinical needs and patient requirements, meticulously developing entirely new therapies that can truly "reverse disease progression." This round of financing will greatly accelerate iRegene's international development and industrial construction, span cycles, and expedite product launches as soon as possible.