Ruijian Medicine Secures FDA Special Exemption for NouvNeu004, the World’s First iPSC-Derived Cell Therapy for Multiple System Atrophy, Advancing into Global Phase I Clinical Trial

On November 26, 2025, the U.S. FDA officially granted iRegene(hereinafter referred to as "iRegene")iRegene's NouvNeu004 Injection Granted "Special Exemption" and Further Approved for Multiple System Atrophy（Multiple System Atrophy, MSA）The international Phase I clinical trial. This follows the approval by the China National Medical Products Administration on October 23, 2025.（NMPA）Following the formal approval of the I-III phase full-cycle clinical trial application for NouvNeu004 injection, NouvNeu004 injection has achieved further significant international progress. Thus far, iRegene has established a leading position in the field of cell therapy for central nervous system diseases. Whether it is NouvNeu001 for Parkinson's disease or NouvNeu004 for treating multiple system atrophy, both are the world’s first iPSC-derived universal cell drugs. Both have been granted "Special Exemption" status by the FDA and have achieved dual submissions and approvals in both China and the United States. Notably, iRegene's NouvNeu001 is also the first product to be granted "Special Exemption" status by the FDA, fully demonstrating iRegene's pioneering spirit on the international stage.

Multiple System Atrophy (MSA) is a rapidly progressing adult neurodegenerative disease. The pathological core of MSA lies in the abnormal aggregation of α-synuclein in oligodendrocytes, leading to myelin damage and nerve conduction disorders, which gradually destroys multiple key brain regions. This mechanism is fundamentally different from neurodegenerative diseases such as Parkinson's disease. As a result, conventional neurological treatment strategies often show minimal efficacy for MSA, with patients exhibiting complex clinical manifestations and extremely challenging diagnosis and treatment. MSA progresses rapidly, and most patients face life-threatening conditions within 6 to 10 years after diagnosis. Currently, there are no specific therapies available globally that can delay or halt the progression of the disease. NouvNeu004 injection adopts a novel composite mechanism to address the dilemma of having no effective treatment for MSA.

NouvNeu004 Injection Adopts an Innovative "Neurotrophic + Neural Reconstruction" Combination Treatment Strategy. Its Multi-Action Mechanism Includes: Providing Nutritional Support to Endangered Cells in the Lesion Area, Preventing Further Cell Death; Meanwhile, Inducing Differentiation into Neurons Through Microenvironment Stimulation at Multiple Lesion Sites, Achieving Systemic Nerve Repair and Functional Reconstruction. The Formal Granting of "Special Exemption" Status by the U.S. FDA to NouvNeu004 Injection, Along with the Approval of Its International Clinical Trial Application for Multiple System Atrophy, Fully Demonstrates the FDA's Recognition of iRegene’s Innovative Products.

Dr. Wei Jun, CEO of iRegene, stated that the continuous clinical approval of NouvNeu004 in both China and the United States, along with the official granting of the "Special Exemption" qualification by the FDA, has solidified iRegene's leading international position in the field of cell therapy for central nervous system diseases, while providing MSA patients with unprecedented treatment options.

iRegene's global competitiveness in the field of central nervous system diseases is accelerating. Its first product targeting Parkinson's disease, NouvNeu001, has already secured a place in the first tier of global pipelines of the same type and has gained international recognition repeatedly: In March 2024, after receiving FDA special exemption, it was again approved by the FDA in June of the same year to initiate international multicenter Phase I clinical trials in the United States and other countries. On August 15, 2025, NouvNeu001 made further progress and was granted Fast Track designation by the FDA.（Fast Track Designation, FTD）, becoming the world's first iPSC-derived universal Parkinson's cell therapy product to receive this designation. The continued clinical approval of NouvNeu004 in both China and the U.S., along with the FDA once again granting it "Special Exemption" status, further confirms the advanced nature of iRegene's disruptive R&D platform, the robustness of its innovative CMC system, and the high execution efficiency of its international team.

This series of milestone events, together with the international clinical approval of NouvNeu004, jointly confirm iRegene's technical advantages centered on the "AI + chemical induction" platform, as well as its continuous innovation capabilities and global influence in the field of cell therapy.

References:

1.https://mp.weixin.qq.com/s/HlTEAgCnK0S7qCzJJQvUlQhttps://mp.weixin.qq.com/s/HlTEAgCnK0S7qCzJJQvUlQ

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