Ruijian Medicine's Parkinson’s Cell Therapy NouvNeu001 Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation

On December 22, iRegene announced the injection NouvNeu001 independently developed by the company.（iPSC Chemically-Induced Universal Dopaminergic Neural Progenitor CellsGranted the Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA. Previously, the product had already received FDA Fast Track designation in August this year.

Parkinson's disease is the second most common neurodegenerative disease globally. Current therapies are mostly focused on symptomatic treatment or "complication management," lacking "disease-modifying" treatments. The development of NouvNeu001 directly addresses this clinical need.Aiming to fundamentally repair the loss of dopaminergic neurons through cell replacement therapy and reverse the progression of Parkinson's disease., bringing clinical benefits that may alter the course of the disease for patients.

iRegene's innovative "AI + chemical induction" technology can achieve directional differentiation of high-purity specific dopaminergic neuron subtypes and simultaneously complete various functional modifications, including cellular biochemistry, during the induction process. After transplantation, the cells compensate for the loss of functional cells at the lesion site, ultimately repairing circuit deficiencies caused by Parkinson’s disease in patients and restoring their dopamine autocrine function, thereby demonstrating potential for reversing disease progression.

In addition, iRegene adopts a single-needle-path stereotactic drug delivery method, ensuring the safety of the drug administration process while achieving long-term survival and integration of transplanted cells. Efficacy data shows that 12 months after a single administration, motor function scores (MDS-UPDRS III) improved by an average of 30.6 points (52.82% improvement) in the OFF state and by an average of 13.6 points (54.67% improvement) in the ON state. These statistically significant clinical results demonstrate the therapeutic value of NouvNeu001 in the field of Parkinson's disease.

References:
[1]Clinical Data Again Receives FDA Recognition, NouvNeu001 Obtains RMAT Designation, Becoming the World's First iPSC Product with Both FTD and RMAT Recognitions. From https://mp.weixin.qq.com/s/Z_tGZDFcnuH2uWlqIsC3zw

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