Ruijian Pharmaceuticals Announces First Patient Dosed in China Phase II Multicenter Clinical Trial of NouvNeu001 Injection for Parkinson’s Disease

Recently, iRegene announced that the first patient has been successfully enrolled and dosed in the Phase II clinical trial of its self-developed NouvNeu001 injection for the treatment of moderate to severe Parkinson's disease at Beijing Hospital.

NouvNeu001 Injection Offers a New Approach to Cell Replacement Therapy for Parkinson's Disease. In August 2023, it received approval from China's NMPA to enter clinical trials, becoming the world’s first chemically induced iPSC-derived therapeutic product to reach the clinical stage. In June 2024, it obtained approval from the U.S. FDA to conduct overseas clinical research, achieving dual IND clearance in both China and the United States.「Dual Filing and Dual Approval」。

Currently,Phase I clinical data indicates that NouvNeu001 inGood safety and tolerability at 15 months post-transplant, cells achieved long-term survival in the body without immunosuppressants., and the data on behavioral and non-behavioral efficacy indicators have already demonstrated significant market advantages. NouvNeu001 has also become the first iPSC-derived therapeutic product in China to enter Phase II clinical trials.

Dr. Cai Meng, CMO of iRegene, stated: "The clinical advancement of NouvNeu001 not only signifies iRegene's global leadership in the field of cell therapy but also reflects our steadfast commitment to bringing innovative solutions to Parkinson's patients. From obtaining dual IND approvals in China and the U.S. to successfully initiating Phase II clinical trials, the iRegene team has consistently adhered to the principles of scientific rigor and efficient execution. Phase I clinical results have shown that NouvNeu001 exhibits breakthrough potential in terms of safety, tolerability, and early efficacy, laying a solid foundation for further clinical development and accelerating the path to commercialization. iRegene will continue to collaborate with top medical institutions both domestically and internationally to provide patients with new treatment options, expediting the realization of dual breakthroughs in clinical and market value."

The successful enrollment of subjects in this Phase II clinical trial demonstrates iRegene's steadfast progress in the development pipeline for cell replacement therapy for Parkinson's disease. NouvNeu001 has become the world’s first iPSC-derived, off-the-shelf Parkinson’s cell therapy product to officially enter Phase II clinical trials, further solidifying iRegene's leading position globally in terms of R&D progress, clinical trial scale, and regulatory recognition for Parkinson’s cell replacement therapies.

Currently, the Phase II clinical trial of NouvNeu001 injection for the treatment of moderate to severe Parkinson's disease has been initiated at multiple research centers in China. Eligible patients with primary moderate to severe Parkinson's disease are now being recruited. All clinical research centers welcome the participation of patient friends!

The list of participating centers is as follows:

1. Beijing Hospital, Ministry of Health

2. Zhongnan Hospital of Wuhan University

3. West China Hospital of Sichuan University

4. The First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)

5. Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

If you are willing to participate in the Phase II clinical trial or are interested in learning more about this study, please scan the QR code below to submit your registration information. Staff from each research center will contact you, and at that time, a specialist doctor will conduct tests and assessments on your physical condition and illness to further confirm whether you meet the enrollment criteria.

References:

1. Public information from iRegene's official WeChat, etc.

DianDian "Share”、“Like" and "In View"，Give me a little recharge~"