Ruijian Medicine Consolidates Its Global First-Mover Status with Successful Launch of Phase II Clinical Trial for NouvNeu001 Injection in Parkinson’s Disease

This is another milestone event announced by iRegene after it pioneered the world's first clinical-stage universal iPSC-derived cell therapy product for Parkinson’s disease.Centered on Parkinson's disease, an "irreversible condition," the universal cell therapy developed by iRegene has significantly outpaced similar competitors in terms of clinical progress and scale.

With the acceleration of population aging, the incidence of Parkinson's disease continues to rise. According to data from the World Health Organization, the global incidence of Parkinson's disease has doubled in the past 25 years, with more than 8.5 million people worldwide suffering from the disease in 2019. Central nervous system disorders, including Parkinson's disease, have become a leading cause of disability globally.

Although the issue of Parkinson's disease is becoming increasingly severe with the intensification of aging, there are still no effective drugs on the market that can reverse the degeneration process of brain nerve cells in patients with this disease. Facing this clinical reality, iRegene, as a global leader in the iPSC Parkinson’s cell therapy field, initiated the clinical work for NouvNeu001, its first-in-class Parkinson’s drug, in August 2023. This is also the world’s first off-the-shelf iPSC-derived cell therapy product to enter the clinical stage in the Parkinson’s field.

Currently, NouvNeu001 has achieved "dual submissions and dual approvals" for clinical trials in both China and the United States. Based on this, iRegene has become the world’s first Parkinson's cell drug development company to complete and receive approval for IND dual submissions in both China and the U.S.，iRegene is indisputably the global leader in the research and development progress of cell replacement therapy for Parkinson's disease, as well as in the scale of clinical trials and regulatory recognition.

The Successful Holding of iRegene's NouvNeu001 Injection I/II Clinical Trial Investigator Meeting and Phase II Launch Event in Wuhan for the Treatment of Moderate to Severe Parkinson’s Disease Marks a Breakthrough for This Novel Drug and Another Significant Advance in the Field of Parkinson’s Treatment.

According to the company, the Phase II study has brought together a top expert team in the field of Parkinson's disease treatment in China, including Professor Chen Haibo's team from Beijing Hospital, Professor Shang Huifang's team from West China Hospital of Sichuan University, Professor Xiong Nanxiang's team from Zhongnan Hospital of Wuhan University, Professor Niu Chaoshi's team from the First Affiliated Hospital of the University of Science and Technology of China, and Professor Xiong Nian's team from Union Hospital affiliated with Huazhong University of Science and Technology. Dr. Wei Jun, CEO of iRegene, Dr. Cai Meng, CMO, and the core R&D team, as well as representatives from CRO, SMO, and other project partners attended the meeting. The participants reviewed the Phase I clinical trial together and had in-depth discussions on the Phase II clinical research plan and key evaluation indicators, laying a solid foundation for the smooth progress of the Phase II clinical trial and confirmatory clinical trials of NouvNeu001 injection for the treatment of moderate to severe Parkinson's disease.

At the beginning of the conference, Professor Chen Haibo from Beijing Hospital, the principal investigator of the "Phase I/II Clinical Trial of NouvNeu001 Injection for the Treatment of Moderate to Severe Parkinson's Disease," delivered the opening remarks. Subsequently, Dr. Wei Jun, CEO of iRegene, reported to the attending experts on the product development process and preclinical data. Professor Chen Haibo further reviewed the Phase I clinical trial, summarizing the Phase I clinical trial of NouvNeu001 Injection for the treatment of moderate to severe Parkinson's disease. This study was a single-arm, multi-center, open-label clinical trial. Professor Chen systematically analyzed the primary safety and tolerability endpoints of the Phase I clinical trial and revealed a significant trend of efficacy improvement in the Phase I clinical trial. After receiving the transplant, subjects showed a marked trend of improvement in both behavioral and non-behavioral aspects. Professor Xiong Nanxiang from Zhongnan Hospital of Wuhan University introduced the exploratory work and experience summary in the neurosurgical field during the Phase I clinical trial of NouvNeu001 Injection for the treatment of moderate to severe Parkinson's disease. Dr. Wang Qiao from Beijing Hospital discussed the surgical delivery route and postoperative reconstruction. Director Ma Xinxin from Beijing Hospital shared the key evaluation indicators of this study. Finally, all participating teams conducted systematic discussions on clinical trial strategies, evaluation indicators, and delivery optimization strategies. Experts such as Professor Shang Huifang from West China Hospital of Sichuan University and Professor Niu Chaoshi from the First Affiliated Hospital of the University of Science and Technology of China provided highly constructive opinions and suggestions on various aspects of the Phase II clinical trial. The open and pragmatic discussions among the attending experts laid a solid foundation for the smooth progress of the Phase II clinical trial and confirmatory clinical trials of NouvNeu001 Injection for the treatment of moderate to severe Parkinson's disease.