iRegene Therapeutics Submits IPO Prospectus Highlighting Global First-in-Class Chemically Induced iPSC Therapy for Parkinson’s Disease
“Uncurable and irreversible.” More than 200 years after British physician James Parkinson first described the disease in 1817, Parkinson’s disease remains a de facto incurable “terminal illness.” However, empowered by cutting-edge technologies, high-tech pharmaceutical companies in China are bringing new possibilities for reversing the course of this disease.
On August 2, the National Medical Products Administration (NMPA) officially approved the Investigational New Drug (IND) application for NouvNeu001, a novel Parkinson’s disease drug developed by Wuhan Ruijian Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Ruijian Pharmaceutical”). This marks the first globally recognized chemically induced universal cell therapy product for Parkinson’s disease to enter clinical trials.
Unlike conventional pharmacological or surgical interventions, NouvNeu001 is a universal cell therapy product developed with a focus on addressing clinical needs. It leverages small molecules to achieve precise modulation of cellular functions, thereby truly meeting unmet clinical demands. NouvNeu001 utilizes compound-mediated regulation to drive high-purity differentiation into specific neuronal subtypes, establish connections with endogenous neurons, and enhance cellular secretory function. These mechanisms collectively augment the therapeutic impact of transplanted cells on existing lesions, resulting in comprehensive treatment efficacy.
The successful development of the NouvNeu001 product relies on the pure chemical induction system established by Regend Therapeutics, a novel cell functional reprogramming platform that is more efficient, safer, and cost-effective, making it better suited for large-scale industrial production. Since commencing formal operations over five years ago, Regend Therapeutics has built an intellectual property portfolio covering novel structural induction compounds, basal media, manufacturing processes, and quality systems.
Dr. Wei Jun, Co-founder and CEO of Ruijian Medicine, stated that the approval of NouvNeu001 for clinical trials marks a phased breakthrough in Ruijian’s “end-in-mind” R&D philosophy, further strengthening the team’s determination to “work together in unity, strive for excellence, discern the significant from the subtle, and wisely build the future,” with a commitment to delivering truly disease-modifying therapies that can reverse disease progression and are accessible to all patients.
As the aging population accelerates, the number of Parkinson’s disease patients is also experiencing rapid growth.
Professor Wang Zhenfu, Director of the Department of Geriatric Neurology at the Chinese PLA General Hospital, cited data indicating that the prevalence of Parkinson’s disease among individuals aged 65 and older in China is 1.7%. According to the 2019 population census results released by the National Health Commission of China, there are 217 million people aged 65 and older in the country. Based on these figures, it is estimated that the number of Parkinson’s disease patients in China approaches 3.7 million. More importantly, there is a growing trend toward younger onset of Parkinson’s disease among patients in China.
Given the vast patient population, current treatment options remain limited. Existing clinical approaches—including pharmacological therapies represented by levodopa, physical interventions such as deep brain stimulation (DBS), and other adjunctive treatments—fail to address the loss of functional neurons in the patients’ brains. Consequently, these therapies are merely compensatory and are plagued by significant side effects. Patients often experience dyskinesia or the “on-off” phenomenon after medication administration, with a pronounced wearing-off effect.
To address this urgent clinical unmet need, international efforts to explore the potential of cell replacement therapy for Parkinson’s disease have been underway since the 1990s. However, it was not until January 2021 that the FDA approved the first Investigational New Drug (IND) application for a cell replacement therapy—BlueRock’s embryonic stem cell-derived product, MSK-DA01. On June 28, 2023, it was announced that this product had completed its Phase I clinical safety trial with positive results.
NouvNeu001, which has recently received IND approval, is a breakthrough cell therapy product with fully independent intellectual property rights owned by Ruijian Medicine. Results from completed pharmacodynamic and safety studies indicate that animal models of various diseases treated with NouvNeu001 exhibited substantial recovery in behavioral functions and significant improvements in multiple physiological and biochemical indices within four weeks post-administration. In contrast, BlueRock’s comparable therapeutic agent requires a minimum of twelve weeks post-administration to demonstrate efficacy. The international competitive advantage of Ruijian’s NouvNeu001 stems from Ruijian’s pioneering “chemical induction platform.”
This breakthrough technological advantage stems from the team’s pioneering R&D approach. Professor Luo Yonglun, Chief Scientist at Ruijian Medicine and Researcher at the European Molecular Biology Laboratory – Denmark Center for Translational Neuroscience, stated that since its inception, Ruijian Medicine’s scientific team has integrated interdisciplinary fields—including developmental biology, chemistry, omics analysis, and computational topology of interaction networks—and solidified its “AI + chemically induced” platform. By identifying precise “chemical small-molecule switches” to initiate standardized regulatory processes in each cell, the company has achieved refined multifunctional reprogramming of cells, thereby simultaneously addressing multiple challenges in the industrial manufacturing of cell therapy drugs, including efficiency, safety, and cost.
“Ruijian’s unique ‘AI + chemical induction’ platform is not only poised to deliver NouvNeu001, a breakthrough therapeutic product for Parkinson’s disease, but its scalability is also widely recognized. The company has already built a pipeline of multiple new modalities, strategically positioning itself to address complex diseases and expected to bring more breakthrough products to the market,” stated Professor Luo Yonglun.
Professor Luo Yonglun, Chief Scientist at Ruijian Pharma
The successful approval of NouvNeu001 was critically driven by the extensive industry experience of Dr. Cai Meng, Chief Manufacturing Officer (CMO) of Ruijian Medicine, and Mr. Ren Xiang, Chief Quality Officer (CQO). Dr. Cai stated that for a company to consistently deliver high-quality medicines to the market, a versatile team and a cohesive corporate culture are paramount, with every incremental progress being the result of collaborative teamwork. Adhering to its motto of “Working Together in Unity, Striving for Excellence, Perceiving the Significant from the Subtle, and Wisely Building the Future,” Ruijian Medicine’s founding team continues to recruit multidisciplinary talents who possess an international perspective and share its values, with PRACTICE serving as the company’s core value system.
To date, Ruijian Pharmaceuticals has assembled an international team with professional and academic backgrounds in the United Kingdom, the United States, Germany, Australia, and Japan. Team members possess over 15 years of proven domestic and international experience in biopharmaceutical scientific innovation, translational medicine and clinical development, biopharmaceutical regulatory affairs, operational management at multinational pharmaceutical companies, and capital operations. Currently, beyond mainland China, the Ruijian Pharmaceuticals team has established a presence in key global regions, including Europe, the Americas, and the Asia-Pacific.
Mr. Emmanuel Montet, Executive Vice President of Ruijian Pharmaceuticals, previously served as Head of Industrial Control at GSK Biologicals, Deputy Director of Audit at Sanofi-Aventis, and Vice President for Asia-Pacific at IPSEN before joining Ruijian full-time. He brings over 20 years of experience in international business and market access for pharmaceuticals. Mr. Montet stated that a truly internationally competitive innovative drug must meet genuine clinical needs and demonstrate significant advantages in efficacy, safety, or cost. The Ruijian team not only comprises outstanding scientists but also possesses keen market insight; driving R&D through market demand is a highly prudent strategy. Mr. Montet believes that the Ruijian team demonstrates the robust capabilities expected of an international innovative pharmaceutical company. Beyond technological innovation, the team’s patient-centric philosophy, comprehensive management expertise, and strict compliance ensure the company’s sustained long-term growth.
Emmanuel Montet, Executive Vice President of Ruijian Pharmaceutical
As global talent continues to flow in, Ruijian Medicine has also launched its international expansion. The company’s innovation center in Denmark, operational office in Singapore, and business office in the United States became operational in 2022. Additionally, Ruijian Medicine has established a joint laboratory with Danaher Corporation to jointly advance the research, development, and clinical application of globally innovative AI platform-based chemically induced cell therapies. Furthermore, NouvNeu001, which recently received IND approval, has also submitted IND applications in Australia, the United States, and other regions.
To prepare for global clinical trials, Ruijian Medicine has also established a large-scale industrial production base, achieving autonomous control over its drug production supply chain. According to reports, the company has built B+A grade production facilities compliant with cGMP standards, along with an industrial production and R&D base spanning over 10,000 square meters. This infrastructure provides sufficient capacity for allogeneic cell therapies to meet global market demand, while also supporting logistics and distribution capabilities across China, the United States, and Australia.