「睿健医药」B轮次融资累计超3亿，帕金森干细胞疗法拿下美国FDA快速通道认定｜36氪首发

Core Insights - Rui Jian Yi Lian Pharmaceutical Technology (Chengdu) Co., Ltd. has completed a new B+ round of financing, with funds aimed at accelerating clinical development of its Parkinson's disease treatment products NouvNeu001/NouvNeu003 and ophthalmic treatment product NouvSight001 [1][2] - The total amount raised in the B round has exceeded 300 million yuan, indicating strong investor confidence and interest in the iPSC drug development sector [1][5] - NouvNeu001 has received Fast Track Designation from the FDA, which may expedite its clinical application and commercialization [2][4] Company Overview - Founded in 2017, Rui Jian Yi Lian focuses on the development of small molecule chemical transcription regulation-induced pluripotent stem cell (iPSC) products [1] - The company's core product, NouvNeu001, is a chemically induced functional human-derived dopaminergic neuron precursor cell, currently in multi-center Phase II clinical trials [1][2] Clinical Development - NouvNeu001 has shown good safety and tolerability in Phase I trials, with long-term survival of cells in patients without immunosuppressants [1][2] - NouvNeu003, targeting early-onset Parkinson's disease in patients under 50, has completed Phase I trials with preliminary validation of safety and efficacy [2] Regulatory Milestones - NouvSight001 received Orphan Drug Designation from the FDA in March 2024, aimed at treating retinitis pigmentosa [3] - The Fast Track Designation for NouvNeu001 allows for targeted guidance from the FDA on clinical trial design and data requirements, potentially accelerating its market entry [2] Investor Perspectives - The CEO of Rui Jian Yi Lian expressed gratitude for investor support, emphasizing the goal of achieving breakthroughs in international major disease fields [4] - Investors highlighted the company's leading position in iPSC drug development and the promising clinical data of NouvNeu001, which is seen as a potential global first in iPSC-derived cell therapy [4][5]