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「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
3 6 Ke· 2025-09-04 00:06
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]
帕金森干细胞疗法正式启动II期临床,「睿健医药」获超2亿元融资|早起看早期
36氪· 2025-04-11 14:57
Core Viewpoint - RuiJian Pharmaceutical has recently completed over 100 million yuan in Series B+ financing, led by Fengchuan Capital, to accelerate clinical trials and product development for its core pipeline targeting Parkinson's disease [4][5]. Financing and Growth - The company has raised over 200 million yuan in total from two rounds of Series B financing [5]. - RuiJian Pharmaceutical focuses on the development of small molecule chemical transcription regulation-induced pluripotent stem cell (iPSC) products since its establishment in 2017 [5]. Product Development and Clinical Trials - The core product NouvNeu001, aimed at treating Parkinson's disease, has recently entered Phase II clinical trials [5][6]. - Initial Phase I clinical results showed significant clinical improvement in motor functions and non-motor symptoms in patients after six months of cell transplantation [7]. - The product has demonstrated long-term efficacy, with some patients showing stable improvements in behavior and mobility beyond 60 weeks post-treatment [7]. Future Prospects and Regulatory Approvals - RuiJian Pharmaceutical is also developing NouvNeu003, targeting early-onset Parkinson's patients under 50, which has received approval for Phase I clinical trials [8]. - The company has made progress in overseas clinical research, with NouvNeu001's IND application approved in the U.S. and expected to start Phase I trials soon [8]. Market Position and Investor Insights - The founder and CEO, Dr. Wei Jun, emphasized the company's commitment to addressing clinical needs and providing innovative therapies that can potentially reverse disease progression [9]. - Investors express confidence in RuiJian Pharmaceutical's technology and its potential to become a leading player in the iPSC field, highlighting the significant social and commercial value of its products [10].