WUHAN, China, Feb. 5, 2024 /PRNewswire/ -- iRegene Therapeutics Co., Ltd (iRegene) recently announced that NouvNeu001, the company's first innovative product, has completed the dosing for its first patient at Beijing Hospital, and the patient has also successfully concluded the observation period.

中国武汉，2024年2月5日/PRNewswire/-iRegene Therapeutics Co.，Ltd（iRegene）最近宣布，该公司的首款创新产品NouvNeu001已在北京医院为其首例患者完成给药，患者也已成功结束观察期。

It is reported that the multicenter, open-label clinical trial (Phase I/II) is meticulously crafted to systematically evaluate the safety, tolerability, and efficacy of stereotactic bilateral intracerebral injection of NouvNeu001 for treating moderate to advanced Parkinson's disease. So far, the Phase I clinical trial has been successfully initiated at both Beijing Hospital (Beijing, PRC) and Zhongnan Hospital (Wuhan, PRC), with dosing completed for its first patient..

据报道，这项多中心开放标签临床试验（I/II期）经过精心设计，旨在系统评估立体定向双侧脑内注射NouvNeu001治疗中晚期帕金森病的安全性，耐受性和有效性。到目前为止，I期临床试验已在北京医院（中国北京）和中南医院（中国武汉）成功启动，第一名患者已完成给药。。

Dr. Cai, CMO of iRegene, said that the completion of the first patient dosing and the successful observation period marks an important milestone in the development of iRegene Therapeutics.

iRegene首席营销官蔡博士表示，第一次患者给药的完成和成功的观察期标志着iRegene疗法发展的一个重要里程碑。

Publicly available information reveals that the NouvNeu001 is a chemically induced human dopaminergic neuron precursor from iPSC, with iRegene Therapeutics wholly owned proprietary. NouvNeu001 is the world's first iPSC-based and chemically induced universal cell therapy product. This product attains high-purity reconstruction and functional optimization of neuronal subtypes via chemical induction.

公开信息显示，NouvNeu001是来自iPSC的化学诱导的人多巴胺能神经元前体，iRegene Therapeutics是全资专有的。NouvNeu001是世界上第一个基于iPSC的化学诱导通用细胞治疗产品。该产品通过化学诱导获得神经元亚型的高纯度重建和功能优化。

Upon transplantation, it establishes connections with the body's existing neurons and augments cellular secretion functions, thereby reinforcing the transplanted cells' ability to improve the original lesion. In this way, it can provide comprehensive therapeutic effects..

移植后，它与身体现有的神经元建立联系，增强细胞分泌功能，从而增强移植细胞改善原始病变的能力。这样，它可以提供全面的治疗效果。。

On August 2, 2023, the National Medical Products Administration (NMPA) of China officially approved the Phase I/II clinical trial of NouvNeu001, designed to assess the safety, tolerability and efficacy in treating moderate to advanced Parkinson's disease. The clinical trial commenced successfully in early January 2024 at Beijing Hospital.

2023年8月2日，中国国家医药产品管理局（NMPA）正式批准了NouvNeu001的I/II期临床试验，旨在评估治疗中晚期帕金森病的安全性，耐受性和有效性。该临床试验于2024年1月初在北京医院成功开始。

More information about this trial is available at clinicaltrials.gov (NCT#06167681)..

有关该试验的更多信息，请访问clinicaltrials.gov（NCT#06167681）。。

iRegene Therapeutics, the pioneering biotech company behind NouvNeu001, stands as one of the global frontrunners in harnessing 'AI + chemical induction' for cell-specific functional remodeling. Leveraging its unique 'AI + chemical induction' platform, iRegene Therapeutics has developed an extensive pipeline of universal iPSC-derived products.

iRegene Therapeutics是NouvNeu001背后的领先生物技术公司，是利用“AI+化学诱导”进行细胞特异性功能重塑的全球领先者之一。利用其独特的“AI+化学诱导”平台，iRegene Therapeutics开发了广泛的通用iPSC衍生产品管道。

The company is dedicated to advancing universal cell therapy products and introducing novel treatment alternatives for traditionally 'incurable' neurodegenerative diseases, including Parkinson's disease and blindness..

该公司致力于推进通用细胞疗法产品，并为传统上“无法治愈”的神经退行性疾病（包括帕金森氏病和失明）引入新的治疗替代品。。

About NouvNeu001

关于NouvNeu001

NouvNeu001 is a chemically induced human dopaminergic neuron precursor from iPSC, with iRegene Therapeutics wholly owned proprietary. NouvNeu001 is the world's first iPSC-based and chemically induced universal cell therapy product. On August 2, 2023, the National Medical Products Administration (NMPA) of China officially approved the Phase I/II clinical trial of NouvNeu001, designed to assess the safety, tolerability and efficacy in treating moderate to advanced Parkinson's disease.

NouvNeu001是来自iPSC的化学诱导的人多巴胺能神经元前体，具有iRegene Therapeutics的全资专有权。NouvNeu001是世界上第一个基于iPSC的化学诱导通用细胞治疗产品。2023年8月2日，中国国家医药产品管理局（NMPA）正式批准了NouvNeu001的I/II期临床试验，旨在评估治疗中晚期帕金森病的安全性，耐受性和有效性。

The clinical trial commenced successfully in early January 2024 at Beijing Hospital. More information about this trial is available at clinicaltrials.gov (NCT#06167681)..

该临床试验于2024年1月初在北京医院成功开始。有关该试验的更多信息，请访问clinicaltrials.gov（NCT#06167681）。。

About iRegene Therapeutics

关于iRegene Therapeutics

iRegene Therapeutics, is the earliest biotech company in the world focusing on accurately reprograming cell fate and functions by chemicals. Leveraging its unique 'AI + chemical induction' platform, iRegene Therapeutics has developed an extensive pipeline of universal iPSC-derived products. The company is dedicated to advancing universal cell therapy products and introducing novel treatment alternatives for 'incurable' neurodegenerative diseases, including Parkinson's disease and blindness..

iRegene Therapeutics是世界上最早的生物技术公司，专注于通过化学物质准确地重新编程细胞命运和功能。利用其独特的“AI+化学诱导”平台，iRegene Therapeutics开发了广泛的通用iPSC衍生产品管道。该公司致力于推进通用细胞疗法产品，并为“无法治愈”的神经退行性疾病（包括帕金森氏病和失明）引入新的治疗替代品。。

SOURCE iRegene Therapeutics Co., Ltd

SOURCE易瑞金治疗有限公司