S&E bio Co., Ltd., a biotechnology company specializing in exosomal microRNA-based therapies, has received approval from Korea's Ministry of Food and Drug Safety (MFDS) to initiate a Phase 1b clinical trial of its investigational stroke therapy, SNE-101. This is the first exosome-based therapy in Korea to enter clinical trials, marking a major milestone in the country's biopharmaceutical landscape..

S&E生物公司是一家专注于外泌体微小RNA治疗的生物技术公司，已获得韩国食品药品安全部（MFDS）批准，启动其研究性中风治疗药物SNE-101的1b期临床试验。这是韩国首个进入临床试验的外泌体疗法，标志着该国生物制药领域的一个重要里程碑。

S&E bio developed SNE-101 using a proprietary 3D culture system to optimize exosome production from umbilical cord-derived mesenchymal stem cells. The exosomes carry therapeutic microRNAs designed to enhance neuroregeneration.

S&E生物公司利用专有的3D培养系统开发了SNE-101，以优化从脐带来源的间充质干细胞中提取外泌体的生产。这些外泌体携带旨在增强神经再生的治疗性微小RNA。

The approval followed successful resolution of Chemistry, Manufacturing, and Controls (CMC) issues, as well as demonstration of therapeutic efficacy not only in rodent models but also in non-human primates, which better reflect human stroke pathology. Long-term safety was also confirmed.

该批准是在成功解决化学、制造和控制 (CMC) 问题后获得的，同时还在啮齿动物模型以及更能反映人类中风病理的非人灵长类动物中证明了治疗效果。长期安全性也得到了确认。

The Phase 1b trial will evaluate the safety, dose-limiting toxicity, and preliminary efficacy of SNE-101 via intravenous administration. As no approved pharmacological therapies currently exist beyond reperfusion treatments for stroke, SNE-101's potential neuroregenerative, neuroprotective, and anti-inflammatory effects offer new hope for improving recovery in stroke patients..

1b期试验将通过静脉注射评估SNE-101的安全性、剂量限制毒性及初步疗效。由于目前除了再灌注治疗外，尚无获批的中风药物疗法，SNE-101潜在的神经再生、神经保护和抗炎作用为改善中风患者的恢复情况带来了新的希望。

Media Contact:

媒体联系人：

Jae Bok Ban

班在福

COO, Business Development Division, S&E

首运营官，业务发展部，S&E

Source: prnewswire.com

来源：prnewswire.com