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SEOUL, South Korea, May 1, 2025 /PRNewswire/ -- 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 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.
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.
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.
Media Contact:
Jae Bok Ban
COO, Business Development Division, S&E bio
jbbanbio@snebio.com
source: S&E bio Co., Ltd.
【說說心理話】陳敏兒經歷丈夫突然病逝，成立「幸福生活協會」，幫助照顧者。舉辦按摩工作坊，讓癌末病人都有幸福的感覺► 即睇
