PR Newswire - S&E bio Receives Korea's First Approval for Exosome-Based Therapy Clinical Trial

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