{"id":22759,"date":"2025-05-01T09:58:34","date_gmt":"2025-05-01T09:58:34","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/se-bio-receives-koreas-first-approval-for-exosome-based-therapy-clinical-trial\/"},"modified":"2025-05-01T09:58:34","modified_gmt":"2025-05-01T09:58:34","slug":"se-bio-receives-koreas-first-approval-for-exosome-based-therapy-clinical-trial-2","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=22759","title":{"rendered":"S&E bio Receives Korea’s First Approval for Exosome-Based Therapy Clinical Trial"},"content":{"rendered":"\n\n\n
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SEOUL, South Korea<\/span>, May 1, 2025<\/span> \/PRNewswire\/ — S&E bio Co., Ltd.<\/a>, 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.<\/p>\n

\n<\/div>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Media Contact:<\/p>\n

Jae Bok Ban
COO, Business Development Division, S&E bio
jbbanbio@snebio.com<\/a>\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

SEOUL, South Korea<\/span>, May 1, 2025<\/span> \/PRNewswire\/ — S&E bio Co., Ltd.<\/a>, 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.<\/p>\n

\n<\/div>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Media Contact:<\/p>\n

Jae Bok Ban
COO, Business Development Division, S&E bio
jbbanbio@snebio.com<\/a>\u00a0<\/p>\n

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