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

May 01, 2025 01:00 AM BST | By Cision
Follow us on Google News: https://kalkinemedia.com/resources/assets/public/images/google-news.webp
 S&E bio Receives Korea's First Approval for Exosome-Based Therapy Clinical Trial
Image source: Kalkine Media

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
[email protected] 


Disclaimer

The content, including but not limited to any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations and video (Content) is a service of Kalkine Media Limited, Company No. 12643132 (“Kalkine Media, we or us”) and is available for personal and non-commercial use only. Kalkine Media is an appointed representative of Kalkine Limited, who is authorized and regulated by the FCA (FRN: 579414). The non-personalized advice given by Kalkine Media through its Content does not in any way endorse or recommend individuals, investment products or services suitable for your personal financial situation. You should discuss your portfolios and the risk tolerance level appropriate for your personal financial situation, with a qualified financial planner and/or adviser. No liability is accepted by Kalkine Media or Kalkine Limited and/or any of its employees/officers, for any investment loss, or any other loss or detriment experienced by you for any investment decision, whether consequent to, or in any way related to this Content, the provision of which is a regulated activity. Kalkine Media does not intend to exclude any liability which is not permitted to be excluded under applicable law or regulation. Some of the Content on this website may be sponsored/non-sponsored, as applicable. However, on the date of publication of any such Content, none of the employees and/or associates of Kalkine Media hold positions in any of the stocks covered by Kalkine Media through its Content. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media.
The content published on Kalkine Media also includes feeds sourced from third-party providers. Kalkine does not assert any ownership rights over the content provided by these third-party sources. The inclusion of such feeds on the Website is for informational purposes only. Kalkine does not guarantee the accuracy, completeness, or reliability of the content obtained from third-party feeds. Furthermore, Kalkine Media shall not be held liable for any errors, omissions, or inaccuracies in the content obtained from third-party feeds, nor for any damages or losses arising from the use of such content. Some of the images/music/video that may be used in the Content are copyright to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures displayed/music or video used in the Content unless stated otherwise. The images/music/video that may be used in the Content are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source wherever it was indicated or was found to be necessary.

This disclaimer is subject to change without notice. Users are advised to review this disclaimer periodically for any updates or modifications.

AI on the Rise: A Look at Top AI Companies and Their Stocks

Recent Articles

Investing Tips

Previous Next