Sciwind’s Second Marketing Authorization Application of Ecnoglutide for Chronic Weight Management Has Been Accepted by the NMPA of China
December 12, 2024. Sciwind Biosciences announces that the Marketing Authorization Application for ecnoglutide injection (Class I New Drug) has been accepted by the National Medical products Administration (NMPA) of China, for chronic weight management in adults with obesity or overweight in combination with a reduced calorie diet and increased physical activity. As previously announced, the Marketing Authorization Application of ecnoglutide for the treatment of adults with type 2 diabetes was accepted by the NMPA in November 2024.
About Ecnoglutide Injection
Ecnoglutide injection, discovered and developed by Sciwind Biosciences, is a first-in-class cAMP signaling biased, long acting glucagon-like peptide-1 receptor agonist (GLP-1RA) to successfully complete phase III clinical trials in support of Marketing Authorization applications for the treatment of adults with type 2 diabetes and adults with obesity or overweight in China. Part of the phase III results have been presented at the Scientific Sessions of the American Diabetes Association (ADA 2024) and the European Association for the Study of Diabetes (EASD 2024). Phase III trials of ecnoglutide have demonstrated robust efficacy in the treatment of type 2 diabetes and obesity, as well as favorable safety and tolerability.
About Sciwind Biosciences
Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease. Its product pipeline consists of potentially first-in-class and best-in-class drug candidates, including the long-acting GLP-1 peptide ecnoglutide, oral GLP-1 peptide XW004 and oral small molecule GLP1RA XW014. Sciwind Biosciences has developed multiple proprietary technologies, including oral peptide and inhaled protein therapeutic delivery plaƞorms and identified a series of drug candidates based on these core plaƞorm technologies. For more information, visit www.sciwindbio.com.
References
Guo, W. et al. Discovery of ecnoglutide – a novel. Long-acting, cAMP-biased glucagon-like peptide-1 (GLP-1) analog. Mol. Metab. 75,101762 (2023).
Zhu, D. et al. Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial. Nat. Commun. 15,9408(2024)
Disclaimer
This news release is intended to share the registration status of ecnoglutide, to provide reference information to healthcare professionals. It is not an advertisement.
Sciwind Biosciences does not endorse the use of any unapproved product and/or indication.