九源基因:JY54注射液IND申请获CDE正式受理

Core Viewpoint - Jiuyuan Gene (02566) has received formal acceptance from the National Medical Products Administration (NMPA) for the clinical trial application of its self-developed innovative drug JY54 injection, aimed at weight management in obese or overweight populations [1] Group 1: Drug Development - JY54 injection is a long-acting glucagon-like peptide-1 (GLP-1) analog developed by the company [1] - The drug mimics the action of natural glucagon-like peptide-1, binding to GLP-1 receptors to exert multiple biological effects, including inhibition of glucagon secretion, delayed gastric emptying, and appetite reduction [1] - Preclinical trial data indicates that JY54 injection has shown excellent performance across various pharmacodynamic and safety studies [1] Group 2: Clinical Research - The company plans to conduct Phase I clinical research to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JY54 injection in subjects [1] - JY54 injection has demonstrated significant drug synergy potential in studies involving combination with existing obesity treatment medications [1] Group 3: Market Potential - Based on its molecular design characteristics and mechanism of action, JY54 injection is expected to support long-acting dosing regimens and exhibit differentiated clinical application potential in the field of weight management [1]