Core Viewpoint - Jiuyuan Gene (02566) has received formal acceptance from the National Medical Products Administration (NMPA) for its IND application of the innovative chemical Class 1 drug JY54 injection, aimed at weight management in obese or overweight populations [1] Group 1: Clinical Development - The company plans to conduct Phase I clinical research to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JY54 injection [1] - JY54 injection is a long-acting glucagon-like peptide analog developed by the company, designed to mimic the action of natural glucagon-like peptide [1] Group 2: Mechanism of Action - The drug works by binding to glucagon-like peptide receptors, leading to multiple biological effects such as inhibiting glucagon secretion, delaying gastric emptying, and reducing appetite, which aids in blood sugar control and weight management [1] - Preclinical trial data indicate that JY54 injection has shown excellent performance across various pharmacodynamic and safety studies [1] Group 3: Competitive Advantage - In studies involving combination therapy with existing obesity treatment drugs, JY54 injection has demonstrated significant synergistic potential [1] - The molecular design and mechanism of action suggest that JY54 injection could support long-acting dosing regimens and exhibit differentiated clinical application potential in weight management [1]
九源基因(02566)：JY54注射液IND申请获CDE正式受理