JIUYUAN GENE (02566) has announced that the Investigational New Drug (IND) application for its self-developed Class 1 chemical innovative drug, JY54 injection, has been formally accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company plans to initiate a Phase I clinical study of JY54 injection for weight management in individuals with obesity or who are overweight. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JY54 injection in subjects. JY54 injection is a long-acting amylin analog developed independently by the company. Natural amylin is secreted by pancreatic beta cells and works in coordination with insulin to regulate blood glucose and energy metabolism. By mimicking the mechanism of action of natural amylin and binding to the amylin receptor, JY54 injection exerts multiple biological effects, including inhibiting glucagon secretion, delaying gastric emptying, and reducing appetite, thereby contributing to blood glucose control and weight management. The company's pre-clinical trial data indicate that JY54 injection demonstrated excellent performance across various metrics in multiple pharmacodynamic and safety studies. Furthermore, in studies investigating its combined use with marketed obesity treatments, JY54 injection showed significant potential for drug synergy. Based on its molecular design characteristics and mechanism of action analysis, JY54 injection is expected to support a long-acting dosing regimen and exhibit differentiated clinical application potential in the field of weight management.