Jiuyuan Gene (02566): JY54 injection IND application officially accepted by CDE

Jiuyuan Gene (02566) announced that the company has submitted an Investigational New Drug (IND) application for its chemically class 1 innovative drug JY54 injection, which has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company plans to conduct Phase I clinical research on JY54 injection for weight management in obese or overweight populations. The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JY54 injection in subjects. JY54 injection is a long-acting insulin analog developed independently by the company. Natural insulin is secreted by pancreatic beta cells and plays a role in regulating blood glucose and energy metabolism. JY54 injection simulates the action mechanism of natural insulin by binding to insulin receptors, inhibiting glucagon secretion, delaying gastric emptying, reducing appetite, and exerting multiple biological effects that help in blood sugar control and weight management. Preclinical trial data from the company have shown excellent performance in various pharmacological and safety studies. In addition, in studies on combined use with existing obesity treatment drugs, JY54 injection has demonstrated significant synergistic potential. Based on its molecular design and mechanism of action, JY54 injection is expected to support a long-acting dosing regimen and show differentiated clinical application potential in the field of weight management.