Zhitong Finance App News, Jiuyuan Gene (02566) issued an announcement. The application for a new drug (IND) for the JY54-2 injection, a new class 1 drug independently developed by the company has been officially accepted by the Drug Evaluation Center (CDE) of the China Drug Administration (CDE) (acceptance numbers: CXHL2601372, CXHL2601373). This IND application covers two indications, namely type 2 diabetes and weight management for people who are obese or overweight. The company plans to conduct a phase I clinical study of JY54-2 injection. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JY54-2 injection in test participants, and to provide a basis for its subsequent clinical development in the above two indications.
JY54-2 injection is a long-acting insulin analog independently developed by the company. This product is a next-generation pH-neutral and stable long-acting amylin analog, and has the potential to develop compound formulations with other metabolic drugs such as GLP-1 products. Natural insulin is secreted by pancreatic beta cells and participates in the regulation of blood sugar and energy metabolism in collaboration with insulin. By simulating the mechanism of action of natural insulin, JY54-2 injection binds to amylin receptors to exert multiple biological effects such as inhibiting glucagon secretion, delaying gastric emptying, and reducing appetite, thereby contributing to blood sugar control and weight management. The company's pre-clinical trial data shows that in many pharmacodynamics and safety studies, JY54-2 injection showed excellent performance in all indicators. Based on its molecular design characteristics and mechanism of action analysis, JY54-2 injection is expected to support long-term dosing regimens and show differentiated clinical application potential in the field of weight management.