Hangzhou Jiuyuan Genetic Biopharmaceutical Co., Ltd. (2566) announced that the Investigational New Drug application for its self-developed Class 1 chemical innovative drug, JY54 Injection, has been formally accepted by the Center for Drug Evaluation of the National Medical Products Administration. The company intends to conduct a Phase I clinical study in obese or overweight populations to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JY54 Injection.

JY54 Injection is a long-acting amylin analog designed to mimic natural amylin, which is secreted by pancreatic β-cells and works in conjunction with insulin to regulate glucose and energy metabolism. Preclinical trial data indicate that JY54 Injection demonstrates favorable performance across pharmacodynamics and safety indicators. The company also points to its potential synergistic benefits when combined with already marketed weight management treatments, citing its long-acting design and mechanism of action.

According to the announcement, shareholders and potential investors are urged to exercise caution when trading the company’s shares.