JIUYUAN GENE (02566) announced that the new drug application for its product Jikeqin® has been accepted by the National Medical Products Administration. The product is a biosimilar of semaglutide, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist developed by the group. It was submitted for registration under the biologic product classification 3.3 and is intended for weight management in individuals with obesity or overweight. Jikeqin® works by mimicking the physiological effects of endogenous GLP-1 hormone, promoting insulin secretion, suppressing glucagon release, reducing appetite, and delaying gastric emptying, thereby improving blood glucose control and aiding weight management. In a completed Phase III clinical trial, which was a randomized, open-label, active-controlled, parallel-group equivalency study in subjects with obesity, Jikeqin® demonstrated clinical equivalence to the reference drug in both the primary efficacy endpoint (the percentage change in body weight from baseline after 44 weeks of treatment) and safety profile, showing favorable efficacy and tolerability. Jikeqin® received clinical trial approval from the National Medical Products Administration in January 2024 and completed enrollment for its Phase III clinical study in December 2024. The trial has now concluded, and the application materials have been submitted to the Center for Drug Evaluation for review.