JIUYUAN GENE (02566): JiKeQin's listing application has been accepted by the National Medical Products Administration.

JIUYUAN GENE (02566) announced that the listing application for Jikeqin, developed by the group, has been accepted by the China National Medical Products Administration. This product is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide biosimilar drug developed by the group. It is classified as a Type 3.3 biological drug for registration and is intended for weight management in obese or overweight populations. Jikeqin mimics the physiological effects of endogenous GLP-1 hormones, promoting insulin secretion, inhibiting glucagon release, suppressing appetite, delaying gastric emptying, and improving blood sugar control for weight management. In Phase III clinical trials, Jikeqin conducted a randomized, open-label, positive-controlled, parallel-designed clinical equivalency study among obese subjects. The study results show that it is clinically equivalent to the reference drug in terms of major efficacy indicators (changes in weight compared to baseline after 44 weeks of treatment) and safety, demonstrating good effectiveness and tolerability. Jikeqin obtained the drug clinical trial approval notification issued by the National Medical Products Administration in January 2024 and completed the enrollment of all subjects in Phase III clinical research in December 2024. The trial has been completed, and the application for listing has been submitted to the National Drug Evaluation Center for review.