Core Viewpoint - Jiuyuan Gene (02566) has received acceptance for the listing application of its product, Jikeqin®, by the National Medical Products Administration of China, marking a significant step in the development of its long-acting GLP-1 receptor agonist, semaglutide biosimilar [1] Group 1: Product Development - Jikeqin® is developed as a biosimilar of semaglutide, classified under biological drug registration category 3.3, intended for weight management in obese or overweight populations [1] - The product mimics the physiological effects of endogenous GLP-1 hormone, promoting insulin secretion, inhibiting glucagon release, suppressing appetite, and delaying gastric emptying to improve blood sugar control and facilitate weight management [1] Group 2: Clinical Trials - A Phase III clinical trial has been conducted, featuring a randomized, open-label, positive-controlled, parallel design to assess the clinical equivalence of Jikeqin® in obese subjects [1] - Results from the trial indicate that Jikeqin® demonstrates clinical equivalence to the reference drug in terms of primary efficacy indicators (weight change rate after 44 weeks of treatment) and safety, showcasing good efficacy and tolerability [1] Group 3: Regulatory Milestones - Jikeqin® received the drug clinical trial approval notice from the National Medical Products Administration in January 2024 and completed the enrollment of all subjects for the Phase III clinical study by December 2024 [1] - The application materials for the listing have been submitted to the National Drug Review Center for evaluation [1]
九源基因(02566)：吉可亲®上市申请获国家药品监督管理局受理