Core Viewpoint - Jiuyuan Gene (02566) has announced that the listing application for its product, Jikeqin, has been accepted 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 - Phase III clinical trials have been conducted with Jikeqin in obese subjects, featuring a randomized, open-label, positive control, parallel design to assess clinical equivalence [1] - Results from the trials 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 - The company 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 for market listing has been submitted to the National Drug Review Center for evaluation [1]
九源基因：吉可亲 上市申请获国家药品监督管理局受理