Core Viewpoint - Jiuyuan Gene (02566.HK) has announced that the application for the market launch of its product, Jikeqin®, has been accepted by the National Medical Products Administration of the People's Republic of China [1] Group 1: Product Development - Jikeqin® is a long-acting GLP-1 receptor agonist, a biosimilar to semaglutide, aimed at weight management for obese or overweight individuals [1] - The product is classified under Category 3.3 for biological drug registration and mimics the physiological effects of endogenous GLP-1 hormone [1] Group 2: Mechanism of Action - Jikeqin® promotes insulin secretion, inhibits glucagon release, suppresses appetite, and delays gastric emptying, thereby improving blood glucose control and facilitating weight management [1] Group 3: Clinical Trials - Phase III clinical trials have shown that Jikeqin® demonstrates clinical equivalence in primary efficacy indicators and safety compared to the reference drug [1] - The trials involved a randomized, open-label, positive-controlled, parallel design and were conducted on obese subjects [1] Group 4: Regulatory Milestones - The drug received a clinical trial approval notice from the National Medical Products Administration in January 2024 and completed the enrollment of all Phase III clinical trial subjects by December 2024 [1] - The application for market launch has been submitted to the National Drug Review Center for evaluation [1]
九源基因(02566.HK)：吉可亲®上市申请获国家药监局受理