智通财经APP讯，九源基因(02566)发布公告，集团开发的吉可亲®的上市申请已获中国国家药监局受理。
该产品为集团研发的长效胰高血糖素样肽-1(GLP-1)受体激动剂司美格鲁肽生物类似药，按照生物药品注册分类3.3类申报，拟用于肥胖或超重人群的体重管理。吉可亲®通过模拟内源性GLP-1激素的生理作用，发挥促进胰岛素分泌、抑制胰高血糖素释放、抑制食欲及延缓胃排空等多重机制，从而改善血糖控制并实现体重管理。在已开展的Ⅲ期临床试验中，吉可亲®在肥胖症受试者中进行随机、开放、阳性对照、平行设计的临床等效性研究。研究结果显示，其在主要疗效指标(治疗44周后体重较基线的变化率)及安全性方面与参照药具有临床等效性，展现出良好的有效性和耐受性。
吉可亲®于2024年1月获得国家药品监督管理局签发的药物临床试验批准通知书，并于2024年12月完成Ⅲ期临床研究全部受试者入组，目前已完成试验，上市申请相关申报资料已递交国家药品审评中心进行审评。
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