智通财经APP讯，九源基因(02566)发布公告，公司自主开发的化学1类创新药JY54 注射液新药临床试验(IND)申请，已获国家药品监督管理局(NMPA)药品审评中心(CDE)正式受理。本公司计划开展JY54注射液用于肥胖或超重人群体重管理的Ⅰ期临床研究，该研究旨在评价JY54注射液在受试者中的安全性、耐受性、药代动力学和药效动力学。
JY54注射液是公司自主研发的一款长效胰淀素类似物。天然胰淀素由胰岛 β 细胞分泌，与胰岛素协同参与血糖及能量代谢调控。JY54注射液通过模拟天然胰淀素的作用机制，与胰淀素受体结合，发挥抑制胰高血糖素分泌、延缓胃排空及降低食欲等多重生物学效应，从而有助于血糖控制及体重管理。公司临床前试验数据显示，在多项药效学和安全性研究中，JY54注射液在各项指标上均显示出优异表现。此外，在与已上市肥胖治疗药物的联合应用研究中，JY54注射液展现出显著的药物协同潜力。基于其分子设计特点及作用机制分析，JY54注射液有望支持长效给药方案，并在体重管理领域展现差异化的临床应用潜力。
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