礼来(LLY.US)替尔泊肽注射液新适应症在华申报获受理

智通财经
Nov 13, 2025

智通财经APP获悉,11月13日,CDE官网显示,礼来(LLY.US)的葡萄糖依赖性促胰岛素多肽(GIP)和胰高血糖素样肽-1(GLP-1)受体双重激动剂替尔泊肽注射液新适应症上市申请已获得受理。这是该药品在华第三项适应症获批后又一次申报。

2024年5月,替尔泊肽首次在我国获批上市,用于在饮食控制和运动基础上,接受二甲双胍和/或磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病(T2DM)患者。

2024年7月,替尔泊肽又在我国获批一项新适应症:用于在控制饮食和增加运动基础上,体重指数(BMI)符合以下要求的成人的长期体重管理:≥28 kg/m2(肥胖),或≥24 kg/m2(超重)并伴有至少一种体重相关合并症(如:高血压、血脂异常、高血糖、阻塞性睡眠呼吸暂停、心血管疾病等)。

今年6月,替尔泊肽又在华获批第三项适应症:用于治疗成人肥胖患者的中度至重度阻塞性睡眠呼吸暂停(OSA)。

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