礼来(LLY.US)申报的1类新药LY3473329片拟纳入突破性治疗品种

智通财经
Jun 13, 2025

智通财经APP获悉,6月13日,CDE官网显示,礼来(LLY.US)申报的1类新药LY3473329片拟纳入突破性治疗品种,用于治疗伴有Lp(a)水平升高且确诊心血管疾病或发生首次心血管事件风险升高的成人患者。LY3473329(莫伐倍林,Muvalaplin)是礼来开发的一种每日一次口服的Lp(a)选择性抑制剂,可通过结合Apo(a)的KIV7-8,阻断Apo(a)和ApoB之间的初始非共价相互作用,并抑制随后二硫键的形成,最终阻止Lp(a)颗粒的组装,没有影响Lp(a)的表达。

2024年11月,礼来公布了II期临床研究(NCT05563246)结果。数据显示,LY3473329(10mg、60mg和240mg)各剂量组均显著降低了Lp(a)浓度,且呈现明显的剂量依赖性。LY3473329作为靶向Lp(a)的口服降脂药,与传统降脂药相比,LY3473329的口服给药方式打破了注射剂型的不便,大大提高了患者的用药依从性,让降脂治疗更加便捷高效。

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