礼来(LLY.US)1类新药imlunestrant片在中国上市申请获受理 治疗乳腺癌
智通财经APP获悉，今日（4月8日），中国国家药监局药品审评中心（CDE）官网最新公示，礼来(LLY.US)（Eli Lilly and Company）申报的1类新药imlunestrant片上市申请获得受理。公开资料显示，这是礼来在研的口服选择性雌激素受体降解剂（SERD）。该产品治疗雌激素受体阳性（ER+）、人表皮生长因子受体2阴性（HER2-）晚期乳腺癌患者的3期临床研究此前已经取得积极结果。
截图来源：CDE官网
近年来，针对ER的蛋白降解疗法开始成为重要的乳腺癌治疗模式。选择性雌激素受体降解剂（SERD）与ER结合后通过引发ER的结构变化，使得细胞里的E3泛素连接酶能更好地识别ER，并在其表面打上“垃圾”标签，最终使ER被送到细胞的蛋白酶体中降解。
Imlunestrant正是一款可穿越血脑屏障的小分子SERD药物。它的设计目标是无论ESR1突变状态如何，均能够在整个给药期间持续抑制ER靶点的活性。ESR1突变是乳腺癌患者内分泌治疗耐药的主要变异形式，在晚期乳腺癌患者，尤其是曾接受芳香化酶抑制剂治疗的患者中发生率高达20%~50%。
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