港股异动 | 四环医药(00460)早盘拉升逾7% 吡洛西利片新增适应症新药上市申请获NMPA正式受理

智通财经网
Jun 13, 2025

智通财经APP获悉,四环医药(00460)早盘拉升逾7%,截至发稿,涨7.76%,报1.25港元,成交额6441.77万港元。

消息面上,四环医药发布公告,本集团旗下非全资附属公司轩竹生物科技股份有限公司(轩竹生物)自主研发的1类创新药吡洛西利片(商品名:轩悦宁®)(该产品)新增适应症的新药上市申请(NDA)获得中国国家药品监督管理局(NMPA)受理,具体适应症为:与芳香化酶抑制剂联用作为激素受体阳性(HR+)、人表皮生长因数受体2阴性(HER2-)(HR+/HER2-)晚期乳腺癌患者的初始内分泌治疗,以及经他莫昔芬或托瑞米芬辅助治疗后进展患者的后续治疗。是该产品申报NDA的第3项适应症。

吡洛西利是轩竹生物自主研发的一款CDK4/6(细胞周期依赖性激酶4和6)抑 制剂,凭藉其独特的CDK2/4/6/9多靶点协同作用机制,在强效抑制肿瘤细胞增殖的同时,显著降低传统CDK4/6抑制剂常见的3/4级中性粒细胞减少等血液学毒性,提升患者治疗耐受性。此前已获批联合氟维司群二线内分泌治疗及单药后线治疗两大适应症,未来该产品将覆盖HR+/HER2-晚期乳腺癌患者的一线、二线、后线治疗的全部人群,将进一步完善乳腺癌全程管理布局,为国内患者提供更精准的治疗选择。

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