港股异动 | 四环医药(00460)涨超6% 旗下轩竹生物自主研发的2个适应症新药上市申请获批

智通财经
16 May

智通财经APP获悉,四环医药(00460)涨超6%,截至发稿,涨6.06%,报0.7港元,成交额3313.19万港元。

消息面上,四环医药发布公告,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CDK4/6(细胞周期依赖性激酶4和6)抑制剂1类新药吡洛西利片(曾用名“吡罗西尼”,XZP-3287,商品名:轩悦宁)2个适应症的新药上市申请(NDA)获得中国国家药品监督管理局颁发的药品注册批件。

具体为:(1)单药用于既往转移性阶段接受过两种及以上内分泌治疗和一种化疗后出现疾病进展的激素受体阳性(HR+)、人表皮生长因子受体2阴性(HER2-)的晚期或转移性乳腺癌成人患者;(2)与氟维司群联合用于既往接受内分泌治疗后出现疾病进展的HR+、HER2-晚期或转移性乳腺癌成人患者。吡洛西利片为国内唯一获批单药用于HR+╱HER2-晚期乳腺癌后线治疗的CDK4/6抑制剂,也是轩竹生物首个获批上市的抗肿瘤创新药。

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