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貝達藥業(300558.SZ):鹽酸恩沙替尼膠囊啓動歐洲藥品管理局新藥上市審批程序
格隆匯 02-13 17:12

格隆匯2月13日丨貝達藥業(300558.SZ)公佈,今日,貝達藥業股份有限公司控股子公司Xcovery Holdings, Inc.(簡稱“Xcovery”)向歐洲藥品管理局(簡稱“EMA”)提交申報意向書,正式啓動了鹽酸恩沙替尼膠囊(商品名:貝美納®,以下簡稱“恩沙替尼”)“擬用於間變性淋巴瘤激酶(ALK)陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)患者的治療”(即一線適應症)的上市審批程序。

恩沙替尼是一種新型強效、高選擇性的新一代ALK抑制劑,是公司和Xcovery共同開發的自主創新藥。截至公告披露日,已有5款用於ALK陽性的一線治療的藥物在歐洲獲批上市,分別是克唑替尼、塞瑞替尼、阿來替尼、布格替尼、洛拉替尼。

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