四環醫藥(00460.HK)(口比)洛西利片聯合治療新適應症NDA獲受理
四環醫藥(00460.HK)公布,旗下非全資附屬公司軒竹生物自主研發的1類創新藥(口比)洛西利片(商品名:軒悅寧)新增適應症的新藥上市申請(NDA)獲得中國國家藥品監督管理局(NMPA)受理,具體適應症為與芳香化(酉每)抑制劑聯用作為激素受體陽性(HR+)、人表皮生長因數受體2陰性(HER2-)(HR+/HER2-)晚期乳腺癌患者的初始內分泌治療,以及經他莫昔芬或托瑞米芬輔助治療後進展患者的後續治療。是該產品申報NDA的第3項適應症。
此前產品已獲批聯合氟維司群二線內分泌治療及單藥後線治療兩大適應症,未來該產品將覆蓋HR+/HER2-晚期乳腺癌患者的一線、二線、後線治療的全部人群,將進一步完善乳腺癌全程管理佈局。
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