四環醫藥(00460.HK):抗腫瘤藥物氟維司羣注射液上市申請獲國家藥監局受理
格隆匯7月27日丨四環醫藥(00460.HK)發佈公吿,國家藥品監督管理局已受理氟維司羣注射液的上市申請。此次上市申請是軒竹生物遞交的首個抗腫瘤藥物上市申請並獲得受理,標誌着軒竹生物的抗腫瘤藥物從研發步入商業化發展的新里程。
氟維司羣注射液臨牀用於雌激素受體陽性(ER+)的局部晚期或轉移性乳腺癌治療。這一重磅藥物將和軒竹生物的另一重磅產品CDK4/6抑制劑吡羅西尼聯合治療晚期乳腺癌,在氟維司羣基礎上聯合CDK4/6抑制劑可以顯着改善患者生存獲益,未來氟維司羣注射液上市後將進一步增強本集團在腫瘤治療領域的實力。
氟維司羣是阿斯利康的抗腫瘤管線的重磅藥物之一,2018年全球銷售峯值超過10億美元。氟維司羣於2010年進入中國,現為2021版國家醫保目錄乙類品種。根據IQVIA 數據顯示,其2021年於樣本公立醫院銷售額超過人民幣5.7億元。隨着乳腺癌治療市場的增長,氟維司羣的銷量有望進一步放量。
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