奧賽康(002755.SZ):子公司哌柏西利膠囊新規格獲准上市
格隆匯12月15日丨奧賽康(002755.SZ)公佈,公司的全資子公司江蘇奧賽康藥業有限公司(簡稱“奧賽康藥業”)於近日收到國家藥品監督管理局下發的哌柏西利膠囊《藥品補充申請批准通知書》,同意公司哌柏西利膠囊在已有125mg規格基礎上增加75mg規格、100mg規格,並核發新的藥品批准文號。
哌柏西利(Palbociclib)是一種細胞週期蛋白依賴性激酶(CDK)4/6抑制劑,適用於雌激素受體(HR)陽性和人表皮生長因子受體(HER2)陰性的絕經後晚期乳腺癌的治療。最初由Pfizer(輝瑞)研發,於2015年3月獲美國FDA批准上市,2016年11月獲歐盟委員會批准上市,2017年9月獲PMDA批准在日本上市。國家藥品監督管理局於2018年批准哌柏西利膠囊進口上市。
該藥品適用於HR陽性、HER2陰性的局部晚期或轉移性乳腺癌,應與芳香化酶抑制劑聯合使用作為絕經後女性患者的初始內分泌治療。Cortellis數據庫顯示,哌柏西利2022年銷售額達到51.2億美金,已成為國際上乳腺癌的重磅治療藥物,具有較好的市場潛力。
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