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奧賽康(002755.SZ):哌柏西利膠囊獲准上市

格隆匯1月6日丨奧賽康(002755.SZ)公佈,公司的全資子公司奧賽康藥業於近日收到藥監局下發的哌柏西利膠囊《藥品註冊證書》,批准該藥品註冊上市。

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。

乳腺癌是女性最常見的惡性腫瘤之一。多年來,內分泌治療一直是晚期乳腺癌的主要治療手段。哌柏西利是美國FDA批准的首個CDK4/6抑制劑,是乳腺癌治療的重大突破,目前已經成為HR陽性、HER2陰性晚期乳腺癌的標準治療方案,得到國際權威指南的推薦。除了作為初始內分泌治療,美國批准聯合氟維司羣用於既往內分泌治療進展的晚期乳腺癌。研究表明,前期接受過多種治療方案的患者仍可在哌柏西利聯合內分泌治療中獲益。此外,相比於化療藥物的不良反應,哌柏西利的不良反應更輕且更易控制。

奧賽康藥業於2018年1月開始研發哌柏西利膠囊,於2021年1月申請藥品註冊,於近日獲得藥監局批准上市。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。

哌柏西利膠囊獲批上市,將進一步豐富臨牀用藥產品供應並增加患者用藥選擇性,使廣大女性患者獲益。Cortellis數據庫顯示,哌柏西利2021年銷售額達到54.37億美元,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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