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恒瑞醫藥(600276.SH)收到國家藥監局核准簽發關於注射用紫杉醇(白蛋白結合型)《藥品補充申請批准通知書》
格隆匯 08-11 15:41

格隆匯8月11日丨恒瑞醫藥(600276.SH)公吿,近日,江蘇恒瑞醫藥股份有限公司(以下簡稱“公司”)收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發關於注射用紫杉醇(白蛋白結合型)的《藥品補充申請批准通知書》。

注射用紫杉醇(白蛋白結合型)是一種抗微管藥物,由美國阿博利斯生命科學公司開發,最早於2005年獲得美國食品藥品監督管理局批准上市,商品名為Abraxane,現已在美國、歐盟、日本等多個國家和地區上市。公司注射用紫杉醇(白蛋白結合型)已於2018年8月獲批上市,用於治療聯合化療失敗的轉移性乳腺癌或輔助化療後6個月內復發的乳腺癌。目前,注射用紫杉醇(白蛋白結合型)國內主要生產廠家有齊魯製藥(海南)有限公司、浙江海正藥業股份有限公司、石藥集團歐意藥業有限公司等。經查詢,注射用紫杉醇(白蛋白結合型)2023年全球銷售額合計約25.97億美元。截至目前,注射用紫杉醇(白蛋白結合型)相關項目累計已投入研發費用約5,291萬元。

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