安科生物(300009.SZ):醋酸阿託西班注射液上市許可申請已獲受理
格隆匯10月23日丨安科生物(300009.SZ)公佈,近日,安徽安科生物工程(集團)股份有限公司收到國家藥品監督管理局行政許可文書《受理通知書》,公司醋酸阿託西班注射液上市許可申請已獲受理,受理號為:CYHS2302813、CYHS2302814。
阿託西班是子宮內及蜕膜、胎膜上受體的催產素競爭性拮抗劑,使用醋酸阿託西班注射液後可劑量相關性地抑制宮縮,並使催產素介導的前列腺素分泌減少,達到保胎目的。阿託西班是具有子宮特異性的宮縮抑制劑,相較於其他宮縮抑制劑,其心血管副作用發生率明顯降低,臨牀使用更為安全。
醋酸阿託西班作為目前歐洲藥品管理局批准用於治療早產的具有子宮特異性的宮縮抑制劑,優點是保胎效果好,對母體及胎兒安全性高,歐洲圍產醫學協會發布的《2017年的早產指南》將阿託西班作為治療早產的一線用藥。
米內網數據顯示,2020-2022年醋酸阿託西班注射液在國內樣本醫院的銷售額分別為3.07億元、4.19億元、4.37億元。
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