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奧賽康(002755.SZ):注射用達託黴素(0.35g)獲批上市
格隆匯 06-21 17:44

格隆匯6月21日丨奧賽康(002755.SZ)宣佈,公司的子公司江蘇奧賽康藥業有限公司於近日收到國家藥監局核准簽發的關於注射用達託黴素(0.35g)的《藥品註冊證書》。

達託黴素(Daptomycin)是一種環脂肽類抗生素,由Lilly(禮來)公司最初研究,Cubist製藥公司開發上市。2003年FDA批准注射用達託黴素用於治療由G+敏感菌株引起的併發性皮膚及皮膚結構感染,如膿腫、手術切口感染和皮膚潰瘍。我國於2009年批准該品種進口,用於治療金黃色葡萄球菌(包括甲氧西林敏感和甲氧西林耐藥)導致的伴發右側感染性心內膜炎的血流感染(菌血症),2013年批准了新增血流感染和皮膚感染及軟組織感染的適應症。公司研製開發了注射用達託黴素,規格為0.35g,按原化學藥品第6類申報,獲得NMPA批准上市。

達託黴素的長脂肪鏈會與細胞膜間存在交互作用,當其與鈣離子結合時會滲透進入細胞膜的內層,並透過達託黴素的聚集效應在細胞膜表面產生一個通道,使鉀離子流失,這就導致了細胞膜的去極化而使細胞瓦解,並加速了細胞的死亡。由於其獨特的作用機理,快速強效的抗菌作用使得達託黴素成為治療耐甲氧西林金黃色葡萄球菌(MRSA)感染的強大武器,受到廣大抗感染臨牀專家的認可,被納入中國MRSA共識。達託黴素2020年國際市場銷售額為1.52億美元,PDB數據庫顯示2020年中國樣本醫院銷售額達4543萬元。

司研發的注射用達託黴素(0.35g)新規格上市,為臨牀醫生提供了更多的用藥選擇。注射用達託黴素獲得藥品註冊證書進一步豐富了公司的產品組合,有利於提升該藥品的市場競爭力,擴大市場份額。同時對市場的拓展以及公司及子公司未來的經營將產生積極影響。

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