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奧賽康(002755.SZ):子公司泊沙康唑注射液獲得藥品註冊證書
格隆匯 05-06 20:07

格隆匯 5 月 6日丨奧賽康(002755.SZ)公佈,公司的子公司江蘇奧賽康藥有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)核准簽發的泊沙康唑注射液《藥品註冊證書》。

泊沙康唑為新一代三唑類抗真菌藥物,由默沙東(MSD)研發,泊沙康唑(Noxafil)靜脈注射劑20173獲得FDA批准,此前,Noxafil的腸溶片劑型已於201311月獲FDA準。泊沙康唑口服混懸液、腸溶片和注射液三個劑型均已在中國獲批上市。基於奧賽康藥業擁有的難溶性藥物磺丁基倍他環糊精鈉包合製劑技術平台研發的泊沙康唑注射液,於20163月在國內首家獲得臨牀批件,於20188月首家完成了相關臨牀研究申報生產,該申請被CDE入優先審評;奧賽康藥業自主研發泊沙康唑注射液,獲得國家“十三五”“重新藥創制”科技重大專項課題立項。

隨着癌症化療、移植、HIV感染以及糖尿病等高風險患者數量的不斷增多,侵襲性真菌病(IFD)的總髮病率不斷攀升。泊沙康唑可用於預防侵襲性麴黴菌和念珠菌感染。泊沙康唑2020年全球銷售額為3.29億美元,依據PDB數據顯示,2020年泊沙康唑在國內樣本醫院銷售額約為1.40億元

泊沙康唑用於侵襲性真菌感染的預防具有區別於其它藥物的治療優勢前,奧賽康藥業與宣泰醫藥合作的泊沙康唑腸溶片已於20213月獲得NMPA批准,泊沙康唑腸溶片及注射劑均被列入國家首批鼓勵仿製藥品清單,有望成為侵襲性真菌感染序貫防治的經典組合市場前景廣闊

泊沙康唑注射液獲得藥品註冊證書進一步豐富了公司的產品組合有利於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來的經營將產生積極影響。

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