奧賽康(002755.SZ):恩格列淨片獲得藥品註冊證書
格隆匯11月19日丨奧賽康(002755.SZ)公佈,公司子公司江蘇奧賽康藥業有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)核准簽發的恩格列淨片《藥品註冊證書》。
恩格列淨(Empagliflozin)是一種高選擇性的SGLT2抑制劑,主要用於改善2型糖尿病患者的血糖控制。最初由美國禮來公司和德國勃林格殷格翰公司合作研發於2014年5月由歐盟委員會首次批准上市,同年8月獲美國FDA批准上市,是全球第3個具有抑制SGLT2作用機制的降糖藥物。中國藥品監督管理局於2017年9月20日批准恩格列淨片進口上市。奧賽康藥業於2017年12月開始研發,2020年4月製劑報產,於近日獲得批准上市,適用於2型糖尿病的治療。
與傳統降糖藥物相比,恩格列淨有着更優良的降糖效果、更穩定的代謝特點以及更好的聯合協同作用。長期服用可以起到保護胰島β細胞功能、控制血壓和體質量的作用,更重要的是可改善患者的心衰預後並降低心血管病死亡率,對患者的病情有着綜合的改善效應。同時,該藥物低血糖反應的發生率更低,其他不良反應相對可控。公司研製的恩格列淨片獲批上市後,可進一步豐富臨牀用藥產品供應,增加患者用藥選擇性,為廣大2型糖尿病患者帶來更多獲益。2020年恩格列淨片國際市場銷售額達11.54億美元,PDB數據庫顯示中國樣本醫院銷售額超過4000萬元,本品種上市後可與公司首仿藥沙格列汀片形成市場協同效應,有較好的市場潛力。
恩格列淨片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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