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普利製藥(300630.SZ):氟康唑幹混懸劑獲得NMPA上市許可
格隆匯 10-17 16:28

格隆匯10月17日丨普利製藥(300630.SZ)公佈,公司的全資子公司浙江普利藥業有限公司於近日收到國家藥品監督管理局(簡稱“NMPA”)所簽發的氟康唑幹混懸劑的化學藥品3類上市許可。

氟康唑是一種三唑類抗真菌藥物,主要作用機制是高度選擇性地抑制真菌細胞色素P-450甾醇C-14α-脱甲基作用,使真菌內的C-14α-甲基甾醇堆積,從而抑制真菌的繁殖和生長。氟康唑是第一個被世界衞生組織指定的治療全身性真菌感染的首選三唑類藥物,是抗真菌領域的一線藥物。氟康唑由輝瑞公司(PfizerINC)研發團隊研製,並於1990年由美國FDA正式批准該藥品口服和靜脈注射用於治療隱球菌性腦膜炎和各種念球菌病,商品名為DIFLUCAN。後續開發的幹混懸劑於1993年在美國獲得批准上市。使用前以乾粉形式儲存,使用時加入適量水進行復溶後服用。

普利製藥的氟康唑幹混懸劑成功研發後,相繼提交了美國和中國的仿製藥註冊申請,已於2023年9月收到美國食品藥品監督管理局的上市許可通知。近日,公司收到國家藥品監督管理局的上市許可通知,這將對公司拓展中國市場和美國市場帶來積極影響,也為公司後續在幹混懸劑這一劑型領域的研發與國際化上市申請工作積累了非常寶貴的經驗。

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