上海醫藥(02607.HK):甲硝唑片通過仿製藥一致性評價
格隆匯6月25日丨上海醫藥(02607.HK)發佈公吿,近日,公司控股子公司上海信誼萬象藥業股份有限公司收到國家藥品監督管理局頒發的關於甲硝唑片的《藥品補充申請批准通知書》,該藥品通過仿製藥質量和療效一致性評價。
甲硝唑片主要用於治療和預防鑑定為或懷疑是由厭氧菌導致的感染;對多種病原微生物有抑制活性,特別是擬桿菌屬、梭桿菌屬、梭菌屬、真細菌類、消化球菌屬、消化鏈球菌屬、厭氧球菌和陰道加德納氏菌;也對滴蟲、溶組織內阿米巴、賈第鞭毛蟲、結腸小袋纖毛蟲和麥地那龍線蟲等有治療作用。該藥品由GDSEARLE公司研發,最早於1963年在美國上市。2019年1月,信誼萬象就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。
截至本公吿日,公司針對該藥品的一致性評價已投入研發費用約人民幣292萬元。截至本公吿日,中國境內該藥品的主要生產廠家有遠大醫藥(中國)有限公司、四川科倫藥業股份有限公司等。
IQVIA數據庫顯示,2020年該產品醫院採購金額為人民幣2,230萬元。2020年,信誼萬象該藥品的銷售收入為人民幣413萬元。
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