翰森製藥(03692.HK)利奈唑胺片獲藥品註冊批件
格隆匯12月20日丨翰森製藥(03692.HK)公佈,由公司附屬公司江蘇豪森藥業集團有限公司開發的抗感染新藥利奈唑胺片(商品名稱恆捷)已獲中國國家藥品監督管理局頒發藥品註冊批件,獲批上市。
恆捷按照化藥新4類申報,視同通過一致性評價,用於治療甲氧西林敏感或耐藥的陽性菌引起的感染。利奈唑胺被列入《世界衞生組織基本藥物標準清單(2019年第21版)》中,並且被世界衞生組織推薦為長程治療多耐藥結核病患者的藥物。恆捷獲批上市,將給耐藥結核病患者帶來新的用藥選擇,以及更加方便該等患者的長期用藥。
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