復星醫藥(02196.HK)控股子公司獲藥品註冊批准
格隆匯5月27日丨復星醫藥(02196.HK)發佈公吿,公司控股子公司錦州奧鴻藥業有限責任公司、遼寧兒童製藥有限公司於近日收到國家藥品監督管理局關於地氯雷他定口服溶液(以下簡稱“該新藥”)用於緩解慢性特發性蕁麻疹及過敏性鼻炎的全身及局部症狀的藥品註冊批准。
該新藥為集團自主研發的化學藥品,主要用於緩解慢性特發性蕁麻疹及過敏性鼻炎的全身及局部症狀。
截至2024年4月,集團現階段針對該新藥累計研發投入約為人民幣817萬元(未經審計)。
截至本公吿日,除該新藥外,於中國境內(不包括港澳台地區,下同)已獲批上市的其他地氯雷他定產品主要包括海南普利製藥股份有限公司的芙必叮、萬特製藥(海南)有限公司的百新哈、四川成都同道堂製藥有限責任公司的地氯雷他定糖漿等。根據IQVIACHPA最新數據,2023年,地氯雷他定產品於中國境內的銷售額約為人民幣3.15億元。
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