復星醫藥(600196.SH):奧鴻藥業地氯雷他定口服溶液的藥品註冊申請獲受理
格隆匯11月3日丨復星醫藥(600196.SH)公佈,近日,上海復星醫藥(集團)股份有限公司控股子公司錦州奧鴻藥業有限責任公司(簡稱“奧鴻藥業”)研發的地氯雷他定口服溶液(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申請獲國家藥品監督管理局審評受理。
該新藥為集團(即公司及控股子公司/單位,下同)自主研發的化學藥品,擬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。
截至公吿日,於中國境內(不包括港澳台地區,下同)已上市的同類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®、廣東九明製藥有限公司的明妥®等。根據IQVIA CHPA最新數據(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商;IQVIA CHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場,不同的藥品因其各自銷售渠道佈局的不同,實際銷售情況可能與IQVIACHPA數據存在不同程度的差異),2021年度,同類產品於中國境內銷售額約為人民幣2.6億元。
截至2022年9月,集團現階段針對該新藥累計研發投入約為人民幣551萬元(未經審計)。
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