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復星醫藥(600196.SH):子公司撤回色甘酸鈉顆粒的上市許可註冊申請獲批
格隆匯 11-24 17:13

格隆匯11月24日丨復星醫藥(600196.SH)公佈,根據仿製藥審批的相關政策並結合實際情況,公司控股子公司錦州奧鴻藥業有限責任公司(“奧鴻藥業”)向國家藥品監督管理局主動申請撤回色甘酸鈉顆粒(“該新藥”)的上市許可註冊申請,並於近日收到國家藥監局關於同意該撤回申請的通知書。

該新藥為集團(即公司及控股子公司/單位,下同)自主研發的仿製藥,擬主要用於治療食物過敏導致的特應性皮炎。該新藥的註冊上市申請(附豁免臨牀試驗相關説明)於2021年2月獲國家藥監局審評受理。本次撤回申請後,集團將綜合評估(其中主要包括)該新藥補充驗證性臨牀試驗所需的週期、成本以及市場需求等因素,決定該新藥補充臨牀研究、註冊申報等事宜。

根據IQVIA MIDASTM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),2020年度,色甘酸鈉口服制劑的全球銷售額約為4533萬美元。截至2021年10月,集團現階段針對該新藥累計研發投入約為人民幣1118萬元(未經審計)。

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