恆瑞醫藥(600276.SH):罌粟乙碘油注射液獲藥品補充申請批准通知書
格隆匯 1 月 4日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥品補充申請批準通知書》,藥品名稱為罌粟乙碘油注射液。
根據《中華人民共和國藥品管理法》及有關規定,經審查,本品此次申請事項符合藥品註冊的有關要求,批准本品增加適應症“成人肝細胞癌中期患者的動脈化療栓塞治療”的補充申請。
罌粟乙碘油注射液本次申請增加適應症成人肝細胞癌中期患者的動脈化療栓塞治療。本次補充申請於2020年9月獲得國家藥監局受理。
碘化油注射液最早於1954年3月在美國獲批上市,目前已在全球多個國家上市。我國於2001年8月批准法國加柏公司的碘化油注射液進口。公司的罌粟乙碘油注射液與原研產品主要活性成分一致,為碘化罌粟籽油脂肪酸乙酯,適應症為用於碘缺乏病的治療、淋巴造影,已於2016年9月獲批上市,批准文號為“國藥準字H20163348”。經查詢,2019年該產品全球銷售額約4743萬美元。
截至目前,該產品累計已投入研發費用約3122萬元。
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