恆瑞醫藥(600276.SH):取得鹽酸伊立替康注射液的藥品註冊證書
格隆匯5月25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核准簽發的關於鹽酸伊立替康注射液的《藥品注冊證書》。
本品適用於晚期大腸癌患者的治療:(1)與5-氟尿嘧啶和亞葉酸聯合治療既往未接受化療的晚期大腸癌患者;(2)作為單一用藥,治療經含5-氟尿嘧啶化療方案治療失敗的患者。
鹽酸伊立替康注射液由日本養樂多、福島第一製藥、羅納普朗克和法瑪西亞&厄普約翰聯合開發,於1996年6月在美國首次獲批,商品名為Camptosar。截至目前,本品已在包括中國在內的多個國家廣泛上市銷售。除公司外,國內另有海南錦瑞、齊魯製藥(海南)、上海創諾、哈藥集團及四川匯宇獲批生產。
經查詢,伊立替康注射劑2019年全球銷售額約7.24億美元,暫未查到2020年度銷售數據。截至目前,鹽酸伊立替康注射液(2ml:40mg)報產階段已投入研發費用約為603萬元人民幣。
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