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復星醫藥(02196.HK)子公司獲藥品補充申請批准通知書
格隆匯 07-14 16:35

格隆匯 7 月 14日丨復星醫藥(02196.HK)公告,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司上海復宏漢霖生物製藥有限公司(以下簡稱“漢霖製藥”)收到國家藥品監督管理局頒發的關於利妥昔單抗注射液(即重組人鼠嵌合抗CD20單克隆抗體注射液,商品名稱:漢利康;以下簡稱“該新藥”)的《藥品補充申請批准通知書》(通知書編號:2020B04026、2020B04027),該新藥獲批(其中包括)用於兩項新增適應症:(1)初治濾泡性淋巴瘤患者經利妥昔單抗聯合化療後達完全或部分緩解後的單藥維持治療、(2)與氟達拉濱和環磷酰胺聯合治療先前未經治療或複發性/難治性慢性淋巴細胞白血病患者。

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