復星醫藥(02196.HK):單克隆抗體藥物漢利康®獲藥品補充申請批件
格隆匯4月24日丨 復星醫藥(02196.HK)公佈,近日,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《藥品補充申請批件》(批件號:2020B02885),獲批新增500mg/50mL/瓶規格等。
該新藥為集團自主研發的單克隆抗體藥物,主要適用於非霍奇金淋巴瘤、類風濕關節炎的治療。2019年度,集團漢利康®於中國大陸境內的銷售額約為人民幣1.5億元。
截至公告日,於中國境內上市的利妥昔單抗注射液包括上海羅氏製藥有限公司的美羅華®、漢霖製藥的漢利康®。根據IQVIACHPA最新數據,2019年度,利妥昔單抗注射液於中國境內銷售額約為人民幣25.05億元。
截至2020年3月,集團現階段針對該新藥(包括非霍奇金淋巴瘤適應症及類風濕關節炎適應症)已投入研發費用人民幣約59,547萬元(未經審計)。
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