復星醫藥(02196.HK)利妥昔單抗注射液新增兩項適應症獲註冊補充申請受理
格隆匯5月19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收到《受理通知書》,其利妥昔單抗注射液(即重組人鼠嵌合抗CD20單克隆抗體注射液,商品名稱:漢利康)新增兩項適應症(即用於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,下同)獲國家藥品監督管理局藥品註冊審評受理。
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、類風濕關節炎等治療。2019年度,集團漢利康於中國境內(不包括港澳台地區,下同)的銷售額約為人民幣1.5億元。
截至本公告日,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4月,集團現階段針對該新藥已投入研發費用人民幣約60,873萬元(未經審計)。
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