復星醫藥(600196.SH)：白血病新藥FN-1501獲美國FDA孤兒藥認定
格隆匯11月28日丨復星醫藥(600196.SH)公佈，近日，公司控股子公司上海復星醫藥產業發展有限公司收到美國食品藥品監督管理局(以下簡稱“美國FDA”)關於FN-1501用於急性髓性白血病治療獲得Orphan Drug Designation(即孤兒藥認定，下同)的函。
該新藥為集團經中國藥科大學轉讓、後續自主研發的創新型小分子化學藥物，主要用於白血病治療。該新藥已先後於2017年10月、2017年12月獲美國FDA、國家食品藥品監督管理總局臨牀試驗批准。截至本公告日，該新藥用於治療白血病、實體瘤於美國、澳大利亞、中國境內(不包括港澳台地區，下同)處於I期臨牀試驗中。
截至本公告日，於全球上市的與該新藥同靶點(FLT3)的新藥有諾華的Midostaurin、安斯泰來的Gilteritinib，於中國境內尚無具有自主知識產權的、與該新藥同靶點的藥物上市。
根據IQVIA MIDAS最新數據(由IQVIA提供，IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商)，2018年度，與該新藥同靶點的藥物於全球銷售額約為1.28億美元。截至2019年10月，本集團現階段針對該新藥累計研發投入人民幣約7297萬元(未經審計；包括許可費)。
本次獲得美國FDA的孤兒藥認定，有助於該新藥用於急性髓性白血病治療在美國的後續研發、註冊及商業化等享受一定的政策支持，包括但不限於(1)臨牀試驗費用的税收抵免；(2)免除新藥申請費；(3)享有7年的市場獨佔權、且不受專利的影響。本次認定有利於加強與美國FDA的交流和合作，在一定程度上降低該新藥的研發投入，加快推進臨牀試驗以及上市註冊的進度。
截至本公告日，該新藥尚處於臨牀試驗階段。根據美國相關新藥研發的法規要求，該新藥尚需開展一系列臨牀研究並經藥品審評部門審批通過等，方可上市。
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