復星醫藥(600196.SH):FCN-338片用於血液系統惡性腫瘤治療藥品臨牀試驗申請獲受理
格隆匯5月8日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司重慶復創醫藥研究有限公司(“復創醫藥”)收到《受理通知書》,其研製的FCN-338片用於血液系統惡性腫瘤治療獲國家藥品監督管理局(“國家藥監局”)臨牀試驗註冊審評受理。
該新藥為集團(即公司及控股子公司/單位,下同)自主研發的Bcl-2選擇性小分子抑制劑,擬主要用於血液系統惡性腫瘤治療。
截至公告日,與該新藥同靶點的藥品已於全球上市,於中國境內(不包括港澳台地區,下同)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),2019年度,與該新藥同靶點的藥品於全球的銷售額約為7.49億美元。
截至2020年3月,集團現階段針對該新藥累計研發投入為人民幣約2659萬元(未經審計)。
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