復星醫藥(02196.HK)FCN-159片用於纖維瘤治療獲臨牀試驗審評受理
格隆匯5月7日丨復星醫藥(02196.HK)發佈公告,近日,公司控股子公司上海復星醫藥產業發展有限公司(簡稱“復星醫藥產業”)、重慶復創醫藥研究有限公司(簡稱“復創醫藥”)收到《受理通知書》,其研製的FCN-159片用於I型神經纖維瘤治療獲國家藥品監督管理局臨牀試驗註冊審評受理。
該新藥為集團自主研發的創新型小分子化學藥物,擬主要用於晚期實體瘤、I型神經纖維瘤的治療。截至本公告日,該新藥用於晚期實體瘤治療於中國境內(不包括港澳台地區,下同)處於I期臨牀試驗階段中。
截至本公告日,與該新藥同靶點的藥品已於全球(包括中國境內)上市。根據IQVIAMIDASTM最新數據,2019年度,與該新藥同靶點的藥品於全球銷售額約為9.16億美元。
截至2020年3月,集團現階段針對該新藥已投入研發費用為人民幣約3,889萬元(未經審計)。
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