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復星醫藥(02196.HK):FCN-159片用於I型神經纖維瘤的治療獲批開展臨牀試驗
格隆匯 06-28 21:21

格隆匯 6 月 28日丨復星醫藥(02196.HK)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(“復星醫藥產業”)及重慶復創醫藥研究有限公司(“重慶復創”)收到國家藥品監督管理局關於同意其研製的FCN-159片用於I神經纖維瘤治療開展臨牀試驗的通知醫藥產業近期條件具備中國境內(不包括港澳台地區,下同)開展該針對上述適應症I臨牀試驗

該新藥為集團自主研發的創新型小分子化學藥物,MEK1/2選擇性抑制劑主要用於晚期實體瘤I神經纖維瘤治療。截至公告日,該新藥用於晚期實體瘤的治療中國境內處於I臨牀試驗階段

截至公告日,於全球上市的MEK1/2選擇性抑制劑Novartis Pharma Schweiz AGTrametinibRoche Pharma (Schweiz) AGCobimetinib其中Trametinib2019年在中國境內上市。根據IQVIAMIDASTM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,MEK1/2選擇性抑制劑於全球銷售額約為9.16億美元。

截至20205月,集團現階段針對該新藥已投入研發費用為人民幣約4042萬元(未經審計)。

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