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復星醫藥(02196.HK):用於復發或難治性B細胞淋巴瘤新藥FCN-338片獲批開展臨牀試驗
格隆匯 10-20 19:14

格隆匯10月20日丨復星醫藥(02196.HK)公吿,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“本公司”)控股子公司重慶復創醫藥研究有限公司(以下簡稱“復創醫藥”)收到國家藥品監督管理局關於同意其研製的FCN-338片(規格:10mg、25mg、100mg)(以下簡稱“該新藥”)用於復發或難治性B細胞淋巴瘤開展臨牀試驗的批准。復創醫藥擬於近期條件具備後於中國境內(不包括港澳台地區,下同)開展該新藥的I期臨牀試驗。

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、復發或難治性B細胞淋巴瘤治療。截至本公吿日,該新藥用於血液系統惡性腫瘤治療於中國境內處於I期臨牀試驗階段。

截至公吿日,與該新藥同靶點的藥品於2020年12月在中國境內獲批上市。根據IQVIACHPA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;IQVIACHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場,不同的藥品因其各自銷售渠道佈局的不同,實際銷售情況可能與IQVIACHPA數據存在不同程度的差異),2021年1至6月,與該新藥同靶點的藥品於中國境內的銷售額約為人民幣468萬元。

截至2021年9月,集團現階段針對該新藥(包括用於血液系統惡性腫瘤、復發或難治性B細胞淋巴瘤治療)累計研發投入摺合人民幣約為6,314萬元(未經審計)。

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