復星醫藥(02196.HK):治療B淋巴細胞惡性腫瘤新藥"FCN-647膠囊"臨牀試驗申請獲受理
格隆匯10月31日丨復星醫藥(02196.HK)公告,近日,上海復星醫藥(集團)股份有限公司控股子公司重慶復創醫藥研究有限公司收到《受理通知書》(受理號:CXHL1900329國),其研製的FCN-647膠囊用於復發或難治的B淋巴細胞惡性腫瘤治療的臨牀試驗申請獲國家藥品監督管理局(以下簡稱“國家藥監局”)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)自主研發的創新型小分子化學藥物,主要用於復發或難治的B淋巴細胞惡性腫瘤治療。截至公告日,與該新藥同靶點的藥品已於全球上市。
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),與該新藥同靶點的藥品於全球的銷售額約為45.1億美元。
截至2019年9月,集團現階段針對該新藥累計研發投入為人民幣約2368萬元(未經審計)。
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