復星醫藥(600196.SH):藥品FCN-338片獲臨牀試驗批准
格隆匯3月31日丨復星醫藥(600196.SH)公佈,公司控股子公司重慶復創醫藥研究有限公司((簡稱“復創醫藥”)於近日收到國家藥品監督管理局關於同意FCN-338片(簡稱“該新藥”)開展聯合阿扎胞苷或化療治療髓系惡性血液疾病臨牀試驗的通知書。復創醫藥擬於條件具備後於中國境內(不包括港澳台地區,下同)開展該適應症的II期臨牀試驗。
該新藥為本集團(即本公司及控股子公司/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於中國境內、美國分別處於I臨牀試驗階段;該新藥用於復發或難治性B細胞淋巴瘤治療於中國境內、美國分別處於I臨牀試驗階段。
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