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復星醫藥(600196.SH):復星醫藥產業用於組織細胞腫瘤治療的FCN-159片獲批臨牀試驗

格隆匯5月12日丨復星醫藥(600196.SH)公佈,近日,上海復星醫藥(集團)股份有限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”)收到國家藥品監督管理局關於同意FCN-159片(以下簡稱“該新藥”)用於組織細胞腫瘤治療開展臨牀試驗的通知書。

復星醫藥產業擬於條件具備後於中國境內(不包括港澳台,下同)開展該適應症的II期臨牀試驗。該新藥為集團(即公司及控股子公司/單位,下同)自主研發的創新型小分子化學藥物,為MEK1/2選擇性抑制劑,擬主要用於晚期實體瘤、I型神經纖維瘤、組織細胞腫瘤等的治療。

截至公吿日,該新藥用於惡性黑色素瘤的治療於中國境內處於I期臨牀試驗階段;該新藥用於I型神經纖維瘤的治療於中國境內處於II期臨牀試驗階段、於美國處於I期臨牀試驗階段。

截至公吿日,於中國境內獲批上市的MEK1/2選擇性抑制劑有諾華集團的邁吉寧®(曲美替尼)。根據IQVIA CHPA數據(由IQVIA提供,IQVIA CHPA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IQVIA CHPA數據存在不同程度的差異),2021年度,MEK1/2選擇性抑制劑於中國境內的銷售額約為人民幣6186萬元。

截至2022年4月,集團現階段針對該新藥累計研發投入約為人民幣1.748億元(未經審計)。

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