復星醫藥(02196.HK)：控股子公司藥品納入突破性治療藥物程序
格隆匯7月25日丨復星醫藥(02196.HK)公佈，根據國家藥品監督管理局(以下簡稱"國家藥監局")藥品審評中心發佈的公示信息，公司控股子公司上海復星醫藥產業發展有限公司的 FCN-159 片(以下簡稱"該新藥")用於治療無法手術或術後殘留/復發的 NF1(即 I 型神經纖維瘤)相關的叢狀神經纖維瘤成人患者已被納入突破性治療藥物程序。
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、動靜脈畸形等的治療。
截至公吿日，該新藥用於成人 I 型神經纖維瘤的治療於中國境內(不包括港澳台地區，下同)處於 III 期臨牀試驗階段，該新藥用於成人和兒童 I 型神經纖維瘤治療的中國、美國及歐洲的國際多中心 II 期臨牀試驗仍在進行中；該新藥用於組織細胞腫瘤、低級別腦膠質瘤以及動靜脈畸形的治療分別於中國境內處於 II 期臨牀試驗階段，其中，該新藥用於組織細胞腫瘤治療亦被納入突破性藥物治療程序；該新藥用於治療兒童朗格漢斯細胞組織細胞增生症/朗格罕細胞組織細胞增生症的II期臨牀試驗申請已獲國家藥監局批准。
截至公吿日，於中國境內已獲批上市的 MEK1/2 選擇性抑制劑有 NovartisEuropharm Limited 的邁吉寧®(曲美替尼片)。根據 IQVIA CHPA 最新數據(由 IQVIA提供，IQVIA 是醫藥健康產業專業信息和戰略諮詢服務提供商；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)，2022 年，MEK1/2 選擇性抑制劑於中國境內的銷售額約為人民幣 10,236 萬元。
截至 2023 年 6 月，集團現階段針對該新藥累計研發投入約為人民幣 35,769萬元(未經審計)。
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