復星醫藥(600196.SH):子公司就FCN-159片用於I型神經纖維瘤的治療啟動II期臨牀研究
格隆匯11月26日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海復星醫藥產業發展有限公司(“復星醫藥產業”)於中國境內(不包括港澳台,下同)就FCN-159片(“該新藥”)用於I型神經纖維瘤的治療啟動II期臨牀研究。
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型神經纖維瘤的治療。截至公吿日,除本次用於I型神經纖維瘤治療於中國境內啟動II期臨牀研究外,該新藥用於具有NRAS突變的晚期黑色素瘤治療於中國境內處於I期臨牀試驗階段、用於治療成人和兒童I型神經纖維瘤(NF1)已於美國獲臨牀試驗批准。
根據IQVIA MIDASTM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),2020年度,MEK1/2選擇性抑制劑於全球市場的銷售額約為11.8億美元。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),2020年度,MEK1/2選擇性抑制劑於中國境內的銷售額約為人民幣61萬元,2021年前三季度,MEK1/2選擇性抑制劑於中國境內的銷售額約為人民幣4,070萬元。
截至2021年10月,集團現階段針對該新藥的累計研發投入為人民幣1.08億元(未經審計)。
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