復星醫藥(02196.HK):用於晚期乳腺癌適應症治療新藥啟動II期臨牀研究
格隆匯9月10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(以下簡稱“公司”)控股子公司錦州奧鴻藥業有限責任公司(以下簡稱“奧鴻藥業”)於中國境內(不包括港澳台地區,下同)就FCN-437c(以下簡稱“該新藥”)用於ER+、HER2-的晚期乳腺癌適應症治療啟動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CDK4/6抑制劑,擬主要用於晚期/轉移性實體瘤(包括ER+、HER2-的晚期乳腺癌)治療。該新藥由公司控股子公司重慶復創醫藥研究有限公司進行臨牀前研究,並授予奧鴻藥業在中國境內的獨家開發和市場權利。截至公告日,該新藥於中國境內尚處於I期、II期臨牀研究階段中、於美國尚處於I期臨牀研究階段中。
截至公告日,於中國境內上市的 CDK4/6抑制劑為PfizerInc.的哌柏西利膠囊。根據IQVIACHPA資料(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;IQVIACHPA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IQVIACHPA數據存在不同程度的差異),2019年,哌柏西利膠囊於中國境內的銷售額約為人民幣6,355萬元。
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