復星醫藥(02196.HK):奧鴻藥業就FCN-437c用於治療激素受體陽性(HR+)、人表皮生長因子受體2陰性(HER2-)晚期乳腺癌啟動III期臨牀試驗
格隆匯1月19日丨復星醫藥(02196.HK)發佈公吿,近日,公司控股子公司錦州奧鴻藥業有限責任公司於中國境內(不包括港澳台地區,下同)就FCN-437c用於治療激素受體陽性(HR+)、人表皮生長因子受體2陰性(HER2-)晚期乳腺癌啟動III期臨牀試驗。
該新藥為創新型小分子CDK4/6抑制劑,擬主要用於晚期/轉移性實體瘤(包括HR+、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,並獨家許可奧鴻藥業就該新藥於中國境內進行開發(包括但不限於臨牀試驗、上市註冊等)和商業化。
截至本公吿日,於中國境內上市的CDK4/6抑制劑主要包括Pfizer Inc.的哌柏西利膠囊、Eli Lilly and Company的阿貝西利片(2020年12月獲批上市)等。根據IQVIA CHPA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),2020年度及2021年上半年,CDK4/6抑制劑於中國境內的銷售額分別約為人民幣7,011萬元、3,796萬元。
截至2021年12月,集團(即公司及控股子公司/單位)現階段針對該新藥累計研發投入約為人民幣15,366萬元(未經審計)。
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