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復星醫藥(02196.HK)控股子公司獲藥品註冊批準

格隆匯5月29日丨復星醫藥(02196.HK)發佈公告,近日,公司控股子公司錦州奧鴻藥業有限責任公司就枸櫞酸伏維西利膠囊(商品名:復妥寧,項目代號:FCN-437c;以下簡稱“該新藥”)的上市註冊申請獲國家藥品監督管理局(以下簡稱“國家藥監局”)批準,本次獲批適應症爲聯合氟維司羣用於既往接受內分泌治療後出現疾病進展的激素受體(HR)陽性、人表皮生長因子2(HER2)陰性的復發或轉移性成年乳腺癌患者。

該新藥爲集團擁有自主知識產權的創新型小分子CDK4/6抑制劑,是一種口服、強效、高選擇性、全新結構的創新小分子藥物,於2018年被列入國家“重大新藥創制”科技重大專項。

除本次獲批的適應症外,該新藥另一適應症(用於激素受體(HR)陽性、人表皮生長因子受體2(HER2)陰性的局部晚期或轉移性乳腺癌,應與芳香化酶抑制劑聯合使用作爲絕經前、絕經後、圍絕經期女性乳腺癌患者的初始內分泌治療)的藥品註冊申請已於2025年1月獲國家藥監局受理。

截至2025年4月,集團現階段針對該新藥的累計研發投入約爲人民幣6.01億元(未經審計)。根據IQVIA MIDAS最新數據1,2024年,CDK4/6抑制劑於全球範圍內的銷售額約爲147.77億美元。

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