復星醫藥(02196.HK)公佈控股子公司藥品臨牀試驗進展
格隆匯4月28日丨復星醫藥(02196.HK)公吿,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司(以下合稱“復宏漢霖”)自主研發的重組抗HER2結構域II人源化單克隆抗體注射液(即HLX11;以下簡稱“該新藥”)就用於HER2陽性且HR陰性的早期或局部晚期乳腺癌新輔助治療於中國境內(不包括港澳台地區,下同)啟動III期臨牀試驗。
該新藥為集團(即公司及控股子公司/單位,下同)自主研發的帕妥珠單抗生物類似藥。其原研藥用於以下適應症:(1)早期乳腺癌:與曲妥珠單抗和化療聯合,作為早期乳腺癌整體治療方案的一部分,用於HER2陽性、局部晚期、炎性或早期乳腺癌患者(直徑>2cm或淋巴結陽性)的新輔助治療,用於具有高復發風險的HER2陽性早期乳腺癌患者的輔助治療;及(2)轉移性乳腺癌:與曲妥珠單抗和多西他賽聯合治療既往未接受過抗HER2治療或化療的HER2陽性、轉移性或不可切除的局部複發性乳腺癌患者。
截至公吿日,於中國境內上市的帕妥珠單抗注射液為上海羅氏製藥有限公司的帕捷特。根據IQVIACHPA提供的資料(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),2021年,帕妥珠單抗注射液於中國境內的銷售額約為人民幣26.13億元。
截至2022年3月,集團現階段針對該新藥累計研發投入為人民幣約12,188萬元(未經審計)。
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