復星醫藥(02196.HK):漢霖製藥關於漢曲優變更生產場地、優化生產工藝及擴大製劑規模等補充申請獲批
格隆匯5月17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製藥有限公司(以下簡稱“漢霖製藥”)收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》(通知書編號:2022B02028、2022B02029),漢霖製藥關於漢曲優(注射用曲妥珠單抗)(以下簡稱“該藥品”)變更生產場地、優化生產工藝及擴大製劑規模等補充申請(以下簡稱“本次補充申請”)獲批准。
該藥品為集團(即公司及控股子公司/單位,下同)自主研發的單抗生物類似藥。2020年8月,該藥品獲批於中國境內(不包括港澳台,下同)上市;截至本公吿日,已獲批適應症包括HER2陽性的早期乳腺癌、HER2陽性的轉移性乳腺癌及HER2陽性的轉移性胃腺癌或胃食管交界腺癌等。2021年度,漢曲優(注射用曲妥珠單抗)於中國境內的銷售額約為人民幣8.68億元。
截至公吿日,除漢曲優外,於中國境內上市的曲妥珠單抗包括上海羅氏製藥有限公司的赫賽汀。根據IQVIACHPA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;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年度,曲妥珠單抗於中國境內的銷售額約為人民幣53.72億元。
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