復宏漢霖-B(02696.HK):用於轉移性乳腺癌、早期乳腺癌治療的注射液臨牀試驗申請獲藥監局批准
格隆匯1月21日丨復宏漢霖-B(02696.HK)公告,公司研製的用於轉移性乳腺癌、早期乳腺癌治療的重組抗HER2結構域II人源化單克隆抗體注射液(HLX11)的臨牀試驗申請已於近日獲國家藥品監督管理局批准。
HLX11是復宏漢霖自主研發的帕妥珠單抗(Pertuzumab,商品名:Perjeta®╱帕捷特@)的生物類似藥,主要適用於以下適應症:1.轉移性乳腺癌,聯合曲妥珠單抗和多西他賽,用於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及2.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。2019年10月31日,用於轉移性乳腺癌、早期乳腺癌治療的HLX11的臨牀試驗申請獲NMPA受理。
截至本公告日,於中國境內上市的重組抗HER2人源化單克隆抗體包括赫賽汀@(注射用曲妥珠單抗)和帕捷特@(帕妥珠單抗注射液)。根據IQVIACHPA資料(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業資訊和戰略諮詢服務提供者),2018年度及2019年前三季度,重組抗HER2人源化單克隆抗體於中國境內的銷售額分別約為人民幣27.3億元、34.4億元。
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