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復宏漢霖-B(02696.HK):乳腺癌治療新藥HLX11臨牀試驗申請獲受理
格隆匯 10-31 19:20

格隆匯10月31日丨復宏漢霖-B(02696.HK)公佈,公司研製的用於轉移性乳腺癌、早期乳腺癌治療的HLX11的臨牀試驗申請已於近日獲國家藥品監督管理局("NMPA")受理。

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。帕妥珠單抗是HER2陽性乳腺癌第二代靶向治療藥物,作用於HER2細胞外結構域II,抑制二聚體的形成,阻斷下游信號通路,從而抑制腫瘤細胞的增殖,同時可通過抗體依賴性細胞介導的細胞毒性(ADCC)作用達到增強免疫細胞對腫瘤細胞的殺傷能力。

HLX11適用於以下適應症:1.轉移性乳腺癌,適用於聯合曲妥珠單抗和多西他賽,用於治療未接受過抗HER2治療或轉移性癌症化療的HER2陽性轉移性乳腺癌患者及2.早期乳腺癌,與曲妥珠單抗和化療聯合,作為早期乳腺癌完整治療方案的壹部分,用於HER2陽性、局部晚期、炎性或早期乳腺癌(直徑>2cm或淋巴結陽性)患者的新輔助治療;用於高復發風險的HER2陽性早期乳腺癌患者的輔助治療。目前已有大量的臨牀研究數據表明,使用帕妥珠單抗+曲妥珠單抗+化療治療的患者與僅使用曲妥珠單抗+化療治療的患者相比無進展生存期延長、生存率提高及緩解率提升,給患者帶來了顯著的生存獲益。

截至公告日,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),2018年度,重組抗HER2人源化單克隆抗體於中國境內的銷售額約為人民幣27.3億元。

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