安科生物(300009.SZ):注射用曲妥珠單抗上市申請獲國家藥監局受理
格隆匯8月4日丨安科生物(300009.SZ)公佈,近日,公司自國家藥品監督管理局網站獲知,公司申報的“注射用曲妥珠單抗”上市許可申請獲得國家藥品監督管理局受理,受理號為:CXSS21*****國。
注射用重組人HER2單克隆抗體(產品名稱:注射用曲妥珠單抗)於2015年獲得藥物臨牀試驗批件,公司按照批件要求並根據《生物類似藥研發與評價技術指導原則》等相關技術指導原則,在中國醫學科學院腫瘤醫院為組長單位的43家研究中心完成了以原研藥注射用曲妥珠單抗(商品名:赫賽汀)(簡稱“赫賽汀”)為對照的III期臨牀試驗,並於2021年6月形成《注射用重組人HER2單克隆抗體Ⅲ期臨牀試驗總結報吿》,結果顯示:試驗藥注射用重組人HER2單克隆抗體與原研藥赫賽汀®在治療HER2陽性轉移性乳腺癌患者中的療效具有類似性、體內代謝特徵、安全性及免疫原性類似。
本品為國內第二個曲妥珠單抗的生物類似藥申報上市品種。根據《生物類似藥相似性評價和適應症外推技術指導原則》,本品在本次申報上市時同時申請適應症外推,擬定適應症為:HER2陽性早期乳腺癌、HER2陽性轉移性乳腺癌、HER2陽性轉移性胃癌。
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