海正藥業(600267.SH):海正生物的“注射用曲妥珠單抗”申請境內生產藥品註冊上市許可已獲受理
格隆匯1月13日丨海正藥業(600267.SH)公佈,2022年1月13日,博鋭生物全資子公司海正生物製藥有限公司(“海正生物”)從國家藥品監督管理局藥品業務應用系統獲悉其品種“注射用曲妥珠單抗”申請境內生產藥品註冊上市許可已獲受理。
該項目後續將接受國家藥品審評中心的技術審評、臨牀試驗現場核查、藥品註冊生產現場檢查等事宜,海正生物將積極做好有關準備工作。
根據海正藥業、海正藥業(杭州)有限公司與太盟簽訂的《浙江海正博鋭生物製藥有限公司股權轉讓合同》及其補充約定,如博鋭生物、海正生物或各方同意的博鋭生物其他特定全資子公司依法按期獲發其名下的曲妥珠單抗藥品上市批件,完成股權轉讓合同中里程碑補償款和特殊轉移補償款中的曲妥珠單抗特定事件,則不會觸發曲妥珠單抗特定事件對太盟的現金補償義務。
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