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瑞科生物-B(02179.HK):RECOV中國泰州生產基地順利通過歐盟QP審計
格隆匯 04-10 18:56

格隆匯4月10日丨瑞科生物-B(02179.HK)公佈,公司已於2022年4月9日就本集團位於中國泰州的重組蛋白新冠肺炎疫苗ReCOV生產基地獲得由歐盟質量授權人(QP)簽發的符合性聲明。

依據Eudralex Vol 4法規(歐盟質量管理規範)以及國際人用藥品註冊技術協調會(ICH)、美國注射劑協會(PDA)、國際製藥工程協會(ISPE)等指導原則,此次歐盟QP審計主要針對抗原和新型佐劑BFA03的原液及製劑,涵蓋生產管理體系、質量管理體系、廠房設備設施管理體系、驗證和計算機化系統、物料管理系統、產品檢測和放行管理等多方面進行全面系統且深入的檢查。這標誌着集團泰州生產基地和質量管理體系符合歐盟GMP標準,為ReCOV的高品質開發和未來國際商業化打下堅實基礎。

ReCOV為集團綜合運用新型佐劑、蛋白工程平台等技術平台研發的重組新冠肺炎疫苗。根據集團進行的相關研究,ReCOV對奧密克戎、德爾塔等變種病毒具有良好的交叉中和作用和免疫持久性。集團在新西蘭為ReCOV進行的I期試驗的臨牀數據亦顯示,總體安全性良好,相比其他已批准上市的mRNA新冠肺炎疫苗及候選疫苗,ReCOV可潛在性誘導相似或更高水平的中和抗體。

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