復星醫藥(02196.HK)與BioNTech在中國開始新型肺炎疫苗臨床試驗
復星醫藥(02196.HK)和BioNTech(BNTX.US)宣布,在獲得中國國家藥品監督管理局臨床試驗批准後,截至目前,已有72名受試者接種BNT162b1疫苗。復星醫藥和BioNtech正在中國共同開發針對新冠病毒的mRNA疫苗產品,該試驗是BioNTech全球開發計劃的一部分。
集團指,在中國進行的臨床I期試驗計劃招募144名健康受試者,以評估該候選疫苗的安全性和免疫原性,並確定劑量選擇,受試者將在江蘇省泰州一期臨床基地受試。
是項研究將按照中國的監管審批程序進行,並進一步確認在德國和美國參與試驗的受試者身上觀察到的安全性和免疫原性狀況與中國受試者相當。在德國和美國正在進行的臨床研究將繼續支持在中國的研究。
集團提到,和BioNTech計劃持續探索及推進基於BioNTech專有mRNA技術的其他候選疫苗在中國進行臨床試驗的可能性。在臨床開發階段,BioNTech將通過其在歐洲的GMP認證的mRNA生產設施提供疫苗的臨床供應。如果未來該疫苗獲得銷售許可,復星醫藥將在中國大陸及港澳台地區獨家商業化基於BioNTech mRNA技術平台研發的針對COVID-19的疫苗產品。
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