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雅各臣科研製藥(02633.HK)與復星醫藥簽署在香港及澳門分銷2019冠狀病毒病疫苗意向書
格隆匯 08-27 19:47

格隆匯 8 月 27日丨雅各臣科研製藥(02633.HK)公告,公司與上海復星醫藥(集團)股份有限公司("復星醫藥",於中華人民共和國註冊成立的股份有限公司,其股份於香港聯合交易所有限公司(股份代號:2196)及上海證券交易所上市(股票代碼:600196),連同其附屬公司統稱"復星醫藥集團")的全資附屬公司復星實業(香港)有限公司("復星實業")於2020年8月27日訂立一份意向書,內容有關(其中包括)於中華人民共和國香港特別行政區("香港")及澳門特別行政區(("澳門",連同香港,統稱"區域內")供銷潛在1仟萬劑針對2019冠狀病毒病的BioNTechBNT162在研疫苗("2019冠狀病毒病疫苗")("意向書")。

2019冠狀病毒病疫苗基於Biopharmaceutical New TechnologiesSE("BioNTechSE")專有的信使核糖核酸("mRNA")技術平台開發,該公司為於美利堅合眾國("美國")納斯達克上市(股份代號:BNTX)的領先德國生物技術公司。2019冠狀病毒病疫苗是用於預防2019冠狀病毒病感染的mRNA生物製劑,並已進展至臨牀研究三期。BioNTechSE已基於其專有的mRNA平台開發四款在研疫苗,其中兩款(即BNT162b1及BNT162b2)已取得美國食品藥品監督管理局(FoodandDrugAdministration)的快速通道認證。疫苗接種要求參與者在三角肌接受兩劑0.5毫升的BNT162b1或BNT162b2,前後相隔21日注射。

根據BioNTechSE發佈的公開資料,於美國的一期研究中,注射第二劑30微克BNT162b2後,於較年輕成年人(18至55歲)中引起的SARS-CoV-2中和幾何平均滴度是一組38例SARS-CoV-2康復者血清幾何平均滴度的2.8至3.8倍;而該在研疫苗於較年長成年人(65至85歲)中引起的SARS-CoV-2中和幾何平均滴度是同一組康復者血清中和幾何平均滴度的1.1至1.6倍,突顯其對兩個成人組別均有強免疫原性1。在所有人羣中,BNT162b2的使用耐受性良好,少於20%參與者出現輕微至中度發燒2。該等結果使BNT162b2在研疫苗獲選進入於2020年七月開始對多達30,000名參與者進行的關鍵第二╱三階段全球研究,其迄今已招募逾11,000名參與者,包括於SARS-CoV-2大規模傳播的地區3。

復星醫藥集團將致力與BioNTechSE協商,以於區域內供應1仟萬劑2019冠狀病毒病疫苗。根據意向書,公司及╱或其業務合作伙伴將就復星醫藥集團於區域內的2019冠狀病毒病疫苗的銷售、營銷及分銷提供所有相關的支援服務。預期該等服務將主要包括執行銷售及營銷計劃、提供上市後的藥物警戒及處理境內及境外物流,以及法規事務的技術及聯絡支援(統稱"業務合作")。

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