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三葉草生物-B(02197.HK)宣佈新冠疫苗加強針在中國上市
格隆匯 02-14 12:03

格隆匯2月14日丨三葉草生物-B(02197.HK)宣佈其重組蛋白新冠疫苗上市,已於浙江長興交付並進行了首針接種。作為國家第二劑次(第四針)加強免疫接種實施方案被推薦接種的疫苗,可針對老年人羣、免疫力低下人羣和有合併症人羣。

三葉草生物的重組蛋白新冠疫苗2022年12月被授權在中國緊急使用。隨後中國國家衞生健康委員會正式公佈《新冠病毒疫苗第二劑次加強免疫接種實施方案》,建議優先使用針對奧密克戎具有廣泛中和作用的疫苗,包括三葉草生物的重組蛋白新冠疫苗。

遍佈全球五個國家、入組超過3萬名受試者的SPECTRA II/III期臨牀數據顯示,三葉草生物的重組蛋白新冠疫苗在臨牀試驗中對試驗期間流行的所有新冠病毒毒株引起的重度和需住院治療的新冠感染的保護效力為100%。此外,上述II/III期臨牀試驗中的一項研究表明,與受感染的家庭成員沒有接種疫苗的家庭相比,當受感染的家庭成員接種了三葉草生物的新冠疫苗時,家庭成員間感染新冠病毒的可能性降低了84%。最,在一項獨立的III期臨牀研究中,三葉草生物的新冠疫苗在作為兩劑滅活疫苗的第三劑異源加強針時,針對多種奧密克戎變異株亞型,包括奧密克戎BA.1、BA.2和BA.5,均可誘導顯著的優第三劑滅活疫苗的中和反應。加強疫苗針對最近流行的奧密克戎變異株亞型,包括奧密克戎BF.7、BQ.1.1和BA.2.75的中和反應的分析結果與之前的數據一致。

除浙江省外,公司已在多個具有戰略優勢的省市開展上市準備工作,預計將今年第一季度在多個省市陸續上市。根據生產能力和市場動態,公司將在今年持續擴展其在國內的業務。同時,基通過雙邊供應協議可產生的潛在顯著近期營收和影響的考量,公司將優先考慮在選定的國家(主要分佈亞太地區和拉丁美洲)直接提交註冊申請或緊急使用授權申請。

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