萬泰生物(603392.SH):鼻噴新冠疫苗獲得南非III期臨牀試驗批件
格隆匯11月12日丨萬泰生物(603392.SH)公佈,近日,公司與廈門大學、香港大學合作研發的鼻噴流感病毒載體新冠肺炎疫苗(“鼻噴新冠疫苗”或“該疫苗”)獲得了南非藥監部門簽發的III期臨牀試驗批件,批准鼻噴新冠疫苗在18周歲及以上成人受試者中的保護效力、安全性的國際多中心、隨機、雙盲、安慰劑對照的III期臨牀試驗。
鼻噴新冠疫苗是在雙重減毒的普通季節性流感病毒(CA4-DelNS1)載體內插入新冠病毒保護性抗原的RBD基因序列構建而成的減毒活病毒載體疫苗,經鼻腔噴霧接種,用於新冠肺炎預防。該疫苗是國家部署的我國5條新冠疫苗研發技術路線之一,由公司與香港大學、廈門大學合作研發。該疫苗不同於以產生體液免疫應答為主的肌肉注射疫苗,是模擬新冠病毒天然感染途徑,在呼吸系統特別是肺組織產生很強的T細胞免疫應答,在呼吸道局部尤其是肺部形成預防新冠病毒入侵的第一線免疫屏障。
鼻噴新冠疫苗2020年8月27日獲得國家藥品監督管理局頒發的臨牀試驗批件,已經在國內開展I期、II期和拓展臨牀試驗,I期臨牀試驗已完成計劃內所有訪視,I期和II期均已完成期中分析,研究結果表明該疫苗具有良好的安全性和免疫原性。前期試驗數據顯示該疫苗經鼻噴接種後引發的免疫應答,對新冠病毒原型株和突變株都具有很好的耐受性。I、II期臨牀試驗的安全性評價結果顯示,鼻噴新冠疫苗安全性好,副反應少且程度低。
為加快推進鼻噴新冠疫苗的臨牀III期試驗工作,公司擬在南非、印度尼西亞、菲律賓等11個國家進行臨牀試驗,已與杭州泰格醫藥科技股份有限公司簽署了CRO服務協議,將由其協助公司作為申辦方在上述國家申請並負責具體實施鼻噴新冠疫苗的臨牀III期試驗工作。
截至公吿日,公司在鼻噴新冠疫苗上投入的研發費用約2.01億元人民幣(未經審計)。
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