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mRNA疫苗

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上海企业研发mRNA疫苗 获批进入临床试验

(上海30日综合电)中国斯微(上海)生物科技股份有限公司自主研发的新冠病毒mRNA(信使核糖核酸)疫苗,获得中国国家药监局批准,将开展临床试验。

根据上观新闻报道,此次获批开展临床试验的是斯微生物研发的迭代疫苗,这款疫苗在研发设计中包含了德尔塔、奥密克戎等多种新冠病毒变异株均有的D614G突变,对当前新冠病毒流行株具有保护效力,有一定的广谱性。

据了解,斯微生物是中国率先开展mRNA药物研发和mRNA肿瘤精准疫苗人体临床试验的创新型企业之一。公司研发和管理团队汇聚了一批具有丰富经验的科研人员,拥有的核心技术、LPP(脂质多聚复合物)纳米递送系统的全球独家权益,以及自主开发的抗原分析、预测、序列优化平台,并拥有年产数亿剂的大规模生产关键技术和设备的核心专利,关键物料完全实现了国产替代。

目前,斯微生物在上海浦东新区周浦和奉贤区建立了现代化工厂,可实现大规模量化生产,预计两个工厂年产量可达4亿剂。


据报道介绍,mRNA是一种天然分子,能向人体细胞发出指令,然后制造靶蛋白或抗原,从而激发出人体的免疫反应。包裹冠病病毒粒子的脂肪膜表面有刺突糖蛋白,也叫S蛋白,它是瞄准的突破口。mRNA携带蛋白质编码的遗传信息,传递到核糖体机器后能直接翻译成蛋白质,故名“信使核糖核酸”。它如果能翻译成S蛋白,就会产生免疫反应。

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目前在全球多个国家使用的辉瑞、莫德纳均属于


与传统的灭活疫苗、减毒活疫苗相比,的开发更便捷高效。因为灭活疫苗、减毒活疫苗在研发和生产过程中,要对活病毒进行扩增,对扩增设施和安全防控的要求比较高,而开发不需要扩增病毒,关键步骤是在体外合成一种能翻译成特定蛋白质的mRNA。

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mRNA疫苗

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