Moderna签订战略合作,拟生产10亿份新冠病毒的mRNA疫苗

2020-05-02 MedSci MedSci原创

上个月,生物技术公司Moderna的mRNA疫苗mRNA-1273率先进入临床测试,该公司也成为第一家在人类身上测试新冠疫苗的公司,后续动向一直备受各界关注。

上个月,生物技术公司Moderna的mRNA疫苗mRNA-1273率先进入临床测试,该公司也成为第一家在人类身上测试新冠疫苗的公司,后续动向一直备受各界关注。 

一周前,Moderna宣布了一项协议,美国生物医学高级研究与开发局(BARDA)承诺提供高达4.83亿美元的资金,用于mRNA-1273的后期加速开发。根据协议条款,BARDA将为mRNA-1273的开发提供资金,以获得FDA的审批许可。该公司股价在周四晚间飙升21%,随着该公司的估值突破150亿美元大关,其市值超过26亿美元。

 

美国国立卫生研究院(NIH)正在进行mRNA-1273的1期研究,并完成了45名年龄在18到55岁之间的成年人的登记。NIH最近修订了第1阶段的方案,增加了6组:3组51-70岁的老年人和3组71岁及以上的老年人,来观察mRNA疫苗在老年人中的效果;这些群组的注册正在进行中。

据美国商业资讯报道,Moderna与Lonza 刚刚宣布了一项为期10年的战略合作协议,以实现大规模生产针对新型冠状病毒(SARS-CoV-2)的Moderna mRNA疫苗(mRNA-1273)以及Moderna其他未来的产品。

根据协议条款,两家公司计划在美国和瑞士的Lonza工厂中完成mRNA-1273的生产制造。预计技术转移将于2020年6月开始,并计划7月份在美国Lonza生产制造第一批mRNA-1273。

之后,双方还计划在Lonza的全球设施中建立更多的生产模块,最终每年可完成相当于10亿份(假设当前预期的剂量为50 µg)mRNA-1273疫苗的生产,供全球使用。在Lonza的制造工厂延续了Moderna在美国正在进行的生产任务,该工作持续进行以准备进一步用于临床开发和mRNA-1273的商业化。

  • 合作目标是每年制造多达10亿剂

  • 预计将于2020年6月开始技术转移

  • 预计首批mRNA-1273将于2020年7月在美国Lonza生产制造

  • 该合作依赖Lonza在技术转移和制造方面的全球专业能力

Moderna与生物医学高级研究与发展局(BARDA)的合同将为该公司在美国Lonza建立生产工厂提供部分资金,该合同是2020年4月16日对外宣布的美国卫生与人类部防备和应对助理部长办公室的一部分服务。BARDA将支持mRNA-1273的后期临床开发计划。

Lonza在扩大创新药物生产方面具有丰富的经验,在整个监管辖区支持了50多个获批的商业化产品,今天他们也将支持Moderna公司的产品线,以满足其供应全球的需求。

Moderna首席执行官Stéphane Bancel说:“我们很高兴与Lonza合作,该公司与我们一样致力于迅速解决这一造成全球性健康危机的流行性疾病。这项长期的战略合作协议会让Moderna大型临床产品组合中的mRNA-1273和其他产品的生产制造能力提高10倍。我们正在以 前所未有 的速度发展,所以Lonza的全球业务和专业知识对我们来说至关重要。我们的共同目标是潜在地制造多达10亿份的mRNA-1273疫苗。”

Lonza 临时董事长兼首席执行官Albert M. Baehny表示:“ Moderna的技术为改变我们保护人们免受疾病侵害的方式提供了重大机遇。当前的大流行说明了将最佳科学与可扩展的弹性供应链相结合的必要性。我们完全致力于利用我们的全球网络和生产经验来支持Moderna mRNA-1273的生产制造以及未来Moderna即将上市的产品。”

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    2020-05-09 般若傻瓜
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    2020-05-02 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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