艾美疫苗人二倍体狂犬疫苗获临床试验批准
3月9日，艾美疫苗（06660）发布公告，宣布其研发的人二倍体狂犬疫苗已获得国家药品监督管理局的《药物临床试验批准通知书》。该疫苗是一款迭代升级的高效价产品，具有明显的超高效价特性，动物试验显示其免疫后可产生高保护水平的抗体，效价显著高于市场上已上市的人二倍体狂犬疫苗。
此次疫苗的研发突破了传统工艺中的技术瓶颈，优化了纯化工艺，提高了产品质量和安全性。此外，该疫苗在接种方式上灵活多样，既可采用“五针法”，也可采用“简易四针法”及“2-1-1四针法”。
目前公司已建立符合国际标准的生产车间，并完成了商业化规模的三期临床试验样品生产，具备规模化生产能力。此次临床试验的批准将进一步巩固公司在全球狂犬疫苗领域的领先地位。
（文章来源：财中社）
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