金吾财讯 | 查尔斯河实验室（CRL）宣布，与中国台湾高端疫苗生物制药股份有限公司（简称MVC）达成战略合作。双方将利用二代测序（NGS）技术，共同推进高端疫苗旗下“下一代多价肠道病毒疫苗”的毒株种子库鉴定、验证及生产质量控制（CMC）相关流程。据介绍，本次合作将结合查尔斯河实验室在病毒学、非临床研究及符合国际监管标准（如FDA、EMA、ICHQ5A/Q5B及CGMP）的NGS测试平台优势，以及高端疫苗在肠道病毒领域的研发经验。双方旨在加速生成支持新药临床试验申请（IND）所需的数据，推动该疫苗迈入全球临床阶段，并符合国际监管体系要求。据悉，高端疫苗此前研发的单价肠道病毒71型（EV71）疫苗已在中国台湾及越南获批上市。
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