智通财经APP讯，永泰生物-B(06978)发布公告，根据本集团近期与中国国家药品监督管理局(NMPA)药品审评中心(CDE)的沟通，CDE同意本集团可为其核心产品候选药物EAL®提交附条件批准申请。
本公司提示，在计划提交新药申请之后，该申请及所提交的资料将由CDE进行严格审查和评估，如结果被认定不满足审评条件，CDE可随时提前终止申请或立即拒绝申请。本公司强调，任何此类申请的提交、时间表、内容及最终批准可能会或可能不会实现，具体取决于多种因素，包括与监管机构的进一步沟通、注册核查的进展以及符合附条件批准的监管要求。
截至本公告日期，本集团尚未提交任何关于EAL®的新药上市申请，计划将于近期提交。提交申请获得CDE受理后，本公司将及时作出公告。
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