永泰生物获CDE同意提交EAL附条件批准申请

财中社
28 Feb

2月28日,永泰生物-B(06978)发布公告,告知公司股东及潜在投资者关于核心产品候选药物EAL®的最新业务进展。根据与NMPA(中国国家药品监督管理局)CDE(药品审评中心)的沟通,CDE同意公司可为EAL®提交附条件批准申请。公告指出,虽然公司计划近期提交新药申请,但该申请及所提交的资料将接受CDE的严格审查与评估,若不满足审评条件,CDE可随时终止或拒绝申请。截至公告日期,公司尚未提交关于...

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