智通财经APP讯，永泰生物-B(06978)发布公告，先前公司已就EAL®用于预防肝癌术后复发向CDE提交附条件上市申请。现公司接获CDE日期为2026年4月27日的《关于EAL®附条件上市申请不予批准的告知书》，告知书中指出：“已有临床实验资料表明，EAL®在免疫特性人群中显示出了获益趋势，需在该人群中开展确证性临床试验，因未提交免疫特性人群确证性临床试验结果，无法对本品的获益风险进行综合评价，不能支持本品上市许可申请。”
依据相关法规规定，本次不予批准告知书仅针对附条件批准上市申请，公司将积极开展后续确证性临床研究的准备工作，并在完成相应研究后按常规批准程式重新申报集团核心候选产品EAL®的上市申请。
此外，公司已向联交所申请公司股份自2026年4月29日(星期三)上午9时正起恢复买卖。
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