圣诺生物:子公司被FDA纳入66-40名单 或对业绩产生一定不利影响

智通财经
Sep 22
【圣诺生物:子公司被FDA纳入66-40名单 或对业绩产生一定不利影响】圣诺生物9月22日午间公告,全资子公司圣诺制药于2026年8月接受美国食品药品管理局检查组的现场检查。FDA检查组于8月27日依据美国相关法规向公司签发了FormFDA 483观察表载明8项观察项。公司已向FDA提交了对上述483的初始回复及相关整改措施。截至目前,经查询FDA官方网站,圣诺制药已于2026年9月19日被列入第66-40号进口禁令名单;但尚未收到美国FDA作出的官方行动指示结论,亦尚未收到FDA警告信。公司2026年上半年对美国实现销售收入1.67亿元,占公司同期营业收入比重为32.83%。因此,该事项未来可能会对公司经营业绩产生一定不利影响。公司承诺圣诺制药解除FDA相关警示前,全面停止所有多肽原料药对美国市场的销售与发运。

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