泰德医药(03880)成功完成HEPCLUDEX®原料药之美国FDA上市许可前检查(PLI)

智通财经07-31

智通财经APP讯，泰德医药(03880)发布公告，公司全资附属公司中肽生化有限公司(“中肽生化”)位于中国杭州的现行生产质量管理规范(“cGMP”)生产设施，已成功通过由美国食品及药物管理局(“FDA”)开展的上市许可前检查(“PLI”)。该项于2026年1月26日至2月3日期间进行的严格现场审查，全面评估了该生产设施就8.5毫克注射用Hepcludex® (bulevirtide-gmod)的...

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