百济神州(06160.HK)宣布FDA已受理泽布替尼用于治疗先前至少接受过一项治疗的套细胞淋巴瘤患者的新药上市申请并授予优先审评资格
格隆汇8月21日丨百济神州(06160.HK)公布,公司于2019年8月21日宣布美国食品药品监督管理局(FDA)已受理泽布替尼用于治疗先前至少接受过一项治疗的套细胞淋巴瘤(MCL)患者的新药上市申请(NDA)并授予优先审评资格,处方药申报者付费法案(PDUFA)日期为2020年2月27日。FDA于今年早些时候授予泽布替尼针对该适应症的突破性疗法认定。
公告包含根据《1995年私人证券诉讼改革法案》(Private Securities Litigation Reform Act of 1995)以及其他联邦证券法律中定义的前瞻性声明,包括有关泽布替尼用于治疗先前至少接受过一项治疗的套细胞淋巴瘤患者的新药上市申请的药政审评和获批,以及泽布替尼成为治疗套细胞淋巴瘤患者及多项B细胞恶性肿瘤患者的潜在的治疗方案。由于各种重要因素的影响,实际结果可能与前瞻性声明有重大差异。这些因素包括了以下事项的风险:百济神州证明其候选药物功效和安全性的能力;候选药物的临床结果可能不支持进一步开发或上市审批;药政部门的行动可能会影响到临床试验的启动、时程表和进展以及产品上市审批;百济神州的上市产品及药物候选物(如能获批)获得商业成功的能力;百济神州对其技术和药物智慧财产权保护获得和维护的能力;百济神州依赖协力厂商进行药物开发、生产和其他服务的情况;百济神州有限的营运历史和获得进一步的营运资金以完成候选药物开发和商业化的能力;以及百济神州在最近季度报告10-Q表格中“风险因素”章节里更全面讨论的各类风险;以及百济神州向美国证券交易委员会期后呈报中关于潜在风险、不确定性以及其他重要因素的讨论。公告中的所有信息仅及于公告发布之日,除非法律要求,百济神州并无责任更新该些信息。
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