信达生物(01801)决定主动撤回帕萨利司片的新药上市许可申请

智通财经网2023-09-28

智通财经APP讯，信达生物(01801)发布公告，此前，该公司向中国国家药品监督管理局递交了帕萨利司片(PI3Kδ抑制剂，研发代号：IBI-376)的新药上市许可申请(NDA)，用于治疗既往接受过至少两种系统性治疗的复发或难治性滤泡性淋巴瘤(FL)的成人患者，并于2023年1月获受理。作为本项申请的最新进展，于申请递交后，由于合作方对该产品海外开发策略的调整，导致该公司后续确证性临床三期研究的投资...

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