信达生物新药上市申请获得受理
2月24日，信达生物（01801）发布公告，宣布伊匹木单抗注射液联合信迪利单抗用于结肠癌的新辅助治疗的新药上市申请已获得中国国家药品监督管理局受理，并纳入优先审评程序。该药物的研发代号为IBI310，是首个递交NDA的中国研发CTLA-4单抗。此次申请的基础是基于在中国开展的随机、对照、多中心、III期注册研究（NeoShot，NCT05890742）的结果。
根据研究结果，伊匹木单抗联合信迪利单抗的新辅助治疗组的病理完全缓解率（pCR）为80.0%，显著高于信迪利单抗单药组的47.7%（p=0.0007）。两组的受试者肿瘤完全切除率均为100%，且中位随访时间为5.65个月，未发生疾病复发事件。此外，联合治疗组的术后病理淋巴结阳性率为3.9%，而单药组为15.9%。研究表明，伊匹木单抗联合信迪利单抗的安全性良好，没有增加额外的安全性风险。
此次新适应症的申报上市，预计将为可切除的MSI-H/dMMR结肠癌患者带来新的治疗选择，信达生物也将继续致力于巩固在肿瘤治疗领域的领导地位。
（文章来源：财中社）
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