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信达生物-B(01801.HK):达伯舒®已获国家药监局批准上市销售用于治疗复发或难治性经典霍奇金淋巴瘤
格隆汇 07-25 08:29

格隆汇7月25日丨信达生物-B(01801.HK)公布,达伯舒®(化学通用名:信迪利单抗注射液,全人源程序性细胞死亡蛋白1(PD-1)单克隆抗体)和IBI-305(贝伐珠单抗的生物类似药,又名重组人源化抗血管内皮生长因子(抗VEGF)单克隆抗体)联合化疗(培美曲塞±顺铂)治疗用于表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗失败的表皮生长因子受体突变(EGFRm)非鳞非小细胞肺癌(nsqNSCLC)患者的III期临床研究完成首例患者给药。

公告显示,达伯舒®是集团与礼来公司在中国共同开发的一种创新药。集团目前正在美利坚合众国对信迪利单抗注射液进行临床研究。达伯舒®是一种免疫球蛋白G4单克隆抗体,能结合T细胞表面的PD-1分子,从而阻断PD-1/PD1配体1通路并重新激活T细胞以杀死癌细胞。

达伯舒®是中国唯一同时具备当地生物制药公司及全球制药公司商标的PD-1抗体。达伯舒®已获中国国家药品监督管理局(NMPA)批准上市销售,用于治疗复发或难治性经典霍奇金淋巴瘤(r/rCHL),并入选2019版中国临床肿瘤学会(CSCO)淋巴瘤诊疗指南。目前有超过20项正在进行的评估信迪利单抗注射液对其他实体瘤的有效性的临床研究,其中8项是注册临床试验。

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