信达生物(01801.HK)PD-1抑制剂达伯舒联合力比泰和铂类用于治疗肺癌的新适应症申请已获国家药监局受理
格隆汇4月24日丨信达生物(01801.HK)公布，集团和礼来制药共同开发的创新PD-1抑制剂达伯舒（信迪利单抗注射液）联合力比泰（注射用培美曲塞二钠）和铂类用于非鳞状非小细胞肺癌一线治疗的新适应症申请（sNDA）已经正式获中国国家药品监督管理局（NMPA）受理。
基于独立数据监控委员会进行的期中分析，达伯舒联合力比泰和铂类对比安慰剂联合力比泰和铂类，显著延长了无进展生存期，达到预设的优效性标准。截至期中分析数据截止日，中位随访时间为8.9个月，试验组和对照组由独立影像学评审委员会评估的中位PFS分别为8.9个月和5.0个月，HR(95%CI)=0.482(0.362,0.643)，P＜0.00001。安全性特征与既往报道的信迪利单抗研究结果一致，无新的安全性信号。
在中国，肺癌的发病率和死亡率均居所有癌症之首，其中有近半数nsqNSCLC患者无表皮生长因子受体敏感突变或ALK基因重排，致使对靶向药物无效，仍有大量尚未满足的有效治疗方案需求。该项信迪利单抗联合化疗的研究证明其在此类患者人群中显著延缓了疾病进展。公司将积极配合监管机构，尽快将该高质量疗法带给更多有需要的患者。
据悉，达伯舒是集团和礼来在中国共同合作研发的具有国际品质标准的创新药物。NMPA已批准其用于治疗至少经过二线系统化疗的复发╱难治性经典型霍奇金淋巴瘤，并入选2019版中国临床肿瘤学会淋巴瘤诊疗指南。2019年11月，达伯舒成为唯一一个进入国家新版医保目录的PD-1抑制剂。
达伯舒是一种人类免疫球蛋白G4(IgG4)单克隆抗体，能特异性结合T细胞表面的PD-1分子，从而阻断导致肿瘤免疫耐受的PD-1╱程序性死亡受体配体1(Programmed Death-Ligand1,PD-L1)通路，重新激活T细胞杀死肿瘤细胞。目前公司正在开展超过20多项临床研究（其中10多项是注册临床试验），以评估信迪利单抗在各类肿瘤适应症中的有效性和安全性。
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