智通财经APP讯，复宏汉霖(02696)发布公告，近日，公司自主研发的纳武利尤单抗生物类似药HLX18(重组抗PD-1人源化单克隆抗体注射液)(HLX18)用于多种实体瘤治疗的1期临床试验申请(IND)获美国食品药品管理局(FDA)批准。公司拟于条件具备后于美国开展相关1期临床试验。
HLX18是公司自主研发的纳武利尤单抗生物类似药，潜在适应症包括黑色素瘤、非小细胞肺癌、恶性胸膜间皮瘤、肾细胞癌、经典型霍奇金淋巴瘤、头颈部鳞状细胞癌、尿路上皮癌、胃癌、胃食管连接部癌或食管腺癌、食管癌、结直肠癌、肝细胞癌等塬研药已获批的适应症。T细胞中表达的PD-1受体与其配体PD-L1和PD-L2结合，可以抑制T细胞增殖和细胞因子生成。部分肿瘤细胞的PD-1配体上调，通过这个通路信号传导可抑制激活的T细胞对肿瘤的免疫监视。纳武利尤单抗是一种人类免疫球蛋白G4(IgG4)单克隆抗体 (HuMAb)，可与PD-1受体结合，阻断其与PD-L1和PD-L2之间的相互作用，阻断PD1通路介导的免疫抑制反应，包括抗肿瘤免疫反应。
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