智通财经APP讯，复宏汉霖(02696)发布公告，近日，注射用HLX43(靶向PD-L1抗体偶联药物)(HLX43)联合HLX07(重组抗EGFR人源化单克隆抗体注射液)(HLX07)用于晚期/转移性实体瘤治疗的1b/2期临床试验申请获国家药品监督管理局(NMPA)批准。
HLX43是由公司利用许可引进的新型DNA拓扑异构酶I抑制剂小分子毒素-肽链连接子与公司自主研发的靶向PD-L1的抗体进行偶联开发的靶向PD-L1的抗体偶联药物(ADC)，拟用于晚期/转移性实体瘤的治疗。
HLX07为公司自主研发的针对EGFR靶点的创新型生物药，计划用于晚期实体瘤治疗。2023年2月，HLX07联合化疗用于晚期实体瘤治疗的1b/2期临床研究结果显示其安全性及耐受性良好。目前，多项关于HLX07的2期临床研究正于中国境内开展，主要包括HLX07单药用于治疗晚期皮肤鳞状细胞癌(CSCC)等实体瘤的2期临床试验及汉斯状®联合HLX07用于治疗晚期或转移性鳞状非小细胞肺癌(sqNSCLC)等实体瘤的2期临床试验。
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