复宏汉霖-Ｂ(02696.HK)：重组抗CTLA-4全人单克隆抗体注射液临床申请获药监局受理
格隆汇1月10日丨复宏汉霖-Ｂ(02696.HK)公告，公司研制的用于无法切除或转移性黑色素瘤、晚期肾细胞癌、微卫星高度不稳定性或错配修复缺陷的转移性结直肠癌治疗以及黑色素瘤辅助治疗的重组抗CTLA-4全人单克隆抗体注射液(HLX13)的临床试验申请已于近日获国家药品监督管理局受理。
Ipilimumab是全人、具有κ轻链的抗CTLA-4(细胞毒T淋巴细胞相关抗原4，又称CD152)的IgG1型单克隆抗体。本公司自主研发的HLX13为Ipilimumab的生物类似药，主要用于以下适应症的治疗：1、无法切除或转移性黑色素瘤；2、黑色素瘤的辅助治疗；3、晚期肾细胞癌；4、微卫星高度不稳定或错配修复缺陷的转移性结直肠癌。CTLA-4主要表达在调节性T细胞(Treg)和活化的T细胞上，通过与CD28竞争抗原呈递细胞上的B7配体(B7-1和B7-2)，从而抑制T细胞的增殖和细胞因数(IL-2和IFN-γ)产生。Ipilimumab通过阻断CTLA-4与配体的结合，增强免疫反应进而达到杀伤肿瘤的目的。
根据《生物类似药研发与评价技术指导原则(试行)》，公司对HLX13与原研药Ipilimumab从临床前药理学、药代动力学和毒理学三方面进行头对头比较。比较结果显示，HLX13和Ipilimumab的体外体内药效、药代动力学和毒代动力学特徵、免疫原性和毒性特徵均相似或未见明显差异。
截至本公告日，于全球上市的CTLA-4靶点的单克隆抗体药品有BristolMyersSquibb的Yervoy®(Ipilimumab)，于中国境内(不包括港澳台地区)尚无同靶点的同类药物上市。根据IQVIACHPA资料(由IQVIA提供，IQVIA是全球领先的医药健康产业专业资讯和战略谘询服务提供者)，2018年度，Yervoy®(Ipilimumab)于全球销售额约为13.28亿美元。
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