复宏汉霖-B(02696.HK)：HLX03汉达远®获批境内上市
格隆汇 12 月 7日丨复宏汉霖-B(02696.HK)宣布，近日，公司自主开发的重组抗肿瘤坏死因子－α("TNF-α")全人单克隆抗体药物HLX03汉达远®(阿达木单抗注射液)的上市注册申请(NDA)获国家药品监督管理局("NMPA")批准，用于治疗：1)类风湿关节炎；2)强直性脊柱炎；3)银屑病。
据悉，HLX03汉达远®(阿达木单抗注射液)是公司按照中国生物类似药指导原则自主开发的单抗生物类似药，主要用于类风湿关节炎、强直性脊柱炎、银屑病的治疗。
2019年1月，HLX03汉达远®(阿达木单抗注射液)的上市注册申请(NDA)获NMPA受理，随后被纳入优先审评程序。2019年7月，HLX03汉达远®(阿达木单抗注射液)用於治疗中重度斑块状银屑病适应症于中国大陆境内完成临床3期试验及临床试验报告，试验结果显示，HLX03汉达远®(阿达木单抗注射液)治疗中重度斑块状银屑病的疗效等效于原研阿达木单抗，在安全性、免疫原性和药代动力学方面与原研阿达木单抗相似。2020年9月，公司位於上海市徐汇区的生物药生产基地("徐汇基地")顺利通过上海市药品监督管理局针对HLX03汉达远®(阿达木单抗注射液)的原液(DS)生产南线及制剂(DP)生产一线的GMP符合性现场检查。
此次HLX03汉达远®(阿达木单抗注射液)获NMPA上市注册申请(NDA)批准主要基于对其与原研阿达木单抗进行的多项头对头比对研究数据的审查，包括药学比对研究、非临床比对研究和临床比对研究相关数据，研究结果证明HLX03汉达远?(阿达木单抗注射液)在安全性、有效性、免疫原性和质量可控等方面与原研阿达木单抗高度相似。
截至公告日，于中国大陆境内上市的阿达木单抗包括艾伯维的修美乐®、浙江海正药业股份有限公司的安健宁、百奥泰生物科技(广州)有限公司的格乐立等。根据IQVIACHAP提供的资料，2019年度及2020年上半年度，阿达木单抗于中国境内的销售金额分别约为人民币0.32亿元、0.45亿元。
公告称，HLX03汉达远®(阿达木单抗注射液)是公司继HLX01汉利康®(利妥昔单抗注射液)、HLX02汉曲优®(注射用曲妥珠单抗)后，第三个于中国境内获批上市的单克隆抗体生物类似药产品。HLX03汉达远®(阿达木单抗注射液)的此次获批上市标志着公司的商业化产品线已拓展至非肿瘤领域，在进一步丰富公司商业化产品线的同时，亦为国内类风湿关节炎、强直性脊柱炎、银屑病患者带来更多的治疗选择。
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