复星医药(02196.HK)控股子公司获药品临床试验批准
格隆汇7月12日丨复星医药(02196.HK)发布公告,近日,公司控股子公司汉霖生技股份有限公司(以下简称“汉霖生技”)收到台湾“卫生福利部”关于同意HLX10(即重组抗PD-1人源化单克隆抗体注射液;以下简称“该新药”)用于慢性B型肝炎(即慢性乙型肝炎)治疗进行临床试验的函(发文字号:卫授食字第1086012698号)。汉霖生技拟于近期条件具备后于台湾开展针对该适应症的临床II期试验。
公告表示,该新药为集团自主研发的创新型治疗用生物制品,主要用于实体瘤治疗,目前正进一步探索慢性B型肝炎(即慢性乙型肝炎)治疗的可能性。截至本公告日,该新药用于实体瘤治疗于台湾处于临床I期试验中,并已获国家药品监督管理局、美国食品药品监督管理局临床试验批准;该新药联合化疗(顺铂+5-FU)用于一线治疗局部晚期/转移性食管鳞癌于中国大陆处于临床III期试验中。
截至本公告日,于中国大陆上市的重组抗PD-1人源化单克隆抗体注射液包括默沙东制药有限公司的可瑞达、美国百时美施贵宝公司的欧狄沃等。根据IQVIACHPA最新数据(由IQVIA提供,IQVIA是全球领先的医药健康产业专业信息和战略咨询服务提供商),2018年度,重组抗PD-1人源化单克隆抗体注射液于中国大陆销售额约为人民币2668万元。截至2019年6月,集团现阶段针对该新药累计研发投入为人民币约16,128万元(未经审计)。
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