复星医药(02196.HK)重组抗PD-1人源化单克隆抗体注射液联合化疗启动III期临床研究
格隆汇9月12日丨复星医药(02196.HK)公布,近日,公司控股子公司上海复宏汉霖生物技术股份有限公司于中国境内就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”)联合化疗(卡铂-依托泊苷)用于治疗未接受过治疗的广泛期小细胞肺癌启动III期临床研究。
该新药为本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,目前也正进一步探索慢性乙型肝炎治疗的可能性。
截至本公告日,于中国境内上市的重组抗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,2018年度,重组抗PD-1人源化单克隆抗体注射液于中国境内销售额约为人民币2,668万元。
截至2019年8月,本集团现阶段针对该新药的累计研发投入为人民币约1.96亿元(未经审计)。
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