复宏汉霖-B(02696.HK)重组抗PD-1人源化单克隆抗体注射液联合化疗治疗胃癌3期临床研究完成首例患者给药
格隆汇12月12日丨复宏汉霖-B(02696.HK)公布,近日,公司重组抗PD-1人源化单克隆抗体注射液(HLX10)联合化疗新辅助╱辅助治疗胃癌的3期临床研究完成首例患者给药。
该研究为一项比较HLX10或安慰剂联合化疗新辅助╱辅助治疗胃癌患者的随机、双盲、多中心3期临床研究,主要目的在于比较HLX10或安慰剂联合化疗新辅助╱辅助治疗胃癌患者的临床疗效,其次旨在比较HLX10或安慰剂联合化疗新辅助╱辅助治疗胃癌患者的安全性和耐受性。
该新药为公司自主研发的创新型治疗用生物制品,主要用于实体瘤治疗,目前正进一步探索用于治疗慢性B型肝炎(即慢性乙型肝炎)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(由IQVIA提供,IQVIA是全球领先的医药健康产业专业信息和战略谘询服务提供商),2018年度,重组抗PD-1人源化单克隆抗体注射液于中国境内销售额约为人民币2,668万元。
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