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复宏汉霖-B(02696.HK):HLX10用于慢性乙型肝炎治疗的2期临床研究完成首例患者给药
格隆汇 12-31 19:22

格隆汇12月31日丨复宏汉霖-B(02696.HK)宣布,近日,公司重组抗PD-1人源化单克隆抗体注射液(「HLX10」)用于慢性B型肝炎(即慢性乙型肝炎)治疗的2期临床研究完成首例患者给药。

HLX10/HBV-01是一项多中心、开放性的、单臂的2期临床研究,计划入组44例慢性B型肝炎(即慢性乙型肝炎)病毒感染的受试者,通过对其输注HLX10进行治疗。每四周静脉输注一次HLX10(1mg/kg),每位受试者最多输注3次。

该试验主要终点为最后一次接受HLX10输注12周後乙肝表面抗原(HBsAg)水平与基线相比下降0.5log的受试者比例。次要终点包括最后一次接受HLX10输注24周後达到乙肝表面抗原消失的受试者比例,以及HLX10相关的毒性特征。

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。

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