复宏汉霖HLX04-O临床试验达主要研究终点

财中社
03 Apr

  4月2日,复宏汉霖(02696)发布公告,近日其重组抗VEGF人源化单克隆抗体注射液HLX04-O在一项针对湿性年龄相关性黄斑变性(wAMD)的3期临床研究中达到了主要研究终点。

  这项研究是多中心、随机、双盲的非劣效试验,旨在比较HLX04-O与雷珠单抗的有效性和安全性。研究结果显示,HLX04-O组第48周最佳矫正视力(BCVA)较基线改善的平均字母数变化结果非劣于雷珠单抗组,且两者的安全性特征相似,表现良好。

  HLX04-O是基于本公司自主研发的汉贝泰®(贝伐珠单抗注射液)进行优化的眼科制剂,旨在治疗湿性年龄相关性黄斑变性(wAMD)。截至公告日,HLX04-O的3期临床研究正在中国及多个国际市场有序开展,2024年中国境内针对wAMD适应症的药物销售额预计约为41.8亿元。

(文章来源:财中社)

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