复宏汉霖(02696)：注射用HLX43(靶向PD-L1抗体偶联药物)联合贝伐珠单抗联合或不联合化疗用于晚期/转移性实体瘤治疗的临床试验申请获国家药品监督管理局批准

智通财经07-31

智通财经APP讯，复宏汉霖(02696)发布公告，近日，注射用HLX43(靶向PD-L1抗体偶联药物)(HLX43)联合贝伐珠单抗联合或不联合化疗用于晚期/转移性实体瘤治疗的临床试验申请获国家药品监督管理局批准。本公司拟于条件具备后于中国境内(不包括中国港澳台地区，下同)开展相关临床试验。HLX43是由本公司利用许可引进的新型DNA拓扑异构酶I抑制剂小分子毒素-肽链连接子与本公司自主研发的靶向PD...

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cORR和mPFS分别为33.3%和6.34个月;既往多西他赛治疗失败且接受三线及以上治疗的sqNSCLC患者中(2mg/kg，n=15)，HLX43单药治疗的cORR为46.7%，cDCR为80.0%，mPFS为6.90个月，这一数据显著优于该人群在传统化疗(多西他赛)治疗下的历史缓解率。此外，HLX43治疗在PD-L1阳性(TPS≥1%，n=29)与阴性(TPS<1%或不可评估，n=39)患者的cORR分别为 37.9%与33.3%，cDCR分别达到89.7%和84.6%，无显著差异;PD-L1阳性亚组的mPFS达到6.80个月，PD-L1阴性亚组的mPFS达到5.49个月，该研究结果显示，无论患者PD-L1表达情况如何，HLX43均能提供稳定且高效的治疗选择。在安全性与耐受性方面，值得关注的是，在覆盖不同剂量水平、不同NSCLC亚型及不同治疗背景患者的205例分析人群中，HLX43整体也呈现出一致且良好的安全性特征。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; 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