国内首个！复星医药乙肝siRNA注射液获批临床

市场资讯2022-09-23

9月22日，复星医药旗下公司星曜坤泽宣布，其先导产品HT-101注射液用于治疗慢性乙型肝炎病毒感染（CHB）的临床试验申请（IND）获得了CDE批准。HT-101是一款GalNAc（?N-乙酰半乳糖胺）偶联的siRNA创新药物实体，其成为了国内首个进入临床阶段的GalNAc偶联的siRNA乙肝产品，将为乙肝这一庞大的患者群体，提供“中国创造”的治疗方案。目前，慢性乙肝临床一线最主要的药物是核苷...

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Fosun Pharma Hepatitis B siRNA Injection Approved for Clinical Application","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"600196":1,"02196":1},"content_text":"9月22日，复星医药旗下公司星曜坤泽宣布，其先导产品HT-101注射液用于治疗慢性乙型肝炎病毒感染（CHB）的临床试验申请（IND）获得了CDE批准。HT-101是一款GalNAc（?N-乙酰半乳糖胺）偶联的siRNA创新药物实体，其成为了国内首个进入临床阶段的GalNAc偶联的siRNA乙肝产品，将为乙肝这一庞大的患者群体，提供“中国创造”的治疗方案。目前，慢性乙肝临床一线最主要的药物是核苷类药物，如拉米夫定、恩替卡韦、阿德福韦、替比夫定和丙酚替诺福韦。这一类药物的作用机理是借助乙肝病毒（ HBV ）逆转录酶整合嵌入病毒 DNA，导致 DNA 链复制终止，从而降低HBV DNA。核苷类药物虽然能有效地控制病情，但一旦停药病毒就可能反弹，不能清除病毒，且需每日服用，病人的依从性差。目前，临床上尚无治疗手段可以实现乙肝的功能性治愈乃至完全治愈，乙肝领域目前尚存在巨大的未满足临床需求。因此，开发出可实现乙肝功能性治愈的药物，有望解决广大病患的迫切需求。RNAi（RNA interfere，RNA干扰）技术的出现，为实现乙肝的功能性治愈，提供了强有力的工具。基于RNAi的siRNA（small interfering RNA，小干扰RNA）和ASO（antisense oligonucleotide，反义寡核苷酸），为目前最重要的两种RNAi药物形式。HT-101在临床前药效试验中，仅单次给药，就可降低乙肝病毒多种关键成分的表达，并持续抑制病毒复制超过70天。在可预见的未来的临床研究中，这将大大减少患者的给药频次，从而提高治疗的依从性，同时也会降低治疗成本。此外，星曜坤泽还布局了针对乙肝S抗原的中和抗体HT-102。HT-102在AAV-HBV小鼠模型的药效试验中显示出了明显的抑制S抗原的活性，与HT-101的联用也显示出良好的协同效应。HT-102已完成大部分临床前工作，计划在2022年内提交IND申请，并考虑临床试验中采用siRNA加中和抗体的联合或序贯治疗方案。需要指出的是，siRNA加中和抗体的组合为国内首创。两者联合用药，将大幅拓展受众群体，可以涵盖更广和病毒载量更高的乙肝患者。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":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; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2269641356","isCrawlerRequest":true}