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spring0305
2025-12-22
$翰思艾泰-B(03378)$
有点恶心
spring0305
2025-12-12
12月12日，四川科伦博泰的注射用A166收到药监局的通知件，正式宣告其上市申请未获批准（新适应症）。
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16:36","market":"hk","language":"zh","title":"国产之光，科伦博泰HER2 ADC突围二线及以上全人群HER2阳性乳腺癌","url":"https://stock-news.laohu8.com/highlight/detail?id=2590085555","media":"药械Talks","summary":"根据获批适应症，博度曲妥珠单抗将用于既往接受过一种或一种以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌患者。虽然在博度曲妥珠单抗之前，已有两款国产HER2 ADC拿到上市许可。所以，博度曲妥珠单抗是首个真正意义上实现HER2阳性乳腺癌二线及以上治疗全面覆盖的国产HER2 ADC。要进一步说明的是，在博度曲妥珠单抗进行NDA申报的过程中，先后提交了两个适应症申请：分别针对三线及以上，以及二线及以上HER2阳性乳腺癌。","content":"<html><body><article><p>10月17日，<a href=\"https://laohu8.com/S/06990\">科伦博泰</a>宣布其自主研发的HER2靶向ADC药物——博度曲妥珠单抗（A166，舒泰莱®）正式获批上市，成为继TROP2 ADC之后，该公司获批的第二款ADC产品。</p><p>此次获批不仅是科伦博泰在ADC领域持续深耕、不断突破的有力见证，更是国产ADC在HER2阳性晚期乳腺癌治疗这一关键战场上实现“全面突围”的重要里程碑。根据获批适应症，博度曲妥珠单抗将用于既往接受过一种或一种以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌患者。这一关键突破无疑弥补了该适应症国产HER2 ADC缺位的遗憾。</p><p>虽然在博度曲妥珠单抗之前，已有两款国产HER2 ADC拿到上市许可。然而，维迪西妥单抗适应症为存在肝转移的HER2阳性晚期乳腺癌人群，另一款瑞康曲妥珠单抗则获批于非小细胞肺癌。所以，博度曲妥珠单抗是首个真正意义上实现HER2阳性乳腺癌二线及以上治疗全面覆盖的国产HER2 ADC。</p><p>要进一步说明的是，在博度曲妥珠单抗进行NDA申报的过程中，先后提交了两个适应症申请：分别针对三线及以上，以及二线及以上HER2阳性乳腺癌。最终，监管部门批准其覆盖二线及以上的整体人群，意味着无论患者处于二线还是更晚的治疗阶段，都能从这款药物中获益。一次性打通适应症壁垒，也使得博度曲妥珠单抗在临床应用上更具广度和实用价值。</p><p>乳腺癌是严重威胁全世界<a href=\"https://laohu8.com/S/FHCO\">女性健康</a>的第一大恶性肿瘤。在每年新发乳腺癌病例中，约3%~10%的妇女在确诊时即有远处转移，早期患者中也有约30%最终发展为晚期乳腺癌。对于这些患者而言，5年生存率仅为20%，形势严峻程度可见一斑。而HER2阳性乳腺癌约占全部乳腺癌的20%~30%，还具有侵袭性强、复发风险高，预后较差的特点。</p><p>近年来，HER2 ADC已成为改善这类患者生存的重要武器。此前国内针对HER2阳性乳腺癌全人群的二线及以上治疗，仅有两款进口ADC药物可供使用，即罗氏的T-DM1（恩美曲妥珠单抗）以及第一三共/<a href=\"https://laohu8.com/S/AZN\">阿斯利康</a>的T-DXd（德曲妥珠单抗）。但这两款药物也并非“完美解法”，T-DM1的疗效改善有限，而T-DXd虽然凭借DESTINY-Breast 03研究的优异数据一度取代T-DM1成为新的二线标准，但部分患者因安全性问题仍无法获益。</p><p>由此可见，在这一HER2 ADC最大的适应症上，临床实践中依然存在着较大的未满足需求。</p><p>博度曲妥珠单抗的获批，为这类患者提供了重要的国产解决方案。它是首个在头对头III期研究中与T-DM1直接比较，并取得阳性结果的国产HER2 ADC，以硬核数据证明了自身的竞争力。</p><p>本次批准是基于Ⅲ期KL166-III-06研究的结果——这是一项多中心、随机、开放、对照的临床研究，直接对比博度曲妥珠单抗与T-DM1在既往接受过曲妥珠单抗和紫杉类治疗的HER2阳性不可切除或转移性乳腺癌患者中的疗效和安全性。期中分析数据显示，与T-DM1相比，博度曲妥珠单抗单药在主要研究终点，盲态独立中心评估（BICR）评估的无进展生存期（PFS）方面，具有显著统计学意义和临床意义的改善。</p></article></body></html>","source":"tencent","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>国产之光，科伦博泰HER2 ADC突围二线及以上全人群HER2阳性乳腺癌</title>\n<style 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}\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n国产之光，科伦博泰HER2 ADC突围二线及以上全人群HER2阳性乳腺癌\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-12-12 16:36 北京时间 <a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251212164453a4446707&s=b><strong>药械Talks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>10月17日，科伦博泰宣布其自主研发的HER2靶向ADC药物——博度曲妥珠单抗（A166，舒泰莱®）正式获批上市，成为继TROP2 ADC之后，该公司获批的第二款ADC产品。此次获批不仅是科伦博泰在ADC领域持续深耕、不断突破的有力见证，更是国产ADC在HER2阳性晚期乳腺癌治疗这一关键战场上实现“全面突围”的重要里程碑。根据获批适应症，博度曲妥珠单抗将用于既往接受过一种或一种以上抗HER2药物...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251212164453a4446707&s=b\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BK1161":"生物科技","LU0196878994.USD":"MANULIFE GF CHINA VALUE \"AA\" (USD) INC","06990":"科伦博泰生物-B"},"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251212164453a4446707&s=b","is_english":false,"share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","article_id":"2590085555","content_text":"10月17日，科伦博泰宣布其自主研发的HER2靶向ADC药物——博度曲妥珠单抗（A166，舒泰莱®）正式获批上市，成为继TROP2 ADC之后，该公司获批的第二款ADC产品。此次获批不仅是科伦博泰在ADC领域持续深耕、不断突破的有力见证，更是国产ADC在HER2阳性晚期乳腺癌治疗这一关键战场上实现“全面突围”的重要里程碑。根据获批适应症，博度曲妥珠单抗将用于既往接受过一种或一种以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌患者。这一关键突破无疑弥补了该适应症国产HER2 ADC缺位的遗憾。虽然在博度曲妥珠单抗之前，已有两款国产HER2 ADC拿到上市许可。然而，维迪西妥单抗适应症为存在肝转移的HER2阳性晚期乳腺癌人群，另一款瑞康曲妥珠单抗则获批于非小细胞肺癌。所以，博度曲妥珠单抗是首个真正意义上实现HER2阳性乳腺癌二线及以上治疗全面覆盖的国产HER2 ADC。要进一步说明的是，在博度曲妥珠单抗进行NDA申报的过程中，先后提交了两个适应症申请：分别针对三线及以上，以及二线及以上HER2阳性乳腺癌。最终，监管部门批准其覆盖二线及以上的整体人群，意味着无论患者处于二线还是更晚的治疗阶段，都能从这款药物中获益。一次性打通适应症壁垒，也使得博度曲妥珠单抗在临床应用上更具广度和实用价值。乳腺癌是严重威胁全世界女性健康的第一大恶性肿瘤。在每年新发乳腺癌病例中，约3%~10%的妇女在确诊时即有远处转移，早期患者中也有约30%最终发展为晚期乳腺癌。对于这些患者而言，5年生存率仅为20%，形势严峻程度可见一斑。而HER2阳性乳腺癌约占全部乳腺癌的20%~30%，还具有侵袭性强、复发风险高，预后较差的特点。近年来，HER2 ADC已成为改善这类患者生存的重要武器。此前国内针对HER2阳性乳腺癌全人群的二线及以上治疗，仅有两款进口ADC药物可供使用，即罗氏的T-DM1（恩美曲妥珠单抗）以及第一三共/阿斯利康的T-DXd（德曲妥珠单抗）。但这两款药物也并非“完美解法”，T-DM1的疗效改善有限，而T-DXd虽然凭借DESTINY-Breast 03研究的优异数据一度取代T-DM1成为新的二线标准，但部分患者因安全性问题仍无法获益。由此可见，在这一HER2 ADC最大的适应症上，临床实践中依然存在着较大的未满足需求。博度曲妥珠单抗的获批，为这类患者提供了重要的国产解决方案。它是首个在头对头III期研究中与T-DM1直接比较，并取得阳性结果的国产HER2 ADC，以硬核数据证明了自身的竞争力。本次批准是基于Ⅲ期KL166-III-06研究的结果——这是一项多中心、随机、开放、对照的临床研究，直接对比博度曲妥珠单抗与T-DM1在既往接受过曲妥珠单抗和紫杉类治疗的HER2阳性不可切除或转移性乳腺癌患者中的疗效和安全性。期中分析数据显示，与T-DM1相比，博度曲妥珠单抗单药在主要研究终点，盲态独立中心评估（BICR）评估的无进展生存期（PFS）方面，具有显著统计学意义和临床意义的改善。","news_type":1,"symbols_score_info":{"06990":0.9}},"isVote":1,"tweetType":1,"viewCount":290,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0}],"lives":[]}
