康方生物OS data improved with longer follow-up

招银国际

09/10

一、核心观点与数据更新本报告主要围绕Akeso(9926HK)的全球HARMONi试验数据展开分析，特别是AK112联合化疗在二线治疗3代EGFR-TKI耐药非小细胞肺癌(NSCLC)中的表现。数据显示，在更长的随访中，总生存期(OS)有所改善，但西方患者的无进展生存期(PFS)和OS的风险比(HR)略逊于中国患者。研究者认为，这种差异可能部分归因于西方患者随访时间较短，尤其是欧洲患者。尽管最终...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025091011405397847f4d&s=b><strong>招银国际</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>一、核心观点与数据更新本报告主要围绕Akeso(9926HK)的全球HARMONi试验数据展开分析，特别是AK112联合化疗在二线治疗3代EGFR-TKI耐药非小细胞肺癌(NSCLC)中的表现。数据显示，在更长的随访中，总生存期(OS)有所改善，但西方患者的无进展生存期(PFS)和OS的风险比(HR)略逊于中国患者。研究者认为，这种差异可能部分归因于西方患者随访时间较短，尤其是欧洲患者。尽管最终...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025091011405397847f4d&s=b\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1161","symbol_name":"生物科技","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025091011405397847f4d&s=b","article_id":"2566629576","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025091011405397847f4d&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2566629576","pubTimestamp":1757474672,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"研究者认为，这种差异可能部分归因于西方患者随访时间较短，尤其是欧洲患者。此外，北美和欧洲患者的PFS HR为0.67，而中国患者为0.55。北美患者尤其表现出积极结果，其OS HR为0.70。当前，该领域竞争加剧，包括TROP2ADC、HER3ADC等新型疗法正在崛起。未来，投资者可关注中国HARMONi-6研究及HARMONi-2研究的进一步OS更新。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK1161":"生物科技","LU1720050803.USD":"安联全方位中国股票基金","LU0634319403.HKD":"ALLIANZ HONG KONG EQUITY \"AT\" (HKD) ACC","LU0348767384.USD":"ALLIANZLITTLE DRAGONS \"A\" (USD) ACC","LU2476274308.USD":"ALLIANZ CHINA FUTURE TECHNOLOGIES \"AT\" (USD) ACC","LU0348825331.USD":"ALLIANZ CHINA EQUITY \"A\" (USD) INC","09926":"康方生物","LU0348766576.USD":"ALLIANZ LITTLE DRAGONS \"A\" (USD) INC","LU1794554557.SGD":"Allianz All China Equity AT Acc H2-SGD","BK1574":"生物医药B类股","LU2778985437.USD":"ALLIANZ 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following-up","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"09926":1},"content_text":"一、核心观点与数据更新本报告主要围绕Akeso(9926HK)的全球HARMONi试验数据展开分析，特别是AK112联合化疗在二线治疗3代EGFR-TKI耐药非小细胞肺癌(NSCLC)中的表现。数据显示，在更长的随访中，总生存期(OS)有所改善，但西方患者的无进展生存期(PFS)和OS的风险比(HR)略逊于中国患者。研究者认为，这种差异可能部分归因于西方患者随访时间较短，尤其是欧洲患者。尽管最终OS分析未达到FDA要求的显著性阈值(p=0.0448)，但在延长随访后，OS趋势仍呈正向。二、临床数据解读在主要PFS分析中(中位随访时间为22.3个月)，AK112联合化疗的中位PFS为6.8个月，显著优于单纯化疗组的4.4个月(HR=0.52，p<0.001)。然而，在更长随访(中位随访29.7个月)中，PFS HR从0.52略微恶化至0.57，主要是由于西方亚组数据成熟度增加所致。此外，北美和欧洲患者的PFS HR为0.67，而中国患者为0.55。在OS方面，最终分析显示AK112联合化疗组的中位OS为16.8个月，对照组为14.0个月(HR=0.79，p=0.0570)，虽未达显著性阈值，但延长随访后OS HR进一步改善至0.78(p=0.0332)。北美患者尤其表现出积极结果，其OS HR为0.70。三、市场潜力与竞争格局尽管AK112在二线EGFR突变NSCLC市场的长期销售潜力占比不足5%，但其主要价值在于一线NSCLC治疗。当前，该领域竞争加剧，包括TROP2ADC、HER3ADC等新型疗法正在崛起。因此，AK112需要在疗效和安全性上保持优势以巩固其市场地位。未来，投资者可关注中国HARMONi-6研究(预计在ESMO2025发布)及HARMONi-2研究的进一步OS更新。四、投资建议基于HARMONi试验的积极OS趋势，分析师维持对Akeso的“买入”评级，并对其DCF模型目标价保持不变，为每股182.12港元。这一估值反映了对公司一线适应症潜力的信心，同时也考虑了市场竞争风险和公司财务预测。","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":0,"need_auth":false,"code":"91000000","status":"200"}}}