礼来终止2项口服GLP-1药二期试验

生物药大时代

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声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议礼来在本周ClinicalTrials.gov的更新中传出重磅动态：已正式终止其口服GLP-1受体激动剂naperglipron用于肥胖症治疗的两项中期试验。被终止的试验具体情况如下:（1）试验-NCT07030868：针对同时患有肥胖症或超重以及二型...

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href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250901104047a7084c86&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":"LU2461242641.AUD","symbol_name":"WELLINGTON US QUALITY GROWTH \"A\" (AUDHDG) ACC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250901104047a7084c86&s=b","article_id":"2564862445","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250901104047a7084c86&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=2564862445","pubTimestamp":1756690859,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"不过，备受关注的口服GLP-1药物orforglipron在三期临床中疗效未达预期。HRS9531是一款恒瑞自主研发的GLP-1/GIP双受体激动剂，该药已在中国开展多项临床试验，累计超过2000名受试者接受了治疗。图：恒瑞医药 部分研发管线歌礼制药口服小分子GLP-1激动剂ASC30在美国Ib期MAD队列2经安慰剂校准后的体重相对基线平均下降6.5%。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU2461242641.AUD":"WELLINGTON US QUALITY GROWTH \"A\" (AUDHDG) ACC","LU0417517546.SGD":"Allianz US Equity Cl AT Acc SGD","LU0882574139.USD":"富达环球消费行业基金A ACC","LU2552382132.HKD":"WELLINGTON US BRAND POWER \"A\" (HKD) ACC","LU1868836757.USD":"CT (LUX) I AMERICAN FUND \"2\" (USD) ACC","LU2361044865.SGD":"WELLINGTON US QUALITY GROWTH \"A\" (SGDHDG) ACC","LU2462157665.USD":"ALLIANZ GLOBAL INCOME \"A\" (USD) INC","Y":"Alleghany Corp","LU0640476718.USD":"THREADNEEDLE (LUX) US CONTRARIAN 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drugs","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01276":0.9,"GLP":1,"LLY":1,"Y":0.9},"content_text":"声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议礼来在本周ClinicalTrials.gov的更新中传出重磅动态：已正式终止其口服GLP-1受体激动剂naperglipron用于肥胖症治疗的两项中期试验。被终止的试验具体情况如下:（1）试验-NCT07030868：针对同时患有肥胖症或超重以及二型糖尿病的成年人。（2）试验二NCTO7085468：针对BM介于 22至25之间的成年人，该范围被认为低于超重或肥胖的阈值。礼来2025营收预期指引上调礼来2025半年报近日出炉，其年报提到市场需求依然强劲，但对口服减肥产品的疗效提出了更高要求。公司上半年表现亮眼，增速大幅超出预期。第二季度实现收入155.58亿美元，同比增长38%，其中替尔泊肽（Tirzepatide）表现尤为突出，单季销售额达85.8亿美元，同比大涨98%，成为当之无愧的全球“药王”。2025年H1总营收282.86亿美元，同比增长40.93%，营收表现还是非常强劲的。其中研发投入60.7亿美元，同比增长15.97%。基于这一强劲增长，礼来上调了全年营收预期至600-620亿美元，较此前预估中值上调约15亿美元。不过，备受关注的口服GLP-1药物orforglipron在三期临床中疗效未达预期。结果显示，治疗72周后平均减重仅为11.2%，相比其二期数据36周减重9.4%-14.7%，呈现明显回落，疗效未能延续早期优势。研发管线布局研发一直是各企业的核心，关系未来的竞争布局，截止第二季度报告显示，其核心聚焦代谢、神经、肿瘤与自免领域，多款重磅产品引领创新。作为全球医药研发的领军企业，在代谢疾病领域，降糖与减重治疗占据领导地位，核心产品替尔泊肽已获批用于2型糖尿病和肥胖症治疗，并仍在扩展其他代谢相关适应症。神经科学领域重点攻坚阿尔茨海默病，Donanemab是抗Aβ单抗，用于早期阿尔茨海默病，已在美国和欧盟提交上市申请。肿瘤领域聚焦靶向与免疫治疗，BTK抑制剂Pirtobrutinib用于血液肿瘤，已获美国FDA批准上市。自身免疫疾病方面IL-13抑制剂与炎症通路新靶点，Lebrikizumab抗IL-13单抗，用于特应性皮炎，已在部分国家提交注册申请等等。图：礼来业绩公告礼来整体管线兼具深度与广度，且多数后期产品具备重磅炸弹潜力，预计未来几年将持续推动业绩增长和临床价值提升。国内布局降糖减重市场提升，跨国药企对引进疗效更优口服减肥药的需求进一步上升。目前国内布局口服小分子减肥药的企业包括恒瑞医药、歌礼制药、华东医药等，另外还有乐普医疗（民为生物）、博瑞医药、联邦制药等企业也致力于口服多肽类药物的研发。恒瑞医药与Kailera Therapeutics共同宣布GLP-1/GIP双重受体激动剂HRS9531注射液在针对中国肥胖或超重人群的关键III期临床试验（HRS9531-301）中取得全面积极的顶线结果。HRS9531是一款恒瑞自主研发的GLP-1/GIP双受体激动剂，该药已在中国开展多项临床试验，累计超过2000名受试者接受了治疗。图：恒瑞医药 部分研发管线歌礼制药口服小分子GLP-1激动剂ASC30在美国Ib期MAD队列2经安慰剂校准后的体重相对基线平均下降6.5%。目前ASC30在美国IIa期临床已完成入组，有望在年内获得顶线数据。图：歌礼制药 研发管线HDM1002是华东医药自主研发的具有口服活性、强效、高选择性的胰高血糖素样肽-1受体（GLP-1R）小分子完全激动剂，减重Ⅱ期研究结果表现良好，减重和降糖适应症均已进入中国Ⅲ期临床研究阶段，其中减重适应症已经完成Ⅲ期临床所有受试者入组。图：华东医药 部分研发管线歌礼、恒瑞、华东等国内企业研发管线百花齐放，覆盖口服小分子、多肽类药物等多种技术路径，多样化布局为MNC进入中国减肥药市场提供了更多窗口机会。未来跨国药企与国内企业之间的引进或合作可能性预计将进一步增加。参考来源：www.lilly.comwww.hengrui.comwww.ascletis.comwww.eastchinapharm.com","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}