辉瑞(PFE.US)PD-L1靶向ADC新药在华获批临床拟治疗晚期实体瘤

智通财经

11 Mar

智通财经APP获悉，3月10日，中国国家药监局药品审评中心(CDE)官网最新公示，辉瑞(PFE.US)公司旗下Seagen申报的1类新药PF-08046054(注射用冻干粉针)获得临床试验默示许可，拟开发治疗转移性或不可切除的晚期实体瘤。公开资料显示，这是辉瑞在研的一款潜在“first-in-class”PD-L1靶向抗体偶联药物(ADC)。

截图来源：CDE官网

根据辉瑞公开资料介绍，PF-08046054(又称SGN-PDL1V、PDL1V)是一款靶向PD-L1的ADC，由抗PD-L1抗体、连接子和微管破坏剂MMAE(monomethyl auristatin E)组成，可通过直接细胞毒性、旁观者杀伤、免疫原性细胞死亡来发挥抗肿瘤活性。在临床前研究中，这款ADC产品在PD-L1低表达或表达异质性高的动物模型中也展现出抗癌活性。

在2024年欧洲肿瘤内科学会(ESMO)大会上，研究人员公布了PF-08046054的1期临床中期结果(SGNPDL1V-001研究)。

截至2024年3月6日，55名患者接受了治疗，中位年龄为60岁(范围24-72岁)。未见剂量限制性毒性(DLT);1.75 mg/kg为评价的最高剂量。最常见的治疗相关不良事件(TRAEs)为周围感觉神经病变、乏力、疲劳和恶心，大多数患者的严重程度为1-2级。有效性方面，研究者评估的所有剂量和肿瘤类型的客观缓解率(ORR)为27.3%(确定的ORR为12.7%)，确定应答的中位持续时间为7.9个月。从1.25 mg/kg剂量开始观察到客观反应，且与PD-L1表达无关。

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One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2518980763"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2518980763\",edition:\"fundamental\",,,undefined,":{"share":"https://ttm.financial/m/news/2518980763?lang=en_US&edition=fundamental","thumbnail":"","is_english":false,"pubTime":"2025-03-11 14:10","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2518980763","market":"hk","top_or_hot":-1,"title":"辉瑞(PFE.US)PD-L1靶向ADC新药在华获批临床 拟治疗晚期实体瘤","media":"智通财经","content":"<html><body><p>智通财经APP获悉，3月10日，中国国家药监局药品审评中心(CDE)官网最新公示，<a href=\"https://laohu8.com/S/PFE\">辉瑞</a>(PFE.US)公司旗下<a href=\"https://laohu8.com/S/SGEN\">Seagen</a>申报的1类新药PF-08046054(注射用冻干粉针)获得临床试验默示许可，拟开发治疗<strong>转移性或不可切除的晚期实体瘤</strong>。公开资料显示，这是辉瑞在研的一款潜在“first-in-class”<strong>PD-L1靶向抗体偶联药物(ADC)</strong>。</p><center><img height=\"80\" src=\"http://img.zhitongcaijing.com/images/contentformat/c71fc10001b0759942e564dfd4372bad.jpg\" width=\"677\"/></center><p>截图来源：CDE官网</p><p>根据辉瑞公开资料介绍，PF-08046054(又称SGN-PDL1V、PDL1V)是一款靶向PD-L1的ADC，<strong>由抗PD-L1抗体、连接子和微管破坏剂MMAE(monomethyl auristatin E)组成，可通过直接细胞毒性、旁观者杀伤、免疫原性细胞死亡来发挥抗肿瘤活性。</strong>在临床前研究中，这款ADC产品在PD-L1低表达或表达异质性高的动物模型中也展现出抗癌活性。</p><p>在2024年欧洲肿瘤内科学会(ESMO)大会上，研究人员公布了PF-08046054的1期临床中期结果(SGNPDL1V-001研究)。</p><p>截至2024年3月6日，55名患者接受了治疗，中位年龄为60岁(范围24-72岁)。未见剂量限制性毒性(DLT);1.75 mg/kg为评价的最高剂量。最常见的治疗相关不良事件(TRAEs)为周围感觉神经病变、乏力、疲劳和恶心，大多数患者的严重程度为1-2级。有效性方面，<strong>研究者评估的所有剂量和肿瘤类型的客观缓解率(ORR)为27.3%(确定的ORR为12.7%)，确定应答的中位持续时间为7.9个月。</strong>从1.25 mg/kg剂量开始观察到客观反应，且与PD-L1表达无关。</p></body></html>","source":"stock_zhitongcaijing","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta 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href=http://www.zhitongcaijing.com/content/detail/1260252.html><strong>智通财经</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>智通财经APP获悉，3月10日，中国国家药监局药品审评中心(CDE)官网最新公示，辉瑞(PFE.US)公司旗下Seagen申报的1类新药PF-08046054(注射用冻干粉针)获得临床试验默示许可，拟开发治疗转移性或不可切除的晚期实体瘤。公开资料显示，这是辉瑞在研的一款潜在“first-in-class”PD-L1靶向抗体偶联药物(ADC)。截图来源：CDE官网根据辉瑞公开资料介绍，PF-...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1260252.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0306807586.USD","symbol_name":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" (USD) INC 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