美股详情

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16.99

-1.3200-7.21%

盘后：16.61-0.3800-2.24%19:11 EDT

成交量：182.80万

成交额：3,119.39万

市值：15.48亿

市盈率：-28.70

高：17.66

开：17.49

低：16.87

收：18.31

数据加载中...

总览公司新闻公告

首款狂犬病双抗在国内报上市、先声再明三抗新药授权艾伯维、默沙东 PD-1 单抗在国内获批新适应症

医药经济报

【默沙东PD-1抑制剂可瑞达在华获批局部晚期或转移性尿路上皮癌治疗适应证】默沙东宣布，其PD-1抑制剂帕博利珠单抗已获得中国国家药品监督管理局批准，联合注射用维恩妥尤单抗用于治疗局部晚期或转移性尿路上皮癌成人患者。此次新适应证获批是基于全球III期临床试验KEYNOTE-A39研究数据。

【君实生物：特瑞普利单抗二线及以上治疗黑色素瘤获国家药监局常规批准】金融界1月6日消息，近日，君实生物的特瑞普利单抗（商品名：拓益®，产品代号：JS001）用于既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗适应症，由附条件批准转为常规批准。该药是中国首个批准上市的以PD-1为靶点的国产单抗药物，至今已在全球开展了超过15个适应症的40多项临床研究。其10项适应症已在中国内地获批，已全部纳入《国家医保目录（2024年）》。2024年10月，用于复发/转移性鼻咽癌治疗的适应症在中国香港获批。在国际化布局方面，该药已在美国、欧盟等多地获批上市，澳大利亚和新加坡也分别受理了相关上市许可申请。但医药产品具高科技、高风险、高附加值特点，商业化情况存在不确定性。

金十数据整理：每日美股市场要闻速递（1月3日周五）

阿斯利康(AZN.US)PD-1/TIGIT双抗启动III期临床

首个国产干细胞注射液附条件批准上市，科伦博泰抗PD-L1单抗新药获批上市，礼来替尔泊肽在华上市，赛诺菲BTK抑制剂在中国申报上市

医药经济报

科伦博泰PD-L1单抗科泰莱获批上市适应症为鼻咽癌

中国网财经

科伦药业：控股子公司抗PD-L1塔戈利单抗获批上市

【科伦药业：控股子公司抗PD-L1塔戈利单抗获批上市】科伦药业1月1日晚间公告，公司控股子公司四川科伦博泰生物医药股份有限公司用于治疗既往接受过2线及以上化疗失败的复发或转移性鼻咽癌患者的靶向程序性细胞死亡配体1的创新人源化单克隆抗体塔戈利单抗已获国家药监局批准于中国上市。

【科伦博泰生物-B(06990.HK)：抗PD-L1塔戈利单抗获国家药监局批准上市】科伦博泰生物-B(06990.HK)发布公告，公司用于治疗既往接受过2线及以上化疗失败的复发或转移性鼻咽癌患者的靶向程序性细胞死亡配体1(PD-L1)的创新人源化单克隆抗体(单抗)塔戈利单抗(前称KL-A167)(科泰莱®)已获中国国家药品监督管理局(NMPA)批准于中国上市。

【研报掘金丨浙商证券：首予恒瑞医药“买入”评级，2025年开始创新+国际化加速】浙商证券研报指出，历史上中国医药行业经历多次政策变化，恒瑞医药(600276.SH)一直保持相对稳健的增速，充分显示公司在政策演变中较强韧性。我们看好在2019-2024 年经历了集采、医保谈判价格波动影响后，公司2025年开始创新+国际化加速，CDK4/6、PD-L1、海曲泊帕、JAK、HER2 ADC、IL-4R、GLP-1等大单品/适应症陆续商业化，驱动公司进入收入增长新一轮加速期，首次覆盖并给予“买入”评级。

【富满微：公司PD类芯片大部分为ASIC架构】富满微12月23日在互动平台表示，公司PD类芯片大部分为ASIC架构，适用于适配器、充电器等，PD类产品系公司主力产品之一。

【百利天恒：GNC-038 四特异性抗体注射液项目治疗系统性红斑狼疮、类风湿关节炎获临床试验批准】金融界12月23日消息，百利天恒近日收到国家药品监督管理局正式批准签发的《药物临床试验批准通知书》，其自主研发的创新生物药GNC-038的药物临床试验获得批准。GNC-038是一种靶向CD3、4-1BB、PD-L1和CD19的创新重组人源化四特异性抗体，是全球首个进入临床开发的四特异性治疗性抗体。除新获批的2个适应症外，目前已开展了1个Ia/Ib期和4个Ib/II期临床研究，适应症为急性淋巴细胞白血病和非霍奇金淋巴瘤等血液系统肿瘤。但药品在获得批准通知书后，尚需开展临床试验并经批准方可生产上市，具有不确定性。

基石药业(02616)重磅产品CS2009（PD-1/VEGF/CTLA-4三抗）在澳大利亚递交临床试验申请

默沙东完成关于在研PD-1/VEGF双特异性抗体LM-299的全球独家许可协议

中颖电子12月18日在互动平台上表示，中颖PD协议芯片将在明年启动市场推广。

日本国立材料研究所廖梅勇团队实现金刚石DUV探测器低电压高增益新突破！

21健讯Daily｜两部门发文完善医药集中带量采购和执行工作机制；默沙东PD-1抑制剂帕博利珠单抗新适应症获批

和誉-B(02256)：口服PD-L1小分子抑制剂ABSK043联合伏美替尼治疗非小细胞肺癌的 II期临床研究完成首例患者给药

默沙东PD-1抑制剂可瑞达在华获批局部晚期宫颈癌治疗适应证

每日经济新闻

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21:19","pubTimestamp":1735910370,"startTime":"0","endTime":"0","summary":"智通财经APP获悉，1月3日，药物临床试验登记与信息公示平台官网显示，阿斯利康(AZN.US)登记了一项 Rilvegostomig 或帕博利珠单抗联合化疗一线治疗转移性非鳞状非小细胞肺癌的全球 III 期研究(CTR20244980)。截图来源：药物临床试验登记与信息公示平台这是一项随机、双盲、多中心、全球、III 期研究，旨在评估 Rilvegostomig 联合化疗与帕博利珠单抗联合化疗相比一线治疗肿瘤表达 PD-L1(TC≥1%)的非鳞状非小细胞肺癌参与者的有效性和安全性。主要终点是 OS 和 PFS。该试验共有 250 家机构参与，国内计划入组132名受试者，国际878名受试者。","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"http://www.zhitongcaijing.com/content/detail/1233372.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"stock_zhitongcaijing","symbols":["III","LU0109394709.USD","AZN","BK4134","LU1169590202.USD","LU2417539215.USD","LU0889565916.HKD","BK4588","PD","BK4585","LU2236285917.USD","BK4023","LU2462157665.USD","LU1829250122.USD","LU1169589451.USD","BK4007","LU0320765992.SGD","LU2456880835.USD","BK4568"],"gpt_icon":0},{"id":"2500784928","title":"首个国产干细胞注射液附条件批准上市，科伦博泰抗PD-L1单抗新药获批上市，礼来替尔泊肽在华上市，赛诺菲BTK抑制剂在中国申报上市","url":"https://stock-news.laohu8.com/highlight/detail?id=2500784928","media":"医药经济报","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2500784928?lang=zh_cn&edition=fundamental","pubTime":"2025-01-02 20:25","pubTimestamp":1735820715,"startTime":"0","endTime":"0","summary":"今日该药获批上市，成为国内同类疗法的一大里程碑。根据科伦博泰公开资料，这是一款抗PD-L1单抗，本次获批的适应症为单药用于既往接受过二线及以上化疗失败的复发或转移性鼻咽癌患者的治疗。赛诺菲BTK抑制剂在中国申报上市！赛诺菲此前新闻稿表示，rilzabrutinib有希望成为首个治疗ITP适应症的BTK抑制剂。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250102202931a212e27e&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, 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适应症为鼻咽癌","url":"https://stock-news.laohu8.com/highlight/detail?id=2500137969","media":"中国网财经","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2500137969?lang=zh_cn&edition=fundamental","pubTime":"2025-01-02 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科伦药业1月1日晚间公告，公司控股子公司四川科伦博泰生物医药股份有限公司用于治疗既往接受过2线及以上化疗失败的复发或转移性鼻咽癌患者的靶向程序性细胞死亡配体1的创新人源化单克隆抗体塔戈利单抗已获国家药监局批准于中国上市。","url":"https://stock-news.laohu8.com/highlight/detail?id=2500409604","media":"金融界","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2500409604?lang=zh_cn&edition=fundamental","pubTime":"2025-01-01 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年经历了集采、医保谈判价格波动影响后，公司2025年开始创新+国际化加速，CDK4/6、PD-L1、海曲泊帕、JAK、HER2 ADC、IL-4R、GLP-1等大单品/适应症陆续商业化，驱动公司进入收入增长新一轮加速期，首次覆盖并给予“买入”评级。","url":"https://stock-news.laohu8.com/highlight/detail?id=2494097688","media":"金融界","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2494097688?lang=zh_cn&edition=fundamental","pubTime":"2024-12-25 13:50","pubTimestamp":1735105819,"startTime":"0","endTime":"0","summary":"浙商证券研报指出，历史上中国医药行业经历多次政策变化，恒瑞医药(600276.SH)一直保持相对稳健的增速，充分显示公司在政策演变中较强韧性。我们看好在2019-2024 年经历了集采、医保谈判价格波动影响后，公司2025年开始创新+国际化加速，CDK4/6、PD-L1、海曲泊帕、JAK、HER2 ADC、IL-4R、GLP-1等大单品/适应症陆续商业化，驱动公司进入收入增长新一轮加速期，首次覆盖并给予“买入”评级。","market":"hk","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://24h.jrj.com.cn/2024/12/25135046788128.shtml","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"jinrongjie_stock","symbols":["600276","PD","601878","600056","ADC","GLP"],"gpt_icon":0},{"id":"2493754039","title":"【富满微：公司PD类芯片大部分为ASIC架构】富满微12月23日在互动平台表示，公司PD类芯片大部分为ASIC架构，适用于适配器、充电器等，PD类产品系公司主力产品之一。","url":"https://stock-news.laohu8.com/highlight/detail?id=2493754039","media":"金融界","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2493754039?lang=zh_cn&edition=fundamental","pubTime":"2024-12-23 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四特异性抗体注射液项目治疗系统性红斑狼疮、类风湿关节炎获临床试验批准】金融界12月23日消息，百利天恒近日收到国家药品监督管理局正式批准签发的《药物临床试验批准通知书》，其自主研发的创新生物药GNC-038的药物临床试验获得批准。GNC-038是一种靶向CD3、4-1BB、PD-L1和CD19的创新重组人源化四特异性抗体，是全球首个进入临床开发的四特异性治疗性抗体。除新获批的2个适应症外，目前已开展了1个Ia/Ib期和4个Ib/II期临床研究，适应症为急性淋巴细胞白血病和非霍奇金淋巴瘤等血液系统肿瘤。但药品在获得批准通知书后，尚需开展临床试验并经批准方可生产上市，具有不确定性。","url":"https://stock-news.laohu8.com/highlight/detail?id=2493734438","media":"金融界","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2493734438?lang=zh_cn&edition=fundamental","pubTime":"2024-12-23 17:56","pubTimestamp":1734947804,"startTime":"0","endTime":"0","summary":"金融界12月23日消息，百利天恒近日收到国家药品监督管理局正式批准签发的《药物临床试验批准通知书》，其自主研发的创新生物药GNC-038的药物临床试验获得批准。GNC-038是一种靶向CD3、4-1BB、PD-L1和CD19的创新重组人源化四特异性抗体，是全球首个进入临床开发的四特异性治疗性抗体。除新获批的2个适应症外，目前已开展了1个Ia/Ib期和4个Ib/II期临床研究，适应症为急性淋巴细胞白血病和非霍奇金淋巴瘤等血液系统肿瘤。但药品在获得批准通知书后，尚需开展临床试验并经批准方可生产上市，具有不确定性。","market":"sh","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://24h.jrj.com.cn/2024/12/23175646706774.shtml","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"jinrongjie_stock","symbols":["159839","BK1576","688506","BK1141","LU1169589451.USD","LU1169590202.USD","PD","BK4023","BK0239","BK1583","03347"],"gpt_icon":0},{"id":"2493271642","title":"基石药业(02616)重磅产品CS2009（PD-1/VEGF/CTLA-4三抗）在澳大利亚递交临床试验申请","url":"https://stock-news.laohu8.com/highlight/detail?id=2493271642","media":"智通财经","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2493271642?lang=zh_cn&edition=fundamental","pubTime":"2024-12-23 08:41","pubTimestamp":1734914492,"startTime":"0","endTime":"0","summary":"智通财经APP获悉，基石药业今日宣布，公司用于治疗多种实体瘤的管线2.0重磅产品CS2009已在澳大利亚递交临床试验申请。此外，基石药业计划于2025年初首先在澳洲启动CS2009的全球多中心、首次人体研究，未来将陆续扩展至中国及美国。CS2009是一款具有创新结构设计的、同时靶向PD-1、VEGFA及CTLA-4的三特异性抗体。CS2009还可以诱导高效内化，从而减少双阳性TILs细胞表面免疫抑制性分子PD-1和CTLA-4的表达。临床前数据显示，CS2009具有明显优于潜在竞品的抗肿瘤活性。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"http://www.zhitongcaijing.com/content/detail/1228187.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"stock_zhitongcaijing","symbols":["BK1576","PD","BK1574","BK1161","03347","LU1169589451.USD","02616","BK4023","LU1169590202.USD","BK1583","BK1141"],"gpt_icon":0},{"id":"2492126744","title":"默沙东完成关于在研PD-1/VEGF双特异性抗体LM-299的全球独家许可协议","url":"https://stock-news.laohu8.com/highlight/detail?id=2492126744","media":"界面","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492126744?lang=zh_cn&edition=fundamental","pubTime":"2024-12-20 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