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港股
详情
本页面由Tiger Fintech (Singapore) Pte. Ltd.提供服务
信达生物
46.150
-2.200
-4.55%
手动刷新
成交量:
1,725.86万
成交额:
7.99亿
市值:
760.55亿
市盈率:
-747.54
高:
48.150
开:
48.000
低:
45.450
收:
48.350
数据加载中...
总览
公司
新闻
公告
港股概念追踪|百济神州成为国内“创新药一哥” 机构看好创新药2025年估值修复(附概念股)
智通财经
·
02-26
【港股异动 | 信达生物(01801.HK)午后涨超7% 】信达生物(01801.HK)午后涨超7%,截至发稿,涨5.82%,报42.7港元,成交额4.37亿港元。
金融界
·
02-26
港股异动 | 信达生物(01801)午后涨超7% 信迪利单抗癌症联合疗法申报上市 新药IBI3002获批临床
智通财经
·
02-26
信达生物(01801)出现大手买入48.95万股,成交价$42.7,涉资2.09千万
阿斯达克财经
·
02-26
信达生物盘中异动 快速拉升5.08%
市场透视
·
02-26
招银国际:内地药品价格政策有望优化 医疗AI加速商业化落地
智通财经
·
02-25
21健讯Daily|信达生物新药上市申请获受理并纳入优先审评;爱美客董事拟减持股份
21世纪经济报道
·
02-25
华东医药GLP-1类双靶点新药,信达生物双抗1类新药获批临床
医药经济报
·
02-24
【券商聚焦】中信建投:政策与技术齐驱 我国创新药行业竞争力不断攀升
金吾财讯
·
02-24
信达生物新药上市申请获得受理
财中社
·
02-24
信达生物(01801.HK)伊匹木单抗注射液新药上市申请获内地受理并纳入优先审评程序
阿斯达克财经
·
02-24
信达生物PD-1联合疗法申报上市获受理;艾美疫苗全面接入DeepSeek大模型
每日经济新闻
·
02-24
信达生物宣布首个中国研发的CTLA-4单抗伊匹木单抗注射液联合信迪利单抗用于结肠癌新辅助治疗的新药上市申请获受理并纳入优先审评
美通社
·
02-24
信达生物:伊匹木单抗注射液联合信迪利单抗用于结肠癌新辅助治疗的新药上市申请获国家药品监督管理局受理并纳入优先审评
每日经济新闻
·
02-24
【信达生物(01801.HK):伊匹木单抗注射液联合信迪利单抗用于结肠癌新辅助治疗的新药上市申请获国家药品监督管理局受理并纳入优先审评】信达生物(01801.HK)公布,伊匹木单抗注射液(抗细胞毒T淋巴细胞相关抗原4(CTLA-4单抗,研发代号:IBI310)联合信迪利单抗用于可切除的微卫星高度不稳定型(MSI-H)或错配修复缺陷型(dMMR)结肠癌患者的新辅助治疗的新药上市申请(NDA)已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)受理并纳入优先审评程序。伊匹木单抗是首个递交NDA的中国研发的CTLA-4单抗,同时,这也是信迪利单抗奠定其肿瘤免疫治疗领先品牌的又一里程碑。
金融界
·
02-24
信达生物(01801):伊匹木单抗注射液联合信迪利单抗用于结肠癌新辅助治疗的新药上市申请获国家药品监督管理局受理并纳入优先审评
智通财经
·
02-24
信达生物信迪利单抗癌症联合疗法申报上市,科济药业CAR-T细胞疗法拟纳入突破性治疗品种
医药经济报
·
02-22
信达生物奔跑200亿 俞德超进阶路上的是与非
投资者网
·
02-21
港股异动 | 信达生物(01801)涨超5% AI技术驱动医药板块发展 中金料其有望染蓝
智通财经
·
02-21
信达生物(01801)股价上升5.089%,现价港币$41.3
阿斯达克财经
·
02-21
更多
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13:53","pubTimestamp":1740549201,"startTime":"0","endTime":"0","summary":"2月21日,百济神州以27亿元市值差距超越恒瑞医药,成为“创新药一哥”。百济神州的创新药收入增长迅猛,其BTK抑制剂泽布替尼全球销售额突出。百济神州市值新高有业绩支撑,预计2025年全年经营利润为正。国金证券发布研究报告称,建议继续贯彻AI医药+创新药2025年医药投资两大布局主线。该行表示,看好行业估值修复。","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/1254498.html","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":"stock_zhitongcaijing","symbols":["LU2328871848.SGD","01801","HSCEI","159992","IE00BPRC5H50.USD","BK0239","LU1794554557.SGD","HSTECH","LU0588546209.SGD","BK1574","LU2488822045.USD","IE00B5MMRT66.SGD","BK1589","IE00B543WZ88.USD","688235","LU0348783233.USD","BK4139","BK1588","06978","YANG","09926","BK1161","BK1500","BK1583","LU0307460666.USD","LU0417516571.SGD","LU1720050803.USD","06160","ONC","LU1969619763.USD","LU0348784397.USD"],"gpt_icon":1},{"id":"2514707020","title":"【港股异动 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09:50","pubTimestamp":1740448233,"startTime":"0","endTime":"0","summary":"智通财经APP获悉,招银国际发布研报称,维持内地医药行业“优于大市评级”。MSCI中国医疗指数2025年初至今累计上涨11.5%,跑输MSCI中国指数1.2%。受益于国内药品价格政策优化、国内宏观环境改善以及海外降息预期,医药行业有望在2025年继续迎来估值修复。报告指,丙类医保目录年内即将落地,创新药将覆盖获得更好的支付环境;医疗设备招标加速复苏,将推动国产医疗设备企业盈利复苏。该行看好行业估值修复,推荐买入信达生物(01801)、百济神州(06160)、三生制药(01530)、联影医疗(688271.SH)、巨子生物(02367)、药明康德(02359)、科伦博泰生物-B(06990)。","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/1253807.html","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":"stock_zhitongcaijing","symbols":["01801","LU1969619763.USD","BK1207","BK1593","BK1576","02367","150261","02359","BK1588","LU2242644610.SGD","LU2045819591.USD","LU0307460666.USD","LU0708995583.HKD","BK1589","BK1583","LU0320764599.SGD","BK1500","LU0588546209.SGD","LU0052750758.USD","06160","LU2328871848.SGD","LU1046422090.SGD","01530","LU2125910500.SGD","LU2488822045.USD","BK1161","BK1141"],"gpt_icon":0},{"id":"2514084821","title":"21健讯Daily|信达生物新药上市申请获受理并纳入优先审评;爱美客董事拟减持股份","url":"https://stock-news.laohu8.com/highlight/detail?id=2514084821","media":"21世纪经济报道","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514084821?lang=zh_cn&edition=fundamental","pubTime":"2025-02-25 09:36","pubTimestamp":1740447383,"startTime":"0","endTime":"0","summary":"政策动向成都市促进生物医药产业高质量发展政策近日,成都市政府发布《成都市促进生物医药产业高质量发展若干政策措施》,从支持药械研发创新、提高临床研究质效、支持产品临床应用、支持企业发展壮大、构建完善产业生态5个方面提出25条政策措施。例如,对1类创新药的研发给予最高700万元的奖励,并支持布局细胞与基因治疗、脑科学与脑机接口、AI+生物医药等领域。","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"stock_eastmoney","url":"http://finance.eastmoney.com/a/202502253328591095.html","rn_cache_url":null,"directOrigin":true},"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"http://finance.eastmoney.com/a/202502253328591095.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"stock_eastmoney","symbols":["BK1583","01801","BK1589","LU2328871848.SGD","LU2488822045.USD","LU1969619763.USD","BK1161"],"gpt_icon":0},{"id":"2513048778","title":"华东医药GLP-1类双靶点新药,信达生物双抗1类新药获批临床","url":"https://stock-news.laohu8.com/highlight/detail?id=2513048778","media":"医药经济报","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513048778?lang=zh_cn&edition=fundamental","pubTime":"2025-02-24 21:26","pubTimestamp":1740403589,"startTime":"0","endTime":"0","summary":"华东医药GLP-1类双靶点新药再获批两项临床今日,中国国家药监局药品审评中心官网最新公示,华东医药1类新药HDM1005注射液获得两项新的临床试验默示许可,拟开发用于阻塞性睡眠呼吸暂停合并肥胖或超重成人患者的治疗。公开资料显示,HDM1005是华东医药在研的一款多肽类GLP-1受体和GIP受体的双靶点激动剂,此前已经在中国和美国获得过多项IND。相关数据显示,高达10%的成人哮喘患者和2.5%的儿童哮喘患者患有重度哮喘。","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250224233155a25222fe&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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09:18","pubTimestamp":1740359916,"startTime":"0","endTime":"0","summary":"该行表示,我国创新药行业在全球的竞争力正不断攀升。国家政策大力鼓励创新药发展,新技术的涌现也推动着行业快速前行,出海迎来了全新契机,基于此,该行对创新药行业的前景保持持续乐观的态度。","market":"hk","thumbnail":"https://static.szfiu.com/news/20250109/MWU1MjY1NDI2Mjg5NDIzOQ==.jpg","type":0,"news_type":0,"thumbnails":["https://static.szfiu.com/news/20250109/MWU1MjY1NDI2Mjg5NDIzOQ==.jpg"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"1953707","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU1226287792.SGD","IE00BZ08YR35.GBP","LU2488822045.USD","03692","LU1226288170.HKD","IE00B5MMRT66.SGD","LU1008478684.HKD","LU2328871848.SGD","IE00B543WZ88.USD","LU1807302812.USD","BK1587","LU0326950275.SGD","LU0348783233.USD","00013","LU1951186391.HKD","LU1960683339.HKD","06160","LU0501845795.SGD","LU1720050803.USD","BK1589","01801","BK1500","LU1969619763.USD","LU0588546209.SGD","LU0067412154.USD","01177","LU0307460666.USD","LU1226287529.USD","06978","159992","LU1226287875.USD","01093","IE0008369823.USD","IE00B031HY20.USD","LU0072913022.USD","BK1521","IE0008368742.USD","LU1152091168.USD","601066","BK1191","IE00BZ08YT58.USD","LU1993786604.SGD","BK1583","LU1226288253.USD","LU1152091754.HKD","09926","LU0880133367.SGD","SG9999004220.SGD","BK1574","BK1161"],"gpt_icon":0},{"id":"2513946762","title":"信达生物新药上市申请获得受理","url":"https://stock-news.laohu8.com/highlight/detail?id=2513946762","media":"财中社","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513946762?lang=zh_cn&edition=fundamental","pubTime":"2025-02-24 09:09","pubTimestamp":1740359367,"startTime":"0","endTime":"0","summary":"2月24日,信达生物(01801)发布公告,宣布伊匹木单抗注射液联合信迪利单抗用于结肠癌的新辅助治疗的新药上市申请已获得中国国家药品监督管理局受理,并纳入优先审评程序。该药物的研发代号为IBI310,是首个递交NDA的中国研发CTLA-4单抗。此次申请的基础是基于在中国开展的随机、对照、多中心、III期注册研究(NeoShot,NCT05890742)的结果。","market":"hk","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://finance.eastmoney.com/a/202502243327128374.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_eastmoney","symbols":["LU2328871848.SGD","BK1589","01801","BK1583","LU1969619763.USD","LU2488822045.USD","BK1161"],"gpt_icon":0},{"id":"2513662762","title":"信达生物(01801.HK)伊匹木单抗注射液新药上市申请获内地受理并纳入优先审评程序","url":"https://stock-news.laohu8.com/highlight/detail?id=2513662762","media":"阿斯达克财经","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513662762?lang=zh_cn&edition=fundamental","pubTime":"2025-02-24 08:30","pubTimestamp":1740357000,"startTime":"0","endTime":"0","summary":"信达生物(01801.HK) 公布,伊匹木单抗注射液(抗细胞毒T淋巴细胞相关抗原4 (CTLA-4)单抗,研发代号:IBI310)联合信迪利单抗用于可切除的微卫星高度不稳定型(MSI-H)或错配修复缺陷型(dMMR)结肠癌患者的新辅助治疗的新药上市申请(NDA),已获中国国家药监局药品审评中心受理并纳入优先审评程序。伊匹木单抗是首个递交NDA的中国研发的CTLA-4单抗,同时也是信迪利单抗奠定其肿瘤免疫治疗领先品牌的又一里程碑。(jl/w)(港股报价延迟最少十五分钟。沽空资料截至 2025-02-21 16:25。)AASTOCKS新闻","market":"fut","thumbnail":"https://plib.aastocks.com/aafnnews/image/medialib/20190319114710011_s.jpg","type":0,"news_type":0,"thumbnails":["https://plib.aastocks.com/aafnnews/image/medialib/20190319114710011_s.jpg"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"http://www.aastocks.com/tc/stocks/analysis/china-hot-topic-content.aspx?id=NOW.1419464&catg=4&source=AAFN","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":"aastocks_highlight","symbols":["01801","BK1589","LU1969619763.USD","BK1161","LU2328871848.SGD","LU2488822045.USD","BK1583"],"gpt_icon":0},{"id":"2513769736","title":"信达生物PD-1联合疗法申报上市获受理;艾美疫苗全面接入DeepSeek大模型","url":"https://stock-news.laohu8.com/highlight/detail?id=2513769736","media":"每日经济新闻","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513769736?lang=zh_cn&edition=fundamental","pubTime":"2025-02-24 07:53","pubTimestamp":1740354796,"startTime":"0","endTime":"0","summary":"丨 2025年2月24日星期一丨NO.1信达生物PD-1联合疗法申报上市获受理2月22日,CDE官网公示,信达生物“信迪利单抗注射液”和“伊匹木单抗注射液”的联合疗法上市申请获得受理。其中,信迪利单抗是一种PD-1抑制剂,已在国内获批8项适应证。","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250224075515a2512280&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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07:52","pubTimestamp":1740354720,"startTime":"0","endTime":"0","summary":"伊匹木单抗是首个递交NDA的中国研发的CTLA-4单抗,同时,这也是信迪利单抗奠定其肿瘤免疫治疗领先品牌的又一里程碑。研究旨在评估伊匹木单抗联合信迪利单抗新辅助治疗可切除的MSI-H/dMMR结肠癌对比直接根治性手术的有效性和安全性。伊匹木单抗联合信迪利单抗组与信迪利单抗单药组术后病理淋巴结阳性率分别为3.9%与15.9%。伊匹木单抗联合信迪利单抗用于可切除的MSI-H/dMMR结肠癌患者的新辅助治疗的NDA在NMPA优先审评中。","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":"https://wwwold.prnasia.com/story/archive/4625139_ZH25139_1","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":"prnasia","symbols":["01801","BK4585","BK4500","BK1589","CDE","BK4017","BK4588","BK4139","LU2488822045.USD","PP","BK1583","IVBIY","BK4008","LU2328871848.SGD","LU1969619763.USD","BK1161","ALK"],"gpt_icon":0},{"id":"2513227769","title":"信达生物:伊匹木单抗注射液联合信迪利单抗用于结肠癌新辅助治疗的新药上市申请获国家药品监督管理局受理并纳入优先审评","url":"https://stock-news.laohu8.com/highlight/detail?id=2513227769","media":"每日经济新闻","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513227769?lang=zh_cn&edition=fundamental","pubTime":"2025-02-24 07:45","pubTimestamp":1740354305,"startTime":"0","endTime":"0","summary":"每经AI快讯,2月24日,信达生物在港交所公告,伊匹木单抗注射液联合信迪利单抗用于结肠癌新辅助治疗的新药上市申请获国家药品监督管理局受理并纳入优先审评。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"stock_eastmoney","url":"http://finance.eastmoney.com/a/202502243326968640.html","rn_cache_url":null,"directOrigin":true},"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"http://finance.eastmoney.com/a/202502243326968640.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_eastmoney","symbols":["01801","LU2328871848.SGD","LU1969619763.USD","BK1161","BK1589","LU2488822045.USD","BK1583"],"gpt_icon":0},{"id":"2513695217","title":"【信达生物(01801.HK):伊匹木单抗注射液联合信迪利单抗用于结肠癌新辅助治疗的新药上市申请获国家药品监督管理局受理并纳入优先审评】信达生物(01801.HK)公布,伊匹木单抗注射液(抗细胞毒T淋巴细胞相关抗原4(CTLA-4单抗,研发代号:IBI310)联合信迪利单抗用于可切除的微卫星高度不稳定型(MSI-H)或错配修复缺陷型(dMMR)结肠癌患者的新辅助治疗的新药上市申请(NDA)已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)受理并纳入优先审评程序。伊匹木单抗是首个递交NDA的中国研发的CTLA-4单抗,同时,这也是信迪利单抗奠定其肿瘤免疫治疗领先品牌的又一里程碑。","url":"https://stock-news.laohu8.com/highlight/detail?id=2513695217","media":"金融界","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513695217?lang=zh_cn&edition=fundamental","pubTime":"2025-02-24 07:37","pubTimestamp":1740353863,"startTime":"0","endTime":"0","summary":"信达生物(01801.HK)公布,伊匹木单抗注射液(抗细胞毒T淋巴细胞相关抗原4(CTLA-4单抗,研发代号:IBI310)联合信迪利单抗用于可切除的微卫星高度不稳定型(MSI-H)或错配修复缺陷型(dMMR)结肠癌患者的新辅助治疗的新药上市申请(NDA)已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)受理并纳入优先审评程序。伊匹木单抗是首个递交NDA的中国研发的CTLA-4单抗,同时,这也是信迪利单抗奠定其肿瘤免疫治疗领先品牌的又一里程碑。","market":"us","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/2025/02/24073748332964.shtml","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"jinrongjie_stock","symbols":["LU2065171402.SGD","LU0354030511.USD","LU2322448791.USD","BK4017","LU2125909916.SGD","LU2506952170.USD","LU2272731600.USD","LU2473716301.USD","LU2065171311.SGD","LU0354030438.USD","LU2488822045.USD","LU2125909759.SGD","LU1974910355.USD","CDE","LU1992135399.USD","IE00B775SV38.USD","LU2506951875.HKD","LU2506951958.HKD","01801","LU2065170008.USD","LU2272731865.HKD","BK4020","BK4585","LU2322448957.HKD","IE0034235188.USD","LU2023250843.SGD","LU1923622291.USD","LU1969619763.USD","LU1917777945.USD","MSI","LU0823417653.USD","BK4588","BK1589","LU2065169927.USD","LU0823417737.USD","IE00B3S45H60.SGD","LU2272731782.SGD","LU2023250504.SGD","LU0950375773.USD","BK1161","LU1992135472.HKD","LU2106854487.HKD","LU2328871848.SGD","BK1583","LU2506952097.USD","LU2247934214.USD"],"gpt_icon":0},{"id":"2513766014","title":"信达生物(01801):伊匹木单抗注射液联合信迪利单抗用于结肠癌新辅助治疗的新药上市申请获国家药品监督管理局受理并纳入优先审评","url":"https://stock-news.laohu8.com/highlight/detail?id=2513766014","media":"智通财经","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513766014?lang=zh_cn&edition=fundamental","pubTime":"2025-02-24 07:33","pubTimestamp":1740353607,"startTime":"0","endTime":"0","summary":"智通财经APP讯,信达生物 公布,伊匹木单抗注射液(抗细胞毒T淋巴细胞相关抗原4(CTLA-4单抗,研发代号:IBI310)联合信迪利单抗用于可切除的微卫星高度不稳定型(MSI-H)或错配修复缺陷型(dMMR)结肠癌患者的新辅助治疗的新药上市申请(NDA)已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)受理并纳入优先审评程序。研究旨在评估伊匹木单抗联合信迪利单抗新辅助治疗可切除的MSI-H/dMMR结肠癌对比直接根治性手术的有效性和安全性。","market":"hk","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/1253170.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":"信达生物(01801):伊匹木单抗注射液联合信迪利单抗用于结肠癌新辅助治疗的新药上市申请获国家药品监督管理局受理并纳入优先审评","news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"stock_zhitongcaijing","symbols":["LU2488822045.USD","LU1969619763.USD","BK1589","01801","LU2328871848.SGD","BK1583","BK1161"],"gpt_icon":0},{"id":"2513279971","title":"信达生物信迪利单抗癌症联合疗法申报上市,科济药业CAR-T细胞疗法拟纳入突破性治疗品种","url":"https://stock-news.laohu8.com/highlight/detail?id=2513279971","media":"医药经济报","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513279971?lang=zh_cn&edition=fundamental","pubTime":"2025-02-22 20:05","pubTimestamp":1740225953,"startTime":"0","endTime":"0","summary":"信达生物信迪利单抗癌症联合疗法申报上市今日,中国国家药监局药品审评中心官网最新公示,信达生物申报的伊匹木单抗注射液和信迪利单抗注射液的上市申请获得受理。公开资料显示,这是信达生物在研的抗CTLA-4单抗IBI310与抗PD-1单抗信迪利单抗联合疗法。公开资料显示,这是科济药业在研的靶向Claudin18.2蛋白的自体CAR-T细胞候选产品舒瑞基奥仑赛注射液,该产品已经在针对G/GEJ腺癌的中国关键2期临床试验中取得阳性结果。","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250222201032abd89de3&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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18:03","pubTimestamp":1740132221,"startTime":"0","endTime":"0","summary":"2020年,公司迎来第二个关键之年,同期三款药品获批上市。其中,第四季度超20亿元,同比增长超25%。若保持此增速,200亿元产品收入的目标并非遥不可及。下一把,信达生物和俞德超的重点选择或放在抗PCSK9单抗、玛仕度肽。个人是与非带领信达生物向前之际,俞德超的个人财富也在膨胀。收购方Lostrancos由俞德超直接管理并担任唯一董事。巧合的是,公告前俞德超减持信达生物的部分股份,总金额约1.52亿港元。2023年,公司前质量部门员工爆料内部裁员。","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250221181218abd768b9&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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