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CHMP 冠军工业
盘后交易 05-20 16:00:00 EDT 延时
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和黄医药(00013.HK)合作伙伴武田创新药呋喹替尼获CHMP积极意见
阿斯达克财经 · 04-28
和黄医药(00013.HK)合作伙伴武田创新药呋喹替尼获CHMP积极意见
呋喹替尼获欧洲药品管理局CHMP积极意见用于结直肠癌
美通社 · 04-26
呋喹替尼获欧洲药品管理局CHMP积极意见用于结直肠癌
基石药业公布2023年年度业绩及公司近期业务进展
美通社 · 03-27
基石药业公布2023年年度业绩及公司近期业务进展
亿帆医药(002019.SZ)控股子公司在研产品获欧盟委员会批准上市
智通财经 · 03-24
亿帆医药(002019.SZ)控股子公司在研产品获欧盟委员会批准上市
欧洲监管机构建议批准一周一次胰岛素用于治疗糖尿病
金吾财讯 · 03-22
欧洲监管机构建议批准一周一次胰岛素用于治疗糖尿病
11:0全票通过 FDA肿瘤药物咨询委员会推荐CARVYKTI®用于早期治疗
美通社 · 03-16
11:0全票通过 FDA肿瘤药物咨询委员会推荐CARVYKTI®用于早期治疗
百济神州(06160.HK)替雷利珠单抗获CHMP积极意见
阿斯达克财经 · 02-27
百济神州(06160.HK)替雷利珠单抗获CHMP积极意见
港股异动 | 金斯瑞生物科技(01548)高开逾4% 传奇生物CARVYKTI获CHMP积极意见
智通财经 · 02-26
港股异动 | 金斯瑞生物科技(01548)高开逾4% 传奇生物CARVYKTI获CHMP积极意见
金斯瑞(01548.HK)附属传奇生物CARVYKTI获CHMP积极意见
阿斯达克财经 · 02-25
金斯瑞(01548.HK)附属传奇生物CARVYKTI获CHMP积极意见
传奇生物获得CHMP对CARVYKTI®用于前线治疗的积极意见
美通社 · 02-23
传奇生物获得CHMP对CARVYKTI®用于前线治疗的积极意见
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公司概况
公司名称:
冠军工业
所属市场:
EXPERT
上市日期:
--
主营业务:
2450 First Avenue P.O. Box 2968 Huntington West Virginia
发行价格:
--
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22:54","pubTimestamp":1714316040,"startTime":"0","endTime":"0","summary":"和黄医药公布,合作伙伴武田取得欧洲药品管理局“EMA”人用药品委员会“CHMP”建议批准呋喹替尼用于治疗经治的成人转移性结直肠癌患者。欧盟委员会 在决定呋喹替尼用于治疗转移性结直肠癌在整个欧盟、挪威、列支敦士登和冰岛的上市许可时,将会把CHMP的积极意见纳入考量。倘获批,呋喹替尼将成为欧盟批准用于经治转移性结直肠癌的第一个也是唯一一个所有三种血管内皮生长因子受体“VEGFR”的选择性抑制剂。","market":"fut","thumbnail":"http://plib.aastocks.com/aafnnews/image/medialib/20191009132908649_s.jpg","type":0,"news_type":0,"thumbnails":["http://plib.aastocks.com/aafnnews/image/medialib/20191009132908649_s.jpg"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"http://www.aastocks.com/tc/stocks/news/aafn-con/NOW.1345625/latest-news/AAFN","is_publish_highlight":false,"gpt_icon":0},{"id":"2430232208","title":"呋喹替尼获欧洲药品管理局CHMP积极意见用于结直肠癌","url":"https://stock-news.laohu8.com/highlight/detail?id=2430232208","media":"美通社","top":-1,"share":"https://www.laohu8.com/m/news/2430232208?lang=zh_cn&edition=full","pubTime":"2024-04-26 21:39","pubTimestamp":1714138740,"startTime":"0","endTime":"0","summary":"欧盟委员会在决定呋喹替尼用于治疗转移性结直肠癌在整个欧盟、挪威、列支敦士登和冰岛的上市许可时,将会把CHMP的积极意见纳入考虑。如果获得批准,呋喹替尼将成为欧盟批准用于经治转移性结直肠癌的第一个也是唯一一个所有三种血管内皮生长因子受体的选择性抑制剂。目前,欧盟转移性结直肠癌患者可用的治疗选择有限,导致治疗结果不佳。自呋喹替尼在中国上市以来,截至2023年年中已有超过8万名结直肠癌患者接受呋喹替尼治疗。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"https://wwwold.prnasia.com/story/archive/4398604_ZH98604_1","is_publish_highlight":false,"gpt_icon":0},{"id":"2422133959","title":"基石药业公布2023年年度业绩及公司近期业务进展","url":"https://stock-news.laohu8.com/highlight/detail?id=2422133959","media":"美通社","top":-1,"share":"https://www.laohu8.com/m/news/2422133959?lang=zh_cn&edition=full","pubTime":"2024-03-27 22:00","pubTimestamp":1711548000,"startTime":"0","endTime":"0","summary":"2023年总收入为人民币4.638亿元,其中商业化收入人民币3.681亿元。稳健的财务状况,截至2023年12月31日现金储备为10.3亿人民币;年内亏损减少57%。预期两项申请将在2024年陆续获批。苏州2024年3月27日 /美通社/ -- 基石药业,一家专注于研究开发及商业化创新肿瘤免疫疗法及精准治疗药物的领先生物制药公司,今日公布其2023年年度业绩及近期业务亮点。业务摘要 截至2023年12月31日止年度及截至本公告日期,我们的产品管线及业务经营均已取得重大进展。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"https://wwwold.prnasia.com/story/archive/4372459_ZH72459_1","is_publish_highlight":false,"gpt_icon":0},{"id":"2421734727","title":"亿帆医药(002019.SZ)控股子公司在研产品获欧盟委员会批准上市","url":"https://stock-news.laohu8.com/highlight/detail?id=2421734727","media":"智通财经","top":-1,"share":"https://www.laohu8.com/m/news/2421734727?lang=zh_cn&edition=full","pubTime":"2024-03-24 16:30","pubTimestamp":1711269025,"startTime":"0","endTime":"0","summary":"智通财经APP讯,亿帆医药 发布公告,该公司控股子公司 Evive Biotechnology Ireland Limited于北京时间2024年3月22日收到欧盟委员会签发的《委员会执行决议,COMMISSION IMPLEMENTING DECISION》,批准公司在研产品艾贝格司亭α注射液在欧盟上市销售,该决定基于欧洲药品管理局人用药品委员会的积极审查意见。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"http://www.zhitongcaijing.com/content/detail/1091103.html","is_publish_highlight":false,"gpt_icon":0},{"id":"2421586000","title":"欧洲监管机构建议批准一周一次胰岛素用于治疗糖尿病","url":"https://stock-news.laohu8.com/highlight/detail?id=2421586000","media":"金吾财讯","top":-1,"share":"https://www.laohu8.com/m/news/2421586000?lang=zh_cn&edition=full","pubTime":"2024-03-22 18:15","pubTimestamp":1711102515,"startTime":"0","endTime":"0","summary":"金吾财讯 | 诺和诺德宣布,欧洲药品管理局人用药品委员会(CHMP)采纳了积极意见,建议给予Awiqli®(基础胰岛素周制剂依柯(icodec)胰岛素)用于治疗成人糖尿病的上市许可。Awiqli®是每周一次的基础胰岛素类似物,被设计为一次皮下注射即可满足整整一周的基础胰岛素需求。","market":"nz","thumbnail":"https://static.szfiu.com/news/20210625/YzM0ZmE0OGYyYmI1ZTk0YjVmZmU4ZTU4MTIzMDA2MDU4MDg=.jpg","type":0,"news_type":0,"thumbnails":["https://static.szfiu.com/news/20210625/YzM0ZmE0OGYyYmI1ZTk0YjVmZmU4ZTU4MTIzMDA2MDU4MDg=.jpg"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"274255","is_publish_highlight":false,"gpt_icon":0},{"id":"2419501781","title":"11:0全票通过 FDA肿瘤药物咨询委员会推荐CARVYKTI®用于早期治疗","url":"https://stock-news.laohu8.com/highlight/detail?id=2419501781","media":"美通社","top":-1,"share":"https://www.laohu8.com/m/news/2419501781?lang=zh_cn&edition=full","pubTime":"2024-03-16 12:00","pubTimestamp":1710561600,"startTime":"0","endTime":"0","summary":"肿瘤药物咨询委员会应美国 FDA 要求组建,负责审查和评估用于治疗肿瘤疾病的人用药物产品的安全性和有效性数据。该委员会根据其评估结果提供非约束性建议;由FDA作出最终药物是否批准的决定。2022年2月,西达基奥仑赛获得美国FDA批准上市,5月获得欧盟EC授予的附条件上市许可,9月获得日本MHLW批准上市,用于治疗复发或难治性多发性骨髓瘤成人患者,商品名为CARVYKTI。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"https://wwwold.prnasia.com/story/archive/4362975_ZH62975_1","is_publish_highlight":false,"gpt_icon":0},{"id":"2414834759","title":"百济神州(06160.HK)替雷利珠单抗获CHMP积极意见","url":"https://stock-news.laohu8.com/highlight/detail?id=2414834759","media":"阿斯达克财经","top":-1,"share":"https://www.laohu8.com/m/news/2414834759?lang=zh_cn&edition=full","pubTime":"2024-02-27 00:29","pubTimestamp":1708964940,"startTime":"0","endTime":"0","summary":"百济神州(06160.HK) 公布,欧洲药品管理局(EMA)人用药品委员会(CHMP)推荐替雷利珠单抗获得上市许可的积极意见,建议批准用于治疗三项非小细胞肺癌(NSCLC)适应症。替雷利珠单抗(英文商品名:TEVIMBRA)是一款人源化IgG4抗PD-1单克隆抗体,对PD-1具有高亲和力和结合特异性,帮助人体免疫细胞识别并杀伤肿瘤细胞。(de/d)(港股报价延迟最少十五分钟。沽空资料截至 2024-02-26 16:25。)AASTOCKS新闻","market":"us","thumbnail":"http://plib.aastocks.com/aafnnews/image/medialib/20210201153351459_s.jpg","type":0,"news_type":0,"thumbnails":["http://plib.aastocks.com/aafnnews/image/medialib/20210201153351459_s.jpg"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"http://www.aastocks.com/tc/stocks/news/aafn-con/NOW.1328840/latest-news/AAFN","is_publish_highlight":false,"gpt_icon":0},{"id":"2414046578","title":"港股异动 | 金斯瑞生物科技(01548)高开逾4% 传奇生物CARVYKTI获CHMP积极意见","url":"https://stock-news.laohu8.com/highlight/detail?id=2414046578","media":"智通财经","top":-1,"share":"https://www.laohu8.com/m/news/2414046578?lang=zh_cn&edition=full","pubTime":"2024-02-26 09:23","pubTimestamp":1708910617,"startTime":"0","endTime":"0","summary":"智通财经APP获悉,金斯瑞生物科技(01548)早盘高开逾4%,截至发稿,涨4.03%,报15.5港元,成交额598.3万港元。消息面上,金斯瑞生物科技公布,附属传奇生物获得欧洲药品管理局(EMA)人用药品委员会(CHMP)建议批准扩大CARVYKTI(cilta-cel,西达基奥仑赛)的标签范围,以纳入既往至少接受过一种治疗的复发和难治性多发性骨髓瘤成人患者。据悉,此项II类变更申请由与传奇生物开发和商业化CARVYKTI的合作方Janssen-Cilag提交至EMA,CHMP的积极意见将由欧盟委员会进行审查并做出最终批准决定。","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"http://www.zhitongcaijing.com/content/detail/1076484.html","is_publish_highlight":false,"gpt_icon":0},{"id":"2414906193","title":"金斯瑞(01548.HK)附属传奇生物CARVYKTI获CHMP积极意见","url":"https://stock-news.laohu8.com/highlight/detail?id=2414906193","media":"阿斯达克财经","top":-1,"share":"https://www.laohu8.com/m/news/2414906193?lang=zh_cn&edition=full","pubTime":"2024-02-25 19:44","pubTimestamp":1708861440,"startTime":"0","endTime":"0","summary":"金斯瑞生物科技(01548.HK) 公布,附属传奇生物获得欧洲药品管理局(EMA)人用药品委员会(CHMP)建议批准扩大CARVYKTI(cilta-cel,西达基奥仑赛)的标签范围,以纳入既往至少接受过一种治疗的复发和难治性多发性骨髓瘤成人患者。此项 II 类变更申请由与传奇生物开发和商业化 CARVYKTI的合作方Janssen-Cilag提交至 EMA,CHMP 的积极意见将由欧盟委员会进行审查并做出最终批准决定。(de/d)(港股报价延迟最少十五分钟。沽空资料截至 2024-02-23 16:25。)AASTOCKS新闻","market":"sh","thumbnail":"http://plib.aastocks.com/aafnnews/image/medialib/20191009132908649_s.jpg","type":0,"news_type":0,"thumbnails":["http://plib.aastocks.com/aafnnews/image/medialib/20191009132908649_s.jpg"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"http://www.aastocks.com/tc/stocks/news/aafn-con/NOW.1328539/latest-news/AAFN","is_publish_highlight":false,"gpt_icon":0},{"id":"2413593763","title":"传奇生物获得CHMP对CARVYKTI®用于前线治疗的积极意见","url":"https://stock-news.laohu8.com/highlight/detail?id=2413593763","media":"美通社","top":-1,"share":"https://www.laohu8.com/m/news/2413593763?lang=zh_cn&edition=full","pubTime":"2024-02-23 20:47","pubTimestamp":1708692420,"startTime":"0","endTime":"0","summary":"传奇生物首席执行官黄颖博士表示:\"这一里程碑表明了我们将CARVYKTI带给全球更多及更前线患者以改变治疗格局的承诺。CHMP 的积极意见是将CARVYKTI用于欧洲更多患者以使其得益于该一次性输注疗法的重要一步。2022年2月,西达基奥仑赛获得美国FDA批准上市,5月获得欧盟EC授予的附条件上市许可,9月获得日本MHLW批准上市,用于治疗复发或难治性多发性骨髓瘤成人患者,商品名为CARVYKTI。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"isJumpTheme":false,"source_url":"https://wwwold.prnasia.com/story/archive/4344094_ZH44094_1","is_publish_highlight":false,"gpt_icon":0}],"profile":{"websiteUrl":"http://www.champion-industries.com","stockEarnings":[{"period":"1week","weight":-0.0313},{"period":"1month","weight":-0.0306},{"period":"3month","weight":0.1071},{"period":"6month","weight":0.1071},{"period":"1year","weight":0.069},{"period":"ytd","weight":-0.225}],"description":"2450 First Avenue P.O. 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