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CHMP 冠军工业
休市中 10-02 16:00:00 EDT 延时
资讯
新帖
简况
英派药业-B(07630)盘中拉升逾40% 药品Sepalna上市许可获欧洲CHMP建议批准
金吾财讯 · 09-21
英派药业-B(07630)盘中拉升逾40% 药品Sepalna上市许可获欧洲CHMP建议批准
贝达药业:盐酸恩沙替尼胶囊获欧洲CHMP积极意见
智通财经 · 09-20
贝达药业:盐酸恩沙替尼胶囊获欧洲CHMP积极意见
阿斯利康(AZN)与第一三共联合研发ADC药物Enhertu®获欧盟CHMP推荐批准
金吾财讯 · 09-18
阿斯利康(AZN)与第一三共联合研发ADC药物Enhertu®获欧盟CHMP推荐批准
罗氏(RHHBY)重磅药Ocrevus获CHMP积极意见 拟在欧洲拓展儿科多发性硬化症适应症
金吾财讯 · 09-18
罗氏(RHHBY)重磅药Ocrevus获CHMP积极意见 拟在欧洲拓展儿科多发性硬化症适应症
诺和诺德每周一次用药Sogroya®在欧洲获得CHMP积极意见,用于治疗儿童特发性矮小症。
智通财经 · 09-18
诺和诺德每周一次用药Sogroya®在欧洲获得CHMP积极意见,用于治疗儿童特发性矮小症。
欧洲药品管理局:赛诺菲温莎工业因与CHMP意见分歧撤回Dupixent申请。
智通财经 · 08-18
欧洲药品管理局:赛诺菲温莎工业因与CHMP意见分歧撤回Dupixent申请。
罗氏(RHHBY)眼科创新药Susvimo获欧盟CHMP积极推荐
金吾财讯 · 07-24
罗氏(RHHBY)眼科创新药Susvimo获欧盟CHMP积极推荐
吉利德科学(GILD)肿瘤组合疗法获欧洲药品管理局旗下CHMP推荐
金吾财讯 · 07-24
吉利德科学(GILD)肿瘤组合疗法获欧洲药品管理局旗下CHMP推荐
阿斯利康(AZN)与第一三共重磅新药获欧盟CHMP推荐批准 拟用于三阴性乳腺癌成年患者治疗
金吾财讯 · 06-26
阿斯利康(AZN)与第一三共重磅新药获欧盟CHMP推荐批准 拟用于三阴性乳腺癌成年患者治疗
EMA旗下CHMP建议允许非医疗专业人员监督下使用Fluenz鼻喷疫苗
美股速递 · 06-26
EMA旗下CHMP建议允许非医疗专业人员监督下使用Fluenz鼻喷疫苗
美股前瞻 | 三大股指期货齐跌,特朗普“TRUMP币“吸金亿元但散户血亏,本周聚焦1月非农
智通财经网 · 2025-02-03
美股前瞻 | 三大股指期货齐跌,特朗普“TRUMP币“吸金亿元但散户血亏,本周聚焦1月非农
一哥的业绩,投资人不买账
并购菁英汇 · 2024-11-18
一哥的业绩,投资人不买账
摸不准的AD市场
佰傲谷BioValley · 2024-11-12
摸不准的AD市场
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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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药品Sepalna上市许可获欧洲CHMP建议批准","url":"https://stock-news.laohu8.com/highlight/detail?id=2669349171","media":"金吾财讯","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/2669349171?lang=zh_cn&edition=full","pubTime":"2026-09-21 11:33","pubTimestamp":1789961630,"startTime":"0","endTime":"0","summary":"金吾财讯 | 英派药业-B 盘中逆市拉升40.06%,暂报18.25港元,成交额3.25亿港元。消息面上,该公司发布公告,欧洲药品管理局人用药品委员会已通过了一项积极意见,建议批准药品Sepalna的上市许可,该药旨在用于晚期上皮性卵巢癌、输卵管癌及原发性腹膜癌的维持治疗。于CHMP建议批准后,塞纳帕利将提交至欧盟委员会作出最终决定。一旦获得欧盟委员会批准,塞纳帕利将获准在所有欧盟成员国及欧洲经济区国家上市销售。","market":"hk","thumbnail":"https://static.szfiu.com/news/20241108/YjA5ZTU5M2U3ZjIyNGI4Mzk2MWM1NGUyNWZkZjFmMjE3MzEwNTIzMzcxNTY=.jpg","type":0,"news_type":0,"thumbnails":["https://static.szfiu.com/news/20241108/YjA5ZTU5M2U3ZjIyNGI4Mzk2MWM1NGUyNWZkZjFmMjE3MzEwNTIzMzcxNTY=.jpg"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"1992064","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4087","CHMP","07630","IPOS","BK1161"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2668837191","title":"贝达药业:盐酸恩沙替尼胶囊获欧洲CHMP积极意见","url":"https://stock-news.laohu8.com/highlight/detail?id=2668837191","media":"智通财经","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/2668837191?lang=zh_cn&edition=full","pubTime":"2026-09-20 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人用药品委员会出具积极意见,推荐批准由第一三共与阿斯利康联合开发的ADC药物Enhertu,用于新辅助治疗后仍有残留浸润性病灶的高危HER2阳性早期乳腺癌成年患者的辅助治疗。结果显示,与现有标准疗法T-DM1相比,Enhertu将患者的浸润性疾病复发或死亡风险大幅降低了53%,三年无浸润性疾病生存率达到92.4%。目前该意见已提交欧盟委员会进行最终上市许可审批,若顺利获批,Enhertu有望重塑欧洲早期乳腺癌术后治疗标准。","market":"other","thumbnail":"https://static.szfiu.com/news/20250107/NTkwMTRiMmRhYjljZTk4MGRjMGViZTQ1NDI1NzQxMTc4OQ==.png","type":0,"news_type":0,"thumbnails":["https://static.szfiu.com/news/20250107/NTkwMTRiMmRhYjljZTk4MGRjMGViZTQ1NDI1NzQxMTc4OQ==.png"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"306231","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":null,"symbols":["AZNH","LU0889565916.HKD","BK4568","LU2468319806.SGD","LU2236285917.USD","LU0029864427.USD","LU2456880835.USD","LU2089984988.USD","AZN","LU1829250122.USD","LU2237443978.SGD","BK4588","LU2237443382.USD","LU0320765992.SGD","LU2237443622.USD","BK4585","LU0432979614.USD","LU2237443549.SGD","LU0109394709.USD","LU0128525929.USD","LU0708994859.HKD","LU2237443465.HKD","FESXmain","LU0310800379.SGD","BK4007","LU0058720904.USD","BK4087","LU0289739699.SGD","LU2237443895.HKD","LU1267930573.SGD","FSXEmain","IE00B3T34201.USD","CHMP","LU2462157665.USD","LU2417539215.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2668492808","title":"罗氏(RHHBY)重磅药Ocrevus获CHMP积极意见 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获得欧洲药品管理局人用药品委员会积极审查意见,建议批准其旗下的抗CD20单克隆抗体药物Ocrevus,用于治疗10岁及以上儿童和青少年的复发型多发性硬化症。据介绍,继美国FDA于2026年5月批准该适应症后,若欧盟顺利获批,Ocrevus将成为欧洲首个面向10岁及以上儿科患者的高效抗CD20疗法,进一步巩固罗氏在神经科学及多发性硬化症治疗领域的市场领先地位。","market":"hk","thumbnail":"https://static.szfiu.com/news/20250107/MWRmODAzMDJiNzRkNTY3ODIxNTExMzM=.png","type":0,"news_type":0,"thumbnails":["https://static.szfiu.com/news/20250107/MWRmODAzMDJiNzRkNTY3ODIxNTExMzM=.png"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"306226","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":null,"symbols":["BK4087","CANC","03165","RHHBY","HRTS","BK4007","CHMP"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2668947286","title":"诺和诺德每周一次用药Sogroya®在欧洲获得CHMP积极意见,用于治疗儿童特发性矮小症。","url":"https://stock-news.laohu8.com/highlight/detail?id=2668947286","media":"智通财经","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/2668947286?lang=zh_cn&edition=full","pubTime":"2026-09-18 18:36","pubTimestamp":1789727806,"startTime":"0","endTime":"0","summary":null,"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://www.zhitongcaijing.com/immediately.html?type=usstock","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":"live_zhitongcaijing","symbols":["BGIA","BK4087","CHMP"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2660735461","title":"欧洲药品管理局:赛诺菲温莎工业因与CHMP意见分歧撤回Dupixent申请。","url":"https://stock-news.laohu8.com/highlight/detail?id=2660735461","media":"智通财经","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/2660735461?lang=zh_cn&edition=full","pubTime":"2026-08-18 19:15","pubTimestamp":1787051726,"startTime":"0","endTime":"0","summary":null,"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://www.zhitongcaijing.com/immediately.html?type=usstock","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":"live_zhitongcaijing","symbols":["BK4087","CHMP"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2653089692","title":"罗氏(RHHBY)眼科创新药Susvimo获欧盟CHMP积极推荐","url":"https://stock-news.laohu8.com/highlight/detail?id=2653089692","media":"金吾财讯","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/2653089692?lang=zh_cn&edition=full","pubTime":"2026-07-24 18:46","pubTimestamp":1784890007,"startTime":"0","endTime":"0","summary":"此外,传统月度频繁注射给患者带来巨大就医负担,Susvimo 长效方案大幅降低就诊频次,具备显著临床与商业化价值。罗氏首席医学官表示,CHMP 的积极推荐将为欧洲患者带来全新低负担治疗选择。","market":"us","thumbnail":"https://static.szfiu.com/news/20210810/NTNlMDYzZTc4ZWFmNGZiMGI1NGE4MDhhNDkyYzIxNWQxMTI3MjMzNjI1NzE=.jpg","type":0,"news_type":0,"thumbnails":["https://static.szfiu.com/news/20210810/NTNlMDYzZTc4ZWFmNGZiMGI1NGE4MDhhNDkyYzIxNWQxMTI3MjMzNjI1NzE=.jpg"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"302999","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":null,"symbols":["MEDX","HRTS","06978","BK4007","RHHBY","FESXmain","FSXEmain","03165","BK1574","BK4087","CHMP","LNGR","159992","BK1161","CANC","IBBQ"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2653895100","title":"吉利德科学(GILD)肿瘤组合疗法获欧洲药品管理局旗下CHMP推荐","url":"https://stock-news.laohu8.com/highlight/detail?id=2653895100","media":"金吾财讯","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/2653895100?lang=zh_cn&edition=full","pubTime":"2026-07-24 18:45","pubTimestamp":1784889935,"startTime":"0","endTime":"0","summary":"金吾财讯 | 吉利德科学 宣布,欧洲药品管理局旗下人用药品委员会已发布积极意见,建议批准其Trop-2靶向ADC药物Trodelvy联合帕博利珠单抗,用于既往未接受过全身治疗、且肿瘤PD-L1表达阳性的不可切除局部晚期或转移性三阴性乳腺癌成人患者。若欧盟委员会于2026年晚些时候正式批准该联合疗法,Trodelvy将实现从单药到联合疗法、全面覆盖不同PD-L1表达状态的mTNBC一线治疗布局。","market":"fut","thumbnail":"https://static.szfiu.com/news/20210810/NmQ4YmNlMWEyMTYyODU5MDQwMjQzMA==.jpg","type":0,"news_type":0,"thumbnails":["https://static.szfiu.com/news/20210810/NmQ4YmNlMWEyMTYyODU5MDQwMjQzMA==.jpg"],"rights":null,"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"302998","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU0320765992.SGD","LU2468319806.SGD","SG9999015986.USD","LU1571399168.USD","BK4585","LU0234570918.USD","BK4578","GILD","LU1023059063.AUD","LU1585245621.USD","SG9999015945.SGD","SG9999015952.SGD","IBB","LU1057294990.SGD","IE00B19Z3581.USD","CHMP","MEDI","BIB","BK4583","IBBQ","SG9999015978.USD","BK4550","LU1934455194.USD","LU0889565916.HKD","BBH","BK4568","LU0965509101.SGD","LU1934455863.HKD","LU0122379950.USD","LU2324357040.USD","TBXU","LU1674673428.USD","LU0058720904.USD","LU1037948541.HKD","TMED","LU2089984988.USD","BMED","LU0965509010.AUD","IE00BSNM7G36.USD","IE0002270589.USD","BK4139","LU1066051498.USD","IE00BZ1G4Q59.USD","LU1061106388.HKD","BK4588","LU2087621335.USD","LU0965508806.USD","LU0823416689.USD","IE00B3T34201.USD","LU0289739699.SGD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2646354848","title":"阿斯利康(AZN)与第一三共重磅新药获欧盟CHMP推荐批准 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