万达生物制药(VNDA)_个股概要_股票价格_最新资讯_行情走势_历史数据 - 老虎社区

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VNDA 万达生物制药

盘前交易 08-25 04:51:57 EDT

5.33

+0.05

+0.95%

盘前5.15

-0.18-3.38%

04:43 EDT

最高5.37	最低5.20	成交量77.43万
今开5.34	昨收5.28	日振幅3.22%
总市值3.22亿	流通市值2.54亿	总股本6,046万
成交额411.04万	换手率1.62%	流通股本4,766万
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Pharmaceuticals）旗下在研药物Imsidolimab用于治疗泛发性脓疱型银屑病的孤儿药资格认定。这一决定标志着该药物在罕见皮肤病领域获得了监管层面的重要认可，有望加速其后续的临床开发与上市审批进程。","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":"","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":["VNDA","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1111995389","title":"万达生物制药宣布Imsidolimab治疗GPP获欧洲药品管理局孤儿药资格积极意见","url":"https://stock-news.laohu8.com/highlight/detail?id=1111995389","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1111995389?lang=zh_cn&edition=full","pubTime":"2026-07-17 04:31","pubTimestamp":1784233875,"startTime":"0","endTime":"0","summary":"万达生物制药宣布，其候选药物Imsidolimab用于治疗泛发性脓疱型银屑病（GPP）的孤儿药资格申请，已获得欧洲药品管理局（EMA）人用药品委员会（CHMP）的积极意见。\n孤儿药资格旨在鼓励针对罕见疾病的药物开发。获得EMA的积极意见是Imsidolimab在欧洲监管路径上的一个重要进展，为其后续的上市申请奠定了基础。这一进展有望为GPP患者带来新的治疗希望。","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":"","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":["BK4139","VNDA"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1130581087","title":"万达生物制药Imsidolimab治疗GPP的BLA申请获FDA受理，目标审评日期定于2026年12月12日","url":"https://stock-news.laohu8.com/highlight/detail?id=1130581087","media":"美股速递","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1130581087?lang=zh_cn&edition=full","pubTime":"2026-07-17 04:31","pubTimestamp":1784233873,"startTime":"0","endTime":"0","summary":"万达生物制药（Vanda Pharmaceuticals）用于治疗泛发性脓疱型银屑病（GPP）的候选药物Imsidolimab的生物制品许可申请（BLA），目前正处于美国食品药品监督管理局（FDA）的审评流程中。FDA已为该申请设定了目标审评日期，定为2026年12月12日。","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":"","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":null,"symbols":["BK4139","VNDA"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1143586895","title":"万达生物制药宣布其夏科-马里-图斯病2S型在研疗法获FDA儿科罕见病资格认定","url":"https://stock-news.laohu8.com/highlight/detail?id=1143586895","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1143586895?lang=zh_cn&edition=full","pubTime":"2026-07-08 04:31","pubTimestamp":1783456277,"startTime":"0","endTime":"0","summary":"万达生物制药近日宣布，其针对夏科-马里-图斯病2S型（Charcot-Marie-Tooth Disease Type 2S）的在研疗法，已获得美国食品药品监督管理局（FDA）授予的儿科罕见病资格认定。这一认定标志着该疗法在针对这一罕见儿科疾病的研究与开发进程中取得了重要进展。","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":"","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":["BK4139","VNDA"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1108747012","title":"日本授予Imsidolimab孤儿药资格，用于治疗泛发性脓疱型银屑病","url":"https://stock-news.laohu8.com/highlight/detail?id=1108747012","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1108747012?lang=zh_cn&edition=full","pubTime":"2026-05-27 19:07","pubTimestamp":1779880037,"startTime":"0","endTime":"0","summary":"日本监管机构已授予万达生物制药旗下在研药物Imsidolimab孤儿药资格，用于治疗泛发性脓疱型银屑病。\n这一认定旨在鼓励针对罕见疾病的药物开发，可能为该药未来在日本市场的审批与商业化提供路径支持。","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":"","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":["VNDA","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1172511226","title":"万达生物制药宣布Nereus™（Tradipitant）在美国上市，系40余年来首款晕动症新药","url":"https://stock-news.laohu8.com/highlight/detail?id=1172511226","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1172511226?lang=zh_cn&edition=full","pubTime":"2026-05-04 20:03","pubTimestamp":1777896224,"startTime":"0","endTime":"0","summary":"万达生物制药近日宣布，其研发的Nereus™（Tradipitant）已正式在美国市场投入商业销售。该药物成为四十多年来首款针对晕动症患者的新型药理治疗方案，标志着晕动症治疗领域迎来重大突破。\n此次上市意味着长期受晕动症困扰的患者将获得全新的治疗选择。Nereus™的推出不仅填补了该领域数十年的技术空白，更展现了医药创新对提升人类生活质量的持续推动力。","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":"","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":["VNDA","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1116493607","title":"万达生物制药：持有效处方患者可获Nereus药物 现金支付价为每剂85美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1116493607","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1116493607?lang=zh_cn&edition=full","pubTime":"2026-05-02 04:38","pubTimestamp":1777667891,"startTime":"0","endTime":"0","summary":"万达生物制药宣布，持有合规处方的患者现可通过现金支付方式获取Nereus药物，单剂定价为85美元。该方案为患者提供了直接购买渠道，无需经过传统保险报销流程。","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":"","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":["VNDA","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1140245743","title":"万达生物制药宣布Nereus™（Tradipitant）在美国上市，系四十余年来首款晕动症新药","url":"https://stock-news.laohu8.com/highlight/detail?id=1140245743","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1140245743?lang=zh_cn&edition=full","pubTime":"2026-05-02 04:37","pubTimestamp":1777667841,"startTime":"0","endTime":"0","summary":"美国医药市场迎来突破性进展——万达生物制药旗下新型晕动症治疗药物Nereus正式启动商业销售。这款神经激肽-1受体拮抗剂成为四十多年来首个针对晕动症的创新药理疗法，标志着该领域治疗空白终被填补。临床研究显示，口服Nereus能有效阻断引发恶心呕吐的关键神经信号通路。值得注意的是，该药物曾于2023年完成三期临床试验，数据显示用药组晕动症状发生率降低超70%。","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":"","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":["VNDA","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1154480528","title":"万达生物制药敦促FDA撤回2027财年立法议程中延长药物审评时限的提案","url":"https://stock-news.laohu8.com/highlight/detail?id=1154480528","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1154480528?lang=zh_cn&edition=full","pubTime":"2026-04-09 23:04","pubTimestamp":1775747053,"startTime":"0","endTime":"0","summary":"万达生物制药（Vanda Pharmaceuticals）近日呼吁美国食品药品监督管理局（FDA）从其2027财年立法议程中撤销一项旨在延长药物审评时间表的提案。该公司认为，此举可能对药物研发进程产生不利影响。","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":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["VNDA","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1118743082","title":"万达生物制药启动Thetis研究：评估Nereus™预防GLP-1受体激动剂所致呕吐的临床试验","url":"https://stock-news.laohu8.com/highlight/detail?id=1118743082","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1118743082?lang=zh_cn&edition=full","pubTime":"2026-04-09 04:46","pubTimestamp":1775681177,"startTime":"0","endTime":"0","summary":"万达生物制药宣布正式启动名为\"Thetis研究\"的临床试验，该试验旨在评估其创新药物Nereus对GLP-1受体激动剂引发的呕吐症状的预防效果。这项研究将针对使用GLP-1受体激动剂治疗时出现胃肠道不良反应的患者群体，探索Nereus在控制药物相关性呕吐方面的潜在疗效。若试验结果积极，Nereus有望成为首款专门针对GLP-1类药物相关呕吐症状的预防性疗法，为全球数百万相关患者提供新的解决方案。","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":"","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":["VNDA","BK4139"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1146656831","title":"欧洲药品管理局人用药品委员会：确认拒绝Hetlioz（塔西美尔通）营销授权变更的建议","url":"https://stock-news.laohu8.com/highlight/detail?id=1146656831","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1146656831?lang=zh_cn&edition=full","pubTime":"2026-03-27 19:45","pubTimestamp":1774611912,"startTime":"0","endTime":"0","summary":"欧洲药品管理局人用药品委员会（CHMP）已确认其建议，拒绝批准对Hetlioz（塔西美尔通）营销授权的变更申请。该决定维持了委员会早前的立场，意味着相关制药公司——万达生物制药（Vanda Pharmaceuticals）——此次申请未获通过。","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":"","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":["BK4139","VNDA"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1106740354","title":"万达生物制药呼吁FDA加速推动动物试验向人体相关方法转型","url":"https://stock-news.laohu8.com/highlight/detail?id=1106740354","media":"美股速递","labels":[],"top":-1,"itemType":null,"share":"https://www.laohunote.com/m/news/1106740354?lang=zh_cn&edition=full","pubTime":"2026-03-20 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