688177 百奥泰
已收盘 06-26 15:00:00
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每周股票复盘:百奥泰(688177)永和工厂EU GMP检查结果公布
证券之星 · 06-20
每周股票复盘:百奥泰(688177)永和工厂EU GMP检查结果公布
百奥泰:CAPA措施已基本认同
证券之星 · 06-18
百奥泰:CAPA措施已基本认同
百奥泰:艾沙力®/喜沙立®(乌司奴单抗)正按计划推进商业化准备工作
证券之星 · 06-18
百奥泰:艾沙力®/喜沙立®(乌司奴单抗)正按计划推进商业化准备工作
百奥泰:公司近期已向美国市场正常供货
证券之星 · 06-18
百奥泰:公司近期已向美国市场正常供货
百奥泰:公司将暂停欧洲市场的供货并已启动全面整改
证券之星 · 06-17
百奥泰:公司将暂停欧洲市场的供货并已启动全面整改
百奥泰(688177)披露永和工厂EU GMP检查情况公告,6月16日股价下跌0.59%
证券之星 · 06-16
百奥泰(688177)披露永和工厂EU GMP检查情况公告,6月16日股价下跌0.59%
百奥泰宣布已整改 此前欧盟GMP检查发现偏差管理措施不足
美股速递 · 06-14
百奥泰宣布已整改 此前欧盟GMP检查发现偏差管理措施不足
百奥泰最新公告:永和工厂制剂部分不符合EUGMP要求
证券之星 · 06-14
百奥泰最新公告:永和工厂制剂部分不符合EUGMP要求
百奥泰:6月12日接受机构调研,自然人股东参与
证券之星 · 06-13
百奥泰:6月12日接受机构调研,自然人股东参与
百奥泰:公司于2026年5月11日参加科创板企业成果转化与民生赋能之2025年度制药行业集体业绩说明会暨召开2026年第一季度业绩说明会
证券之星 · 06-11
百奥泰:公司于2026年5月11日参加科创板企业成果转化与民生赋能之2025年度制药行业集体业绩说明会暨召开2026年第一季度业绩说明会
百奥泰:BAT2306(司库奇尤单抗)正在进行核准工艺和标准
证券之星 · 06-11
百奥泰:BAT2306(司库奇尤单抗)正在进行核准工艺和标准
百奥泰最新公告:BAT2206获得新加坡HSA上市批准
证券之星 · 06-10
百奥泰最新公告:BAT2206获得新加坡HSA上市批准
股市必读:百奥泰(688177)6月2日董秘有最新回复
证券之星 · 06-03
股市必读:百奥泰(688177)6月2日董秘有最新回复
百奥泰:BAT8006正在国内进行单药用于铂耐药卵巢癌适应症的关键注册III期临床试验
证券之星 · 06-02
百奥泰:BAT8006正在国内进行单药用于铂耐药卵巢癌适应症的关键注册III期临床试验
每周股票复盘:百奥泰(688177)戈利木单抗获FDA上市批准
证券之星 · 05-24
每周股票复盘:百奥泰(688177)戈利木单抗获FDA上市批准
百奥泰(688177.SH):艾沙力®/喜沙立®(乌司奴单抗注射液)获得药品注册证书
智通财经 · 05-21
百奥泰(688177.SH):艾沙力®/喜沙立®(乌司奴单抗注射液)获得药品注册证书
百奥泰(688177)披露2025年年度股东会决议公告,5月20日股价下跌1.16%
证券之星 · 05-20
百奥泰(688177)披露2025年年度股东会决议公告,5月20日股价下跌1.16%
百奥泰戈利木单抗生物类似药获FDA批准 成Simponi®及Simponi Aria®首个生物类似药;Accord Biopharma将在美商业化Immgolis™与Immgolis Intri™
美股速递 · 05-18
百奥泰戈利木单抗生物类似药获FDA批准 成Simponi®及Simponi Aria®首个生物类似药;Accord Biopharma将在美商业化Immgolis™与Immgolis Intri™
百奥泰(688177)披露戈利木单抗注射液获美国FDA上市批准公告,5月18日股价下跌0.61%
证券之星 · 05-18
百奥泰(688177)披露戈利木单抗注射液获美国FDA上市批准公告,5月18日股价下跌0.61%
百奥泰(688177.SH):BAT2506获美国FDA上市批准
智通财经 · 05-18
百奥泰(688177.SH):BAT2506获美国FDA上市批准
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公司概况
公司名称:
百奥泰生物制药股份有限公司
所属行业:
医药制造业
上市日期:
2020-02-21
主营业务:
百奥泰生物制药股份有限公司的主营业务是创新药和生物类似药的研发。公司的主要产品是自身免疫药物、抗肿瘤药物。公司被认定为国家高新技术企业、国家工业企业知识产权运用试点企业、国家知识产权优势企业、广东省新型研发机构、广东省工程技术研究中心、广东省工程实验室、广东省企业技术中心、广东省制造业单项冠军企业。
发行价格:
32.76
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GMP检查结果公布","url":"https://stock-news.laohu8.com/highlight/detail?id=2644663090","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2644663090?lang=zh_cn&edition=full","pubTime":"2026-06-20 03:41","pubTimestamp":1781898070,"startTime":"0","endTime":"0","summary":"截至2026年6月18日收盘,百奥泰报收于17.06元,较上周的17.33元下跌1.56%。本周,百奥泰6月15日盘中最高价报17.38元。本周关注点公司公告汇总:百奥泰永和工厂EU GMP检查中制剂部分不符合要求,原液部分符合要求。公司公告汇总百奥泰生物制药股份有限公司于2026年2月4日至2月12日接受法国国家药品与健康产品安全局的EU GMP现场检查。公司已积极整改并获检查机构基本认同,需后续现场核实。公司已获得FDA新药上市批准,国内业务运营正常。","market":"fut","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://stock.stockstar.com/RB2026062000002153.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":"stockstar","symbols":["688177","BK0239"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644049227","title":"百奥泰:CAPA措施已基本认同","url":"https://stock-news.laohu8.com/highlight/detail?id=2644049227","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2644049227?lang=zh_cn&edition=full","pubTime":"2026-06-18 17:54","pubTimestamp":1781776451,"startTime":"0","endTime":"0","summary":"证券之星消息,百奥泰06月18日在投资者关系平台上答复投资者关心的问题。投资者提问:公司从2025年收到FDA483表时到欧盟发NCR之间做了哪些质量提升的工作,面对CAPA整改不被认可,生产环节质量体系的崩塌,内部有对质量负责人进行问责么?CAPA措施已基本认同,目前公司主要精力集中在整改问题、解决问题上,并投入更多人力资源到质量管理体系中,后续会根据公司的管理制度对相应的人员做出公允的绩效考评。","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":"https://stock.stockstar.com/RB2026061800032069.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":"stockstar","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644998704","title":"百奥泰:艾沙力®/喜沙立®(乌司奴单抗)正按计划推进商业化准备工作","url":"https://stock-news.laohu8.com/highlight/detail?id=2644998704","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2644998704?lang=zh_cn&edition=full","pubTime":"2026-06-18 17:54","pubTimestamp":1781776450,"startTime":"0","endTime":"0","summary":"证券之星消息,百奥泰06月18日在投资者关系平台上答复投资者关心的问题。如果不涉及商业机密,请能够及时回复,谢谢!公司已启动全面整改对偏差调查程序存在不足的地方进行优化,包括聘请欧盟GMP专家培训等,持续提高整体质量管理体系。艾沙力/喜沙立正按计划推进商业化准备工作。","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":"https://stock.stockstar.com/RB2026061800032063.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":"stockstar","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644704991","title":"百奥泰:公司近期已向美国市场正常供货","url":"https://stock-news.laohu8.com/highlight/detail?id=2644704991","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2644704991?lang=zh_cn&edition=full","pubTime":"2026-06-18 17:54","pubTimestamp":1781776450,"startTime":"0","endTime":"0","summary":"证券之星消息,百奥泰06月18日在投资者关系平台上答复投资者关心的问题。若没有的话,公司是否对此有预案——如果欧美同时被禁?公司近期已向美国市场正常供货,美国GMP认证由FDA独立评估完成,目前未受欧盟检查影响。感谢您对公司的关注!","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":"https://stock.stockstar.com/RB2026061800032062.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":"stockstar","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644711598","title":"百奥泰:公司将暂停欧洲市场的供货并已启动全面整改","url":"https://stock-news.laohu8.com/highlight/detail?id=2644711598","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2644711598?lang=zh_cn&edition=full","pubTime":"2026-06-17 16:09","pubTimestamp":1781683766,"startTime":"0","endTime":"0","summary":"公司已于近期获得美国FDA新药上市批准,国内业务运营秩序良好。公司近期已向美国市场正常供货,美国GMP认证由FDA独立评估完成,目前未受欧盟检查影响。公司将暂停欧洲市场的供货并已启动全面整改,包括升版偏差管理规程、聘请欧美GMP顾问团队进行全员培训等,力争从根本上提升质量体系。公司将正视问题、落实整改,尽最大努力缩短影响周期,争取早日通过复核。","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":"https://stock.stockstar.com/RB2026061700025792.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":"stockstar","symbols":["688177","BK0239"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2643590957","title":"百奥泰(688177)披露永和工厂EU GMP检查情况公告,6月16日股价下跌0.59%","url":"https://stock-news.laohu8.com/highlight/detail?id=2643590957","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2643590957?lang=zh_cn&edition=full","pubTime":"2026-06-16 19:02","pubTimestamp":1781607728,"startTime":"0","endTime":"0","summary":"截至2026年6月16日收盘,百奥泰报收于16.8元,较前一交易日下跌0.59%,最新总市值为69.57亿元。该股当日开盘16.86元,最高16.96元,最低16.52元,成交额达4963.35万元,换手率为0.71%。近日,百奥泰生物制药股份有限公司发布《关于永和工厂EU GMP检查情况的公告》。公告显示,公司于2026年2月4日至2月12日接受法国国家药品与健康产品安全局的EU GMP现场检查。公司已积极整改并获检查机构基本认同,需后续现场核实。公司已获得FDA新药上市批准,国内业务运营正常。","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":"https://stock.stockstar.com/RB2026061600036883.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":"stockstar","symbols":["688177","BK0239"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1134304925","title":"百奥泰宣布已整改 此前欧盟GMP检查发现偏差管理措施不足","url":"https://stock-news.laohu8.com/highlight/detail?id=1134304925","media":"美股速递","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/1134304925?lang=zh_cn&edition=full","pubTime":"2026-06-14 16:19","pubTimestamp":1781425160,"startTime":"0","endTime":"0","summary":"百奥泰表示,在欧盟药品生产质量管理规范(GMP)检查结果揭示其偏差管理措施存在不足后,公司已采取相应整改行动。\n此次检查发现的缺陷主要涉及偏差管理程序的不完善。百奥泰称,相关问题已得到及时纠正,并已实施改进措施以确保生产质量管理体系完全符合欧盟GMP的严格要求。\n公司强调,始终致力于维持最高的质量标准,并将持续优化其质量管理流程。","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":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2643624669","title":"百奥泰最新公告:永和工厂制剂部分不符合EUGMP要求","url":"https://stock-news.laohu8.com/highlight/detail?id=2643624669","media":"证券之星","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2643624669?lang=zh_cn&edition=full","pubTime":"2026-06-14 16:09","pubTimestamp":1781424569,"startTime":"0","endTime":"0","summary":"百奥泰公告称,公司于2026年2月4日至2月12日接受了法国国家药品与健康产品安全局针对欧盟药品生产质量管理规范符合性的现场检查。近日,欧洲药品管理局通告了针对本次GMP检查的结果如下:原液部分符合EUGMP要求,GMP证书已更新;制剂部分不符合EUGMP要求,缺陷主要涉及到公司永和工厂存在偏差管理相关措施不到位的问题。欧洲区域授权许可收入及供货收入目前对公司整体经营业绩影响较小。公司将积极与ANSM和EMA进行沟通,争取早日完成复核。","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":"https://stock.stockstar.com/RB2026061400002568.shtml","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":"stockstar","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2643926322","title":"百奥泰:6月12日接受机构调研,自然人股东参与","url":"https://stock-news.laohu8.com/highlight/detail?id=2643926322","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2643926322?lang=zh_cn&edition=full","pubTime":"2026-06-13 00:01","pubTimestamp":1781280089,"startTime":"0","endTime":"0","summary":"证券之星消息,2026年6月12日百奥泰发布公告称公司于2026年6月12日接受机构调研,自然人股东参与。目前 BT8006 已在开展铂耐药卵巢癌的 III 期研究,入组已过半。百奥泰主营业务:药物的研发、生产和销售。融资融券数据显示该股近3个月融资净流出691.88万,融资余额减少;融券净流出27.88万,融券余额减少。","market":"fut","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://stock.stockstar.com/RB2026061300000021.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":"stockstar","symbols":["688177","BK0239"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2642400992","title":"百奥泰:公司于2026年5月11日参加科创板企业成果转化与民生赋能之2025年度制药行业集体业绩说明会暨召开2026年第一季度业绩说明会","url":"https://stock-news.laohu8.com/highlight/detail?id=2642400992","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2642400992?lang=zh_cn&edition=full","pubTime":"2026-06-11 16:54","pubTimestamp":1781168056,"startTime":"0","endTime":"0","summary":"证券之星消息,百奥泰06月11日在投资者关系平台上答复投资者关心的问题。公司于2026年5月11日在上海证券交易所上证路演中心参加了十五五·科创惠民——科创板企业成果转化与民生赋能之2025年度制药行业集体业绩说明会暨召开2026年第一季度业绩说明会,说明会中对公司2025年年度及2026年第一季度的经营情况做了详细解读,公司也对投资者关注的问题做了回复并披露了投资者关系活动记录表。","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":"https://stock.stockstar.com/RB2026061100026318.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":"stockstar","symbols":["159982","BK1574","01477","BK1191","BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2642400563","title":"百奥泰:BAT2306(司库奇尤单抗)正在进行核准工艺和标准","url":"https://stock-news.laohu8.com/highlight/detail?id=2642400563","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2642400563?lang=zh_cn&edition=full","pubTime":"2026-06-11 16:48","pubTimestamp":1781167705,"startTime":"0","endTime":"0","summary":"证券之星消息,百奥泰(688177)06月11日在投资者关系平台上答复投资者关心的问题。投资者提问:尊敬的董秘您好。司库奇尤单抗是再次发补了吗?如果是,预计何时完成第二轮补充资料提交?如果不是,是什么原因导致NMPA审评暂停?百奥泰回复:尊敬的投资者您好!公司BAT2306(司库奇尤单抗)正在进行核准工艺和标准,新药上市申请的审批时间和过程具有不确定性,公司一直在积极跟进并推动相关进程。感谢您对公司的关注!本文数据来源于上海证券交易所e互动,仅供参考不构成投资建议。","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":"https://stock.stockstar.com/RB2026061100026197.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":"stockstar","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2642442737","title":"百奥泰最新公告:BAT2206获得新加坡HSA上市批准","url":"https://stock-news.laohu8.com/highlight/detail?id=2642442737","media":"证券之星","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2642442737?lang=zh_cn&edition=full","pubTime":"2026-06-10 17:44","pubTimestamp":1781084641,"startTime":"0","endTime":"0","summary":"百奥泰(688177.SH)公告称,公司收到新加坡HSA签发的关于BAT2206(乌司奴单抗注射液)上市批准通知。该药品用于治疗中重度斑块状银屑病、活动性银屑病关节炎、中重度活动性克罗恩病等适应症。截至目前,BAT2206已获中国、美国、欧盟、新加坡、英国等地批准上市,商业化授权覆盖全球71个国家和地区。以上内容为证券之星据公开信息整理,仅供参考不构成投资建议。","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":"https://stock.stockstar.com/RB2026061000031579.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":"stockstar","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640892852","title":"股市必读:百奥泰(688177)6月2日董秘有最新回复","url":"https://stock-news.laohu8.com/highlight/detail?id=2640892852","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2640892852?lang=zh_cn&edition=full","pubTime":"2026-06-03 02:58","pubTimestamp":1780426691,"startTime":"0","endTime":"0","summary":"截至2026年6月2日收盘,百奥泰报收于18.39元,下跌3.92%,换手率0.8%,成交量3.3万手,成交额6136.28万元。董秘最新回复投资者: 去年8月交流会上表示BAT8006正在和FDA沟通国际临床。BAT8006正在国内进行单药用于铂耐药卵巢癌适应症的关键注册III期临床试验,感谢您对公司的关注!来自交易信息汇总:散户资金净流入835.76万元,占总成交额13.62%,表明中小投资者今日参与积极性较高。","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":"https://stock.stockstar.com/RB2026060300002795.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":"stockstar","symbols":["688177","BK0239"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2640199219","title":"百奥泰:BAT8006正在国内进行单药用于铂耐药卵巢癌适应症的关键注册III期临床试验","url":"https://stock-news.laohu8.com/highlight/detail?id=2640199219","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2640199219?lang=zh_cn&edition=full","pubTime":"2026-06-02 17:24","pubTimestamp":1780392256,"startTime":"0","endTime":"0","summary":"证券之星消息,百奥泰(688177)06月02日在投资者关系平台上答复投资者关心的问题。投资者提问:去年8月交流会上表示BAT8006正在和FDA沟通国际临床。相关沟通截止2026年5月是否有新的进展?预计何时会开启国际临床?百奥泰回复:尊敬的投资者您好! BAT8006正在国内进行单药用于铂耐药卵巢癌适应症的关键注册III期临床试验,感谢您对公司的关注!本文数据来源于上海证券交易所e互动,仅供参考不构成投资建议。","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":"https://stock.stockstar.com/RB2026060200033128.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":"stockstar","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2637375535","title":"每周股票复盘:百奥泰(688177)戈利木单抗获FDA上市批准","url":"https://stock-news.laohu8.com/highlight/detail?id=2637375535","media":"证券之星","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2637375535?lang=zh_cn&edition=full","pubTime":"2026-05-24 03:27","pubTimestamp":1779564431,"startTime":"0","endTime":"0","summary":"截至2026年5月22日收盘,百奥泰报收于20.1元,较上周的19.58元上涨2.66%。本周关注点来自公司公告汇总:百奥泰戈利木单抗注射液获美国FDA上市批准,适应症为类风湿关节炎和溃疡性结肠炎。公司公告汇总百奥泰生物制药股份有限公司收到美国食品药品监督管理局通知,其戈利木单抗注射液已获准上市。BAT2206已获美国FDA和欧洲EMA批准上市,并在全球71个国家和地区达成商业化授权合作。","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":"https://stock.stockstar.com/RB2026052400000990.shtml","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":"stockstar","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2637892813","title":"百奥泰(688177.SH):艾沙力®/喜沙立®(乌司奴单抗注射液)获得药品注册证书","url":"https://stock-news.laohu8.com/highlight/detail?id=2637892813","media":"智通财经","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2637892813?lang=zh_cn&edition=full","pubTime":"2026-05-21 17:34","pubTimestamp":1779356051,"startTime":"0","endTime":"0","summary":"智通财经APP讯,百奥泰 发布公告,公司于近日收到了国家药品监督管理局核准签发的关于乌司奴单抗注射液和乌司奴单抗注射液的《药品注册证书》。BAT2206是百奥泰根据NMPA、美国食品药品监督管理局、欧洲药品管理局生物类似药相关指导原则开发的乌司奴单抗注射液,乌司奴单抗是一款靶向白细胞介素IL-12和IL-23共有的 p40 亚基的全人源单克隆抗体。截至本公告披露日,BAT2206已获得FDA和EMA批准上市,美国注册商品名称为Starjemza,欧洲注册商品名为Usymro。","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/1444542.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":"百奥泰(688177.SH):艾沙力®/喜沙立®(乌司奴单抗注射液)获得药品注册证书","news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"stock_zhitongcaijing","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2636845313","title":"百奥泰(688177)披露2025年年度股东会决议公告,5月20日股价下跌1.16%","url":"https://stock-news.laohu8.com/highlight/detail?id=2636845313","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2636845313?lang=zh_cn&edition=full","pubTime":"2026-05-20 18:18","pubTimestamp":1779272303,"startTime":"0","endTime":"0","summary":"截至2026年5月20日收盘,百奥泰报收于19.57元,较前一交易日下跌1.16%,最新总市值为81.04亿元。百奥泰于近日披露《2025年年度股东会决议公告》。公告显示,公司于2026年5月19日召开2025年年度股东会,会议审议通过了《关于公司2025年年度报告及其摘要的议案》《关于公司2025年度董事会工作报告的议案》《关于公司2025年度利润分配预案的议案》等九项议案。出席会议的股东及代理人共131人,代表有表决权股份总数的70.3817%。","market":"fut","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://stock.stockstar.com/RB2026052000035289.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":"stockstar","symbols":["688177","BK0239"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"1110463142","title":"百奥泰戈利木单抗生物类似药获FDA批准 成Simponi®及Simponi Aria®首个生物类似药;Accord Biopharma将在美商业化Immgolis™与Immgolis Intri™","url":"https://stock-news.laohu8.com/highlight/detail?id=1110463142","media":"美股速递","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/1110463142?lang=zh_cn&edition=full","pubTime":"2026-05-18 20:00","pubTimestamp":1779105640,"startTime":"0","endTime":"0","summary":"百奥泰的戈利木单抗生物类似药已获得美国食品药品监督管理局(FDA)的批准,成为强生旗下Simponi®及Simponi Aria®的首个生物类似药。根据协议,Accord Biopharma将负责在美国市场商业化这两款产品,即Immgolis™(戈利木单抗-Sldi)与Immgolis Intri™(戈利木单抗-Sldi)。","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":["688177","BK0239"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2636027640","title":"百奥泰(688177)披露戈利木单抗注射液获美国FDA上市批准公告,5月18日股价下跌0.61%","url":"https://stock-news.laohu8.com/highlight/detail?id=2636027640","media":"证券之星","labels":[],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2636027640?lang=zh_cn&edition=full","pubTime":"2026-05-18 18:58","pubTimestamp":1779101895,"startTime":"0","endTime":"0","summary":"截至2026年5月18日收盘,百奥泰报收于19.46元,较前一交易日下跌0.61%,最新总市值为80.58亿元。该股当日开盘19.61元,最高19.63元,最低19.21元,成交额达3674.5万元,换手率为0.46%。近日,百奥泰生物制药股份有限公司披露关于Immgolis/ Immgolis Intri获美国FDA上市批准的公告。公告显示,公司收到美国食品药品监督管理局通知,其戈利木单抗注射液已获准上市。产品已获FDA和EMA批准,正在多个国家和地区申报上市,并已与多家企业达成商业化授权合作,覆盖118个国家和地区。","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":"https://stock.stockstar.com/RB2026051800030119.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":"stockstar","symbols":["BK0239","688177"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2636024622","title":"百奥泰(688177.SH):BAT2506获美国FDA上市批准","url":"https://stock-news.laohu8.com/highlight/detail?id=2636024622","media":"智通财经","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://www.laohu8.com/m/news/2636024622?lang=zh_cn&edition=full","pubTime":"2026-05-18 17:58","pubTimestamp":1779098337,"startTime":"0","endTime":"0","summary":"智通财经APP讯,百奥泰 发布公告,公司于近日收到美国食品药品监督管理局签发的关于Immgolis/Immgolis Intri上市批准通知。据悉,BAT2506是百奥泰根据中国国家药品监督管理局、FDA、欧洲药品管理局生物类似药相关指导原则开发的戈利木单抗生物类似药。截至本公告披露日,BAT2506已获得FDA、EMA上市批准,美国商品名为Immgolis/Immgolis 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