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18.31

-0.0700-0.38%

盘后：15.55-2.7600-15.07%19:13 EDT

成交量：101.38万

成交额：1,854.43万

市值：16.68亿

市盈率：-30.93

高：18.51

开：18.16

低：18.00

收：18.38

数据加载中...

总览公司新闻公告

【艾德生物：收到医疗器械变更注册文件】金融界2月20日消息，厦门艾德生物医药科技股份有限公司于近日收到国家药品监督管理局颁发的《医疗器械变更注册文件》，已完成“PD-L1抗体试剂（免疫组织化学法）”产品原注册证相关事项的变更。变更内容为预期用途增加相关表述。公司PD-L1抗体试剂已获批用于非小细胞肺癌、胃癌及胃食管交界处腺癌的伴随诊断。此次变更显著增强公司综合竞争力与市场拓展能力，产品实际销售情况取决于未来市场推广效果，尚无法预测对公司未来业绩的影响。

信达生物现涨超3% PD-1/IL-2α-bias双特异性抗体融合蛋白再获FDA快速通道资格认定

港股异动 | 信达生物(01801)涨超4% PD-1/IL-2α-bias双特异性抗体融合蛋白再获FDA快速通道资格认定

信达生物IBI363 (PD-1/IL-2α-bias双特异性抗体融合蛋白) 再获美国FDA快速通道资格认定，治疗鳞状非小细胞肺癌

百时美施贵宝PD-1+LAG-3组合疗法一项III期研究失败

医药魔方Info

神州细胞：控股子公司获得菲诺利单抗注射液注册证书

【复宏汉霖(02696.HK)：注射用HLX43用于治疗复发/转移性食管鳞癌(ESCC)的 2期临床研究于中国境内完成首例患者给药】复宏汉霖(02696.HK)公布，近日，一项注射用HLX43(靶向PD-L1 抗体-新型DNA拓扑异构酶I抑制剂偶联药物)(HLX43)在复发/转移性食管鳞癌患者中开展的2期临床研究于中国境内(不包括中国港澳台地区，下同)完成首例患者给药。公司亦计划于条件具备后开展用于宫颈癌、肝细胞癌、鼻咽癌、头颈部鳞癌、非小细胞肺癌等潜在适应症治疗的相关2期临床试验。

港股异动 | 君实生物(01877)涨超5% 抗PD-1单抗联合疗法纳入CDE突破性治疗品种名单

复宏汉霖抗PD-1单抗H药获欧盟批准，为广泛期小细胞肺癌患者带来新希望

【君实生物：AWT020注射用无菌粉末临床试验申请获批】君实生物公告，近日，公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，AWT020注射用无菌粉末（项目代号“JS213”）的临床试验申请获得批准。JS213是PD-1和白细胞介素-2双功能性抗体融合蛋白，主要用于晚期恶性肿瘤的治疗。

【复星医药：控股子公司药品获欧盟上市批准】金融界2月5日消息，上海复星医药（集团）股份有限公司控股子公司复宏汉霖自主研发的斯鲁利单抗注射液联合卡铂和依托泊苷适用于广泛期小细胞肺癌成人患者的一线治疗的上市许可申请近日获欧盟委员会批准。该药品为本集团自主研发的创新型抗PD-1单抗，在中国境内获批多个适应症，在欧盟、印度尼西亚、柬埔寨、泰国已获批上市。截至2024年12月，本集团针对该药品累计研发投入约为人民币298,271万元。2023年，靶向PD-1的单克隆抗体药品于全球范围的销售额约为399亿美元。复宏汉霖已授予 Intas Pharmaceuticals Ltd.于许可区域及许可领域独家商业化该药品的权利许可。本次获批将拓展该药品全球市场区域，提升本集团产品国际影响力。但药品销售情况受多种因素影响具有较大不确定性。

【君实生物：JS213 获得药物临床试验批准通知书】金融界2月5日消息，近日，君实生物收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，AWT020 注射用无菌粉末（项目代号“JS213”）的临床试验申请获得批准。JS213 是 PD-1 和白细胞介素-2 双功能性抗体融合蛋白，主要用于晚期恶性肿瘤的治疗。截至披露日，国内外尚无同类靶点双功能性抗体融合蛋白产品获批上市。JS213 在海外已进入 I 期临床试验阶段。药品研发周期长、环节多且有不确定性因素，敬请投资者谨慎决策，注意防范投资风险。公司将积极推进项目并按规定披露后续进展。

招银国际：维持三生制药(01530)“买入”评级 PD-1/VEGF双抗早期临床数据公布

【奥赛康：子公司在2025年ASCO GI发布创新药ASKB589治疗一线晚期胃癌研究成果】奥赛康1月24日早间公告，子公司ASKGENELIMITED于2025年1月23日在美国临床肿瘤学会胃肠道肿瘤研讨会上以壁报形式公布在研生物创新药 ASKB589联合CAPOX及PD-1抑制剂在晚期胃/食管胃交界处腺癌一线治疗的最新临床研究成果。本项研究中，ASKB589联合CAPOX以及PD-1抑制剂作为一线治疗方案，表现出显著的肿瘤缓解，且显示出持续的生存获益、良好的耐受性，联合PD-1抑制剂给药并未观察到额外的安全性风险。本研究结果支持开展以CLDN18.2中高表达的IV期胃/胃食管交界处腺癌患者为目标人群的ASKB589三联疗法III期临床研究。

科伦博泰生物-B新药抗PD-L1塔戈利单抗获批上市

科伦博泰生物-B(06990)：抗PD-L1塔戈利单抗获国家药监局批准上市

君实生物：与利奥制药签署分销与商业化协议

【券商聚焦】建银国际升百济神州(06160)目标价3.5% 指基本面改善料PD-1生物药为销售带来正面影响

建银国际升百济神州目标价4%至179港元今年基本面改善

首款狂犬病双抗在国内报上市、先声再明三抗新药授权艾伯维、默沙东 PD-1 单抗在国内获批新适应症

医药经济报

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(PD-1/IL-2α-bias双特异性抗体融合蛋白) 再获美国FDA快速通道资格认定，治疗鳞状非小细胞肺癌","url":"https://stock-news.laohu8.com/highlight/detail?id=2512966214","media":"美通社","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512966214?lang=zh_cn&edition=fundamental","pubTime":"2025-02-17 08:00","pubTimestamp":1739750400,"startTime":"0","endTime":"0","summary":"旧金山和中国苏州2025年2月17日 /美通社/ -- 信达生物制药集团，一家致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域创新药物的生物制药公司，宣布其PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363获得美国食品和药物监督管理局授予快速通道资格，拟定适应症为抗PD-1免疫检查点抑制剂及含铂化疗治疗后进展的局部晚期或转移性鳞状非小细胞肺癌。","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/4620398_ZH20398_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":["BK1589","LU2328871848.SGD","BK1161","IVBIY","BK4139","LU2488822045.USD","PD","LU1169590202.USD","01801","LU1969619763.USD","BK1583","BK4023","LU1169589451.USD"],"gpt_icon":0},{"id":"2511365712","title":"百时美施贵宝PD-1+LAG-3组合疗法一项III期研究失败","url":"https://stock-news.laohu8.com/highlight/detail?id=2511365712","media":"医药魔方Info","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2511365712?lang=zh_cn&edition=fundamental","pubTime":"2025-02-14 16:55","pubTimestamp":1739523355,"startTime":"0","endTime":"0","summary":"Opdualag是首个获得批准的PD-1+LAG-3组合抗体疗法，2022年3月，FDA批准该药用于治疗患有不可切除或转移性黑色素瘤的12岁及以上儿童和成人患者。临床前研究表明，抑制LAG-3可能促进抗肿瘤反应，同时抑制LAG-3和PD-1可能会增强某些癌症的抗肿瘤反应，从而使治疗效果优于PD-1单药治疗。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250214172812abceb7cb&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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16:03","pubTimestamp":1739260999,"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.ushknews.com/","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_meigang","symbols":["LU1169590202.USD","688520","LU1169589451.USD","BK0239","PD","BK4023"],"gpt_icon":0},{"id":"2510310168","title":"【复宏汉霖(02696.HK)：注射用HLX43用于治疗复发/转移性食管鳞癌(ESCC)的 2期临床研究于中国境内完成首例患者给药】复宏汉霖(02696.HK)公布，近日，一项注射用HLX43(靶向PD-L1 抗体-新型DNA拓扑异构酶I抑制剂偶联药物)(HLX43)在复发/转移性食管鳞癌患者中开展的2期临床研究于中国境内(不包括中国港澳台地区，下同)完成首例患者给药。公司亦计划于条件具备后开展用于宫颈癌、肝细胞癌、鼻咽癌、头颈部鳞癌、非小细胞肺癌等潜在适应症治疗的相关2期临床试验。","url":"https://stock-news.laohu8.com/highlight/detail?id=2510310168","media":"金融界","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2510310168?lang=zh_cn&edition=fundamental","pubTime":"2025-02-10 17:55","pubTimestamp":1739181317,"startTime":"0","endTime":"0","summary":"复宏汉霖(02696.HK)公布，近日，一项注射用HLX43(靶向PD-L1 抗体-新型DNA拓扑异构酶I抑制剂偶联药物)(HLX43)在复发/转移性食管鳞癌患者中开展的2期临床研究于中国境内(不包括中国港澳台地区，下同)完成首例患者给药。公司亦计划于条件具备后开展用于宫颈癌、肝细胞癌、鼻咽癌、头颈部鳞癌、非小细胞肺癌等潜在适应症治疗的相关2期临床试验。","market":"hk","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/2025/02/10175548051748.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":"jinrongjie_stock","symbols":["BK4023","BK4139","03347","DNA","BK4109","PD","BK1576","BK1583","BK1161","LU1169589451.USD","LU1169590202.USD","BK1141","02696"],"gpt_icon":0},{"id":"2510437009","title":"港股异动 | 君实生物(01877)涨超5% 抗PD-1单抗联合疗法纳入CDE突破性治疗品种名单","url":"https://stock-news.laohu8.com/highlight/detail?id=2510437009","media":"智通财经","labels":["productRelease","movement"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2510437009?lang=zh_cn&edition=fundamental","pubTime":"2025-02-10 11:52","pubTimestamp":1739159578,"startTime":"0","endTime":"0","summary":"消息面上，君实生物近日宣布，由公司自主研发的抗PD-1单抗药物特瑞普利单抗联合迈威生物自主研发的靶向Nectin-4抗体偶联药物创新药近日被国家药品监督管理局药品审评中心纳入突破性治疗品种名单。本次纳入的适应症为特瑞普利单抗联合9MW2821用于治疗既往未经系统治疗的、不可手术切除的局部晚期或转移性尿路上皮癌。据悉，JS213是PD-1和白细胞介素-2双功能性抗体融合蛋白，主要用于晚期恶性肿瘤的治疗。此外，JS213具有良好、可接受的安全性和耐受性。","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/1247623.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease,movement","news_rank":0,"length":0,"strategy_id":0,"source":"stock_zhitongcaijing","symbols":["LU1169589451.USD","LU1169590202.USD","BK0239","688180","01877","PD","BK1583","BK4017","BK4023","BK1515","CDE","BK1161"],"gpt_icon":0},{"id":"2509028463","title":"复宏汉霖抗PD-1单抗H药获欧盟批准，为广泛期小细胞肺癌患者带来新希望","url":"https://stock-news.laohu8.com/highlight/detail?id=2509028463","media":"金融界","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509028463?lang=zh_cn&edition=fundamental","pubTime":"2025-02-05 22:18","pubTimestamp":1738765082,"startTime":"0","endTime":"0","summary":"2月5日，复宏汉霖宣布了一项重大突破：其自主研发的抗PD-1单抗H药——汉斯状正式获得欧盟委员会的批准，联合卡铂和依托泊苷用于广泛期小细胞肺癌成人患者的一线治疗。这一里程碑式的成就标志着H药成为首个且唯一在欧盟获批上市用于广泛期小细胞肺癌治疗的抗PD-1单抗，为全球小细胞肺癌患者带来了新的治疗曙光。","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://finance.jrj.com.cn/2025/02/05221847974225.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":"jinrongjie_stock","symbols":["BK0028","LU1169590202.USD","BK0183","BK0196","LU1169589451.USD","BK0187","BK4023","000876","BK0188","BK1161","BK0238","02696","PD","BK0012"],"gpt_icon":0},{"id":"2509283811","title":"【君实生物：AWT020注射用无菌粉末临床试验申请获批】君实生物公告，近日，公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，AWT020注射用无菌粉末（项目代号“JS213”）的临床试验申请获得批准。JS213是PD-1和白细胞介素-2双功能性抗体融合蛋白，主要用于晚期恶性肿瘤的治疗。","url":"https://stock-news.laohu8.com/highlight/detail?id=2509283811","media":"金融界","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509283811?lang=zh_cn&edition=fundamental","pubTime":"2025-02-05 20:50","pubTimestamp":1738759828,"startTime":"0","endTime":"0","summary":"君实生物公告，近日，公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，AWT020注射用无菌粉末（项目代号“JS213”）的临床试验申请获得批准。JS213是PD-1和白细胞介素-2双功能性抗体融合蛋白，主要用于晚期恶性肿瘤的治疗。","market":"hk","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/2025/02/05205047971799.shtml","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":"jinrongjie_stock","symbols":["BK1141","BK4023","PD","BK1576","BK1161","BK1515","BK0239","01877","03347","BK1583","LU1169590202.USD","LU1169589451.USD","688180"],"gpt_icon":0},{"id":"2509069434","title":"【复星医药：控股子公司药品获欧盟上市批准】金融界2月5日消息，上海复星医药（集团）股份有限公司控股子公司复宏汉霖自主研发的斯鲁利单抗注射液联合卡铂和依托泊苷适用于广泛期小细胞肺癌成人患者的一线治疗的上市许可申请近日获欧盟委员会批准。该药品为本集团自主研发的创新型抗PD-1单抗，在中国境内获批多个适应症，在欧盟、印度尼西亚、柬埔寨、泰国已获批上市。截至2024年12月，本集团针对该药品累计研发投入约为人民币298,271万元。2023年，靶向PD-1的单克隆抗体药品于全球范围的销售额约为399亿美元。复宏汉霖已授予 Intas Pharmaceuticals Ltd.于许可区域及许可领域独家商业化该药品的权利许可。本次获批将拓展该药品全球市场区域，提升本集团产品国际影响力。但药品销售情况受多种因素影响具有较大不确定性。","url":"https://stock-news.laohu8.com/highlight/detail?id=2509069434","media":"金融界","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509069434?lang=zh_cn&edition=fundamental","pubTime":"2025-02-05 18:52","pubTimestamp":1738752748,"startTime":"0","endTime":"0","summary":"截至2024年12月，本集团针对该药品累计研发投入约为人民币298,271万元。2023年，靶向PD-1的单克隆抗体药品于全球范围的销售额约为399亿美元。本次获批将拓展该药品全球市场区域，提升本集团产品国际影响力。但药品销售情况受多种因素影响具有较大不确定性。","market":"hk","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/2025/02/05185247963837.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":["BK4023","BK1161","BK0183","BK1515","PD","BK1593","LU1169589451.USD","02696","BK0175","BK0187","02196","BK1191","BK0096","BK0060","BK0188","BK0012","LU1169590202.USD","BK0028","BK0196","BK0239","600196"],"gpt_icon":0},{"id":"2509740583","title":"【君实生物：JS213 获得药物临床试验批准通知书】金融界2月5日消息，近日，君实生物收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，AWT020 注射用无菌粉末（项目代号“JS213”）的临床试验申请获得批准。JS213 是 PD-1 和白细胞介素-2 双功能性抗体融合蛋白，主要用于晚期恶性肿瘤的治疗。截至披露日，国内外尚无同类靶点双功能性抗体融合蛋白产品获批上市。JS213 在海外已进入 I 期临床试验阶段。药品研发周期长、环节多且有不确定性因素，敬请投资者谨慎决策，注意防范投资风险。公司将积极推进项目并按规定披露后续进展。","url":"https://stock-news.laohu8.com/highlight/detail?id=2509740583","media":"金融界","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509740583?lang=zh_cn&edition=fundamental","pubTime":"2025-02-05 18:22","pubTimestamp":1738750955,"startTime":"0","endTime":"0","summary":"金融界2月5日消息，近日，君实生物收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，AWT020 注射用无菌粉末（项目代号“JS213”）的临床试验申请获得批准。JS213 是 PD-1 和白细胞介素-2 双功能性抗体融合蛋白，主要用于晚期恶性肿瘤的治疗。截至披露日，国内外尚无同类靶点双功能性抗体融合蛋白产品获批上市。JS213 在海外已进入 I 期临床试验阶段。药品研发周期长、环节多且有不确定性因素，敬请投资者谨慎决策，注意防范投资风险。公司将积极推进项目并按规定披露后续进展。","market":"hk","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/2025/02/05182247963388.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":"jinrongjie_stock","symbols":["688180","03347","BK1161","LU1169590202.USD","BK1576","BK1515","BK1583","PD","01877","BK4023","LU1169589451.USD","BK0239","BK1141"],"gpt_icon":0},{"id":"2508164624","title":"招银国际：维持三生制药(01530)“买入”评级 PD-1/VEGF双抗早期临床数据公布","url":"https://stock-news.laohu8.com/highlight/detail?id=2508164624","media":"智通财经","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2508164624?lang=zh_cn&edition=fundamental","pubTime":"2025-02-03 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ASKB589联合CAPOX及PD-1抑制剂在晚期胃/食管胃交界处腺癌一线治疗的最新临床研究成果。本项研究中，ASKB589联合CAPOX以及PD-1抑制剂作为一线治疗方案，表现出显著的肿瘤缓解，且显示出持续的生存获益、良好的耐受性，联合PD-1抑制剂给药并未观察到额外的安全性风险。本研究结果支持开展以CLDN18.2中高表达的IV期胃/胃食管交界处腺癌患者为目标人群的ASKB589三联疗法III期临床研究。","url":"https://stock-news.laohu8.com/highlight/detail?id=2505893076","media":"金融界","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2505893076?lang=zh_cn&edition=fundamental","pubTime":"2025-01-24 08:14","pubTimestamp":1737677649,"startTime":"0","endTime":"0","summary":"奥赛康1月24日早间公告，子公司ASKGENELIMITED于2025年1月23日在美国临床肿瘤学会胃肠道肿瘤研讨会上以壁报形式公布在研生物创新药 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