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基石药业PD-1/VEGF/CTLA-4三抗CS2009全球多中心I期临床试验完成首例患者给药

每日经济新闻

【基石药业-B(02616.HK)：PD-1/VEGF/CTLA-4三特异性抗体CS2009全球多中心I期临床试验顺利完成首例患者给药】基石药业-B(02616.HK)发布公告，公司自主研发的PD-1/VEGF/CTLA-4三特异性抗体CS2009的全球多中心I期临床试验顺利完成首例患者给药，未发生输液反应或其他不良事件。

基石药业-B(02616)：PD-1/VEGF/CTLA-4三特异性抗体CS2009全球多中心I期临床试验顺利完成首例患者给药

头对头帕博利珠单抗，信达生物IBI363（PD-1/IL-2α-bias双特异性抗体融合蛋白）首个关键注册临床研究完成首例受试者给药，用于治疗黑色素瘤

神州细胞抗PD-1单抗联合疗法获批，百利天恒GNC-038 四抗注射液杀入自免领域，强生古塞奇尤单抗在华获批克罗恩病适应症

医药经济报

【首个自研ADC澳洲临床入组康方生物IO 2+ADC战略再进一步】近日，康方生物宣布，公司自主研发的差异化靶向人表皮生长因子受体3（HER3）ADC新药AK138D1，治疗晚期恶性肿瘤的I期临床研究在澳洲完成首例受试者入组。AK138D1是康方生物首个进入临床阶段的ADC药物。ADC药物是康方生物在全球范围内重塑治疗格局，构建肿瘤治疗新标准，以创新疗法造福全球患者的重要力量，也是康方生物推进“IO 2.0+ADC”战略的重要抓手。目前康方生物自主研发的全球首创双抗新药卡度尼利（PD-1/CTLA-4双抗）和依沃西（PD-1/VEGF双抗）均已获批上市。康方生物是全球唯一拥有2个肿瘤免疫治疗双抗的制药公司，在IO+ADC联合战略中已经建立了在肿瘤免疫端的全球领先优势。AK138D1等差异化ADC药物的开发，为康方生物充分挖掘创新产品组合的临床价值，持续迭代肿瘤疗法开拓了更广阔的空间。

【券商聚焦】交银国际维持康方生物(09926)买入评级指PD-1双抗+ADC联用潜力值得期待

瑞昱半导体推出全球首款整合Type-C/PD功能的USB4集线器控制芯片完整通过USB-IF协会认证

阿斯利康(AZN.US)PD-L1+CTLA-4组合在华申报上市一线治疗NSCLC

阿斯利康 PD-L1 新适应症国内申报上市

【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

【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。

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四抗注射液杀入自免领域，强生古塞奇尤单抗在华获批克罗恩病适应症","url":"https://stock-news.laohu8.com/highlight/detail?id=2516580463","media":"医药经济报","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516580463?lang=zh_cn&edition=fundamental","pubTime":"2025-03-01 11:48","pubTimestamp":1740800927,"startTime":"0","endTime":"0","summary":"神州细胞抗PD-1单抗联合疗法获批，一线治疗肝癌2月28日，中国国家药监局官网公示，神州细胞控股子公司神州细胞工程递交的菲诺利单抗注射液与贝伐珠单抗注射液联合疗法的上市许可申请已获得批准。菲诺利单抗为神州细胞自主研发的重组人源化抗PD-1 IgG4型单克隆抗体注射液，首个适应症头颈部鳞状细胞癌已经于2025年2月获NMPA批准上市。这一消息标志着古塞奇尤单抗在克罗恩病适应症上的全球首个批准，为国内克罗恩病患者带来了新的希望。","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=nesSN20250301115219abe18cd0&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, 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康方生物IO 2+ADC战略再进一步】近日，康方生物宣布，公司自主研发的差异化靶向人表皮生长因子受体3（HER3）ADC新药AK138D1，治疗晚期恶性肿瘤的I期临床研究在澳洲完成首例受试者入组。AK138D1是康方生物首个进入临床阶段的ADC药物。ADC药物是康方生物在全球范围内重塑治疗格局，构建肿瘤治疗新标准，以创新疗法造福全球患者的重要力量，也是康方生物推进“IO 2.0+ADC”战略的重要抓手。目前康方生物自主研发的全球首创双抗新药卡度尼利（PD-1/CTLA-4双抗）和依沃西（PD-1/VEGF双抗）均已获批上市。康方生物是全球唯一拥有2个肿瘤免疫治疗双抗的制药公司，在IO+ADC联合战略中已经建立了在肿瘤免疫端的全球领先优势。AK138D1等差异化ADC药物的开发，为康方生物充分挖掘创新产品组合的临床价值，持续迭代肿瘤疗法开拓了更广阔的空间。","url":"https://stock-news.laohu8.com/highlight/detail?id=2514818522","media":"金融界","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514818522?lang=zh_cn&edition=fundamental","pubTime":"2025-02-27 08:40","pubTimestamp":1740616816,"startTime":"0","endTime":"0","summary":"AK138D1是康方生物首个进入临床阶段的ADC药物。ADC药物是康方生物在全球范围内重塑治疗格局，构建肿瘤治疗新标准，以创新疗法造福全球患者的重要力量，也是康方生物推进“IO 2.0+ADC”战略的重要抓手。康方生物是全球唯一拥有2个肿瘤免疫治疗双抗的制药公司，在IO+ADC联合战略中已经建立了在肿瘤免疫端的全球领先优势。AK138D1等差异化ADC药物的开发，为康方生物充分挖掘创新产品组合的临床价值，持续迭代肿瘤疗法开拓了更广阔的空间。","market":"sh","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/2025/02/27084048415964.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":["IE00BPRC5H50.USD","BK1191","ADC","LU1794554557.SGD","BK4080","BK1161","LU0348784397.USD","01477","BK4231","09926","LU0329678170.USD","LU0737861772.HKD","BK4023","PD","BK1209","LU1169590202.USD","IE00B5MMRT66.SGD","LU0329678337.USD","LU1720050803.USD","LU0417516571.SGD","LU1169589451.USD","06078","BK1574","LU2488822045.USD","IE00B543WZ88.USD","BK1583","LU0348783233.USD"],"gpt_icon":0},{"id":"2514021200","title":"【券商聚焦】交银国际维持康方生物(09926)买入评级 指PD-1双抗+ADC联用潜力值得期待","url":"https://stock-news.laohu8.com/highlight/detail?id=2514021200","media":"金吾财讯","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514021200?lang=zh_cn&edition=fundamental","pubTime":"2025-02-26 08:59","pubTimestamp":1740531544,"startTime":"0","endTime":"0","summary":"金吾财讯 | 交银国际研报指，康方生物 依沃西将与辉瑞公司多个ADCs药物开展联合疗法临床试验：2月24日， Summit Therapeutics 宣布与辉瑞达成临床试验合作，共同推进 PD1/VEGF 双抗依沃西与辉瑞多款vedotin ADC 在多种实体瘤中的联合治疗应用。辉瑞将全面负责临床试验的开展及相关费用，Summit将提供依沃西并参与海外研究。初步临床结果显示，PD-1靶向药物能与vedotin ADC形成协同效应。该行维持买入评级和87港元目标价，并继续将公司选为行业重点推荐标的之一。","market":"nz","thumbnail":"https://static.szfiu.com/news/20250109/YmUwNDEzZDkyZTQxMjdjZGQ1ZTFlYjEwODUyNTc4Njg4Nw==.jpg","type":0,"news_type":0,"thumbnails":["https://static.szfiu.com/news/20250109/YmUwNDEzZDkyZTQxMjdjZGQ1ZTFlYjEwODUyNTc4Njg4Nw==.jpg"],"rights":null,"property":["rate"],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"1953886","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":["PD","09926","ADC"],"gpt_icon":0},{"id":"2513711995","title":"瑞昱半导体推出全球首款整合Type-C/PD功能的USB4集线器控制芯片 完整通过USB-IF协会认证","url":"https://stock-news.laohu8.com/highlight/detail?id=2513711995","media":"美通社","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513711995?lang=zh_cn&edition=fundamental","pubTime":"2025-02-24 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一线治疗NSCLC","url":"https://stock-news.laohu8.com/highlight/detail?id=2513606242","media":"智通财经","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513606242?lang=zh_cn&edition=fundamental","pubTime":"2025-02-21 21:24","pubTimestamp":1740144275,"startTime":"0","endTime":"0","summary":"智通财经APP获悉，2月21日，CDE网站显示，阿斯利康(AZN.US)的PD-L1单抗度伐利尤单抗在华申报新适应症。根据阿斯利康2024年财报，此次申报的适应症为联合替西木单抗和标准治疗一线治疗无致敏表皮生长因子受体(EGFR)突变或间变性淋巴瘤激酶(ALK)基因组肿瘤畸变的转移性非小细胞肺癌(NSCLC)成年患者。此次上市申请是基于III期POSEIDON研究的积极结果。该研究在1013例EGFR/ALK野生型转移性NSCLC患者中评估了度伐利尤单抗(1500mg)+替西木单抗(75mg)±标准治疗(铂类化疗)对比标准治疗的疗效和安全性。","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":"http://www.zhitongcaijing.com/content/detail/1253018.html","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":"stock_zhitongcaijing","symbols":["BK4007","LU0320765992.SGD","LU1169589451.USD","LU1829250122.USD","LU2417539215.USD","LU2236285917.USD","PD","BK4585","LU0889565916.HKD","BK4568","LU2462157665.USD","LU1169590202.USD","LU2456880835.USD","BK4588","LU0109394709.USD","BK4023","AZN"],"gpt_icon":0},{"id":"2513266692","title":"阿斯利康 PD-L1 新适应症国内申报上市","url":"https://stock-news.laohu8.com/highlight/detail?id=2513266692","media":"医药时间","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513266692?lang=zh_cn&edition=fundamental","pubTime":"2025-02-21 16:44","pubTimestamp":1740127450,"startTime":"0","endTime":"0","summary":"2月21日，中国国家药监局药品审评中心官网最新公示，阿斯利康在国内递交了度伐利尤单抗注射液的新适应症上市申请，具体适应症暂未披露，本次申报为该药物在国内报上市的的第6项适应症。自2017 年 5 月首次被美国 FDA 批准上市以来，度伐利尤单抗不断扩展新适应症，包括非小细胞肺癌、小细胞肺癌、肝细胞癌、尿路上皮癌和胆道癌等疾病领域。期待度伐利尤单抗更多适应症尽早在国内上市，为广大患者带来治疗新选择。","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=nesSN20250221192248abd77f4e&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, 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15:56","pubTimestamp":1740038163,"startTime":"0","endTime":"0","summary":"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。","market":"sh","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/2025/02/20155648278395.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":["BK1515","09997","BK0042","LU1169590202.USD","BK0239","300685","BK1574","09996","BK1100","159883","IE0005HP3H50.USD","159938","09939","BK1222","PD","BK4023","BK1583","LU2460026573.USD","BK1161","LU1169589451.USD"],"gpt_icon":0},{"id":"2512996836","title":"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","url":"https://stock-news.laohu8.com/highlight/detail?id=2512996836","media":"新浪港股","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512996836?lang=zh_cn&edition=fundamental","pubTime":"2025-02-17 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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","url":"https://stock-news.laohu8.com/highlight/detail?id=2512299829","media":"智通财经","labels":["movement"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512299829?lang=zh_cn&edition=fundamental","pubTime":"2025-02-17 10:57","pubTimestamp":1739761054,"startTime":"0","endTime":"0","summary":"智通财经APP获悉，信达生物涨超4%，截至发稿，涨3.47%，报38.8港元，成交额3.03亿港元。消息面上，2月17日，信达生物宣布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。信达生物制药集团高级副总裁周辉博士表示：\"很高兴在继黑色素瘤后，IBI363再次获得治疗肺鳞癌的FDA快速通道资格认定。","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/1250485.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"movement","news_rank":0,"length":0,"strategy_id":0,"source":"stock_zhitongcaijing","symbols":["BK1589","PD","01801","LU2488822045.USD","LU2328871848.SGD","LU1169590202.USD","BK1583","BK1161","LU1169589451.USD","BK4023","LU1969619763.USD"],"gpt_icon":0},{"id":"2512966214","title":"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","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":["PD","LU1969619763.USD","LU2328871848.SGD","IVBIY","BK1589","BK1583","LU1169589451.USD","BK4023","LU1169590202.USD","BK4139","LU2488822045.USD","01801","BK1161"],"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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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":["02696","03347","LU1169589451.USD","BK4139","PD","BK1161","BK1576","LU1169590202.USD","BK1583","DNA","BK4109","BK4023","BK1141"],"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":"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":"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":["BK1583","LU1169590202.USD","PD","BK0239","BK1161","01877","CDE","BK4017","BK1515","688180","LU1169589451.USD","BK4023"],"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":"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://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":["BK0196","PD","LU1169590202.USD","BK4023","BK0188","BK0238","02696","LU1169589451.USD","BK0187","BK1161","BK0183","BK0012","BK0028","000876"],"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 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