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PagerDuty, Inc.
18.38
+0.1100
0.60%
盤前:
18.51
0.1300
+0.71%
04:47 EDT
成交量:
69.24萬
成交額:
1,264.28萬
市值:
16.74億
市盈率:
-31.05
高:
18.41
開:
18.30
低:
17.85
收:
18.27
資料載入中...
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公司
新聞
公告
【艾德生物:收到醫療器械變更註冊文件】金融界2月20日消息,廈門艾德生物醫藥科技股份有限公司於近日收到國家藥品監督管理局頒發的《醫療器械變更註冊文件》,已完成“PD-L1抗體試劑(免疫組織化學法)”產品原註冊證相關事項的變更。變更內容為預期用途增加相關表述。公司PD-L1抗體試劑已獲批用於非小細胞肺癌、胃癌及胃食管交界處腺癌的伴隨診斷。此次變更顯著增強公司綜合競爭力與市場拓展能力,產品實際銷售情況取決於未來市場推廣效果,尚無法預測對公司未來業績的影響。
金融界
·
02-20
信達生物現漲超3% PD-1/IL-2α-bias雙特異性抗體融合蛋白再獲FDA快速通道資格認定
新浪港股
·
02-17
港股異動 | 信達生物(01801)漲超4% PD-1/IL-2α-bias雙特異性抗體融合蛋白再獲FDA快速通道資格認定
智通财经
·
02-17
信達生物IBI363 (PD-1/IL-2α-bias雙特異性抗體融合蛋白) 再獲美國FDA快速通道資格認定,治療鱗狀非小細胞肺癌
美通社
·
02-17
百時美施貴寶PD-1+LAG-3組合療法一項III期研究失敗
医药魔方Info
·
02-14
神州細胞:控股子公司獲得菲諾利單抗注射液註冊證書
美港电讯
·
02-11
【復宏漢霖(02696.HK):注射用HLX43用於治療復發/轉移性食管鱗癌(ESCC)的 2期臨牀研究於中國境內完成首例患者給藥】復宏漢霖(02696.HK)公佈,近日,一項注射用HLX43(靶向PD-L1 抗體-新型DNA拓撲異構酶I抑制劑偶聯藥物)(HLX43)在復發/轉移性食管鱗癌患者中開展的2期臨牀研究於中國境內(不包括中國港澳台地區,下同)完成首例患者給藥。公司亦計劃於條件具備後開展用於宮頸癌、肝細胞癌、鼻咽癌、頭頸部鱗癌、非小細胞肺癌等潛在適應症治療的相關2期臨牀試驗。
金融界
·
02-10
港股異動 | 君實生物(01877)漲超5% 抗PD-1單抗聯合療法納入CDE突破性治療品種名單
智通财经
·
02-10
復宏漢霖抗PD-1單抗H藥獲歐盟批准,為廣泛期小細胞肺癌患者帶來新希望
金融界
·
02-05
【君實生物:AWT020注射用無菌粉末臨牀試驗申請獲批】君實生物公告,近日,公司收到國家藥品監督管理局覈准簽發的《藥物臨牀試驗批准通知書》,AWT020注射用無菌粉末(項目代號“JS213”)的臨牀試驗申請獲得批准。JS213是PD-1和白細胞介素-2雙功能性抗體融合蛋白,主要用於晚期惡性腫瘤的治療。
金融界
·
02-05
【復星醫藥:控股子公司藥品獲歐盟上市批准】金融界2月5日消息,上海復星醫藥(集團)股份有限公司控股子公司復宏漢霖自主研發的斯魯利單抗注射液聯合卡鉑和依託泊苷適用於廣泛期小細胞肺癌成人患者的一線治療的上市許可申請近日獲歐盟委員會批准。該藥品為本集團自主研發的創新型抗PD-1單抗,在中國境內獲批多個適應症,在歐盟、印度尼西亞、柬埔寨、泰國已獲批上市。截至2024年12月,本集團針對該藥品累計研發投入約為人民幣298,271萬元。2023年,靶向PD-1的單克隆抗體藥品於全球範圍的銷售額約為399億美元。復宏漢霖已授予 Intas Pharmaceuticals Ltd.於許可區域及許可領域獨家商業化該藥品的權利許可。本次獲批將拓展該藥品全球市場區域,提升本集團產品國際影響力。但藥品銷售情況受多種因素影響具有較大不確定性。
金融界
·
02-05
【君實生物:JS213 獲得藥物臨牀試驗批准通知書】金融界2月5日消息,近日,君實生物收到國家藥品監督管理局覈准簽發的《藥物臨牀試驗批准通知書》,AWT020 注射用無菌粉末(項目代號“JS213”)的臨牀試驗申請獲得批准。JS213 是 PD-1 和白細胞介素-2 雙功能性抗體融合蛋白,主要用於晚期惡性腫瘤的治療。截至披露日,國內外尚無同類靶點雙功能性抗體融合蛋白產品獲批上市。JS213 在海外已進入 I 期臨牀試驗階段。藥品研發週期長、環節多且有不確定性因素,敬請投資者謹慎決策,注意防範投資風險。公司將積極推進項目並按規定披露後續進展。
金融界
·
02-05
招銀國際:維持三生製藥(01530)“買入”評級 PD-1/VEGF雙抗早期臨牀數據公佈
智通财经
·
02-03
【奧賽康:子公司在2025年ASCO GI發佈創新藥ASKB589治療一線晚期胃癌研究成果】奧賽康1月24日早間公告,子公司ASKGENELIMITED於2025年1月23日在美國臨牀腫瘤學會胃腸道腫瘤研討會上以壁報形式公佈在研生物創新藥 ASKB589聯合CAPOX及PD-1抑制劑在晚期胃/食管胃交界處腺癌一線治療的最新臨牀研究成果。本項研究中,ASKB589聯合CAPOX以及PD-1抑制劑作為一線治療方案,表現出顯著的腫瘤緩解,且顯示出持續的生存獲益、良好的耐受性,聯合PD-1抑制劑給藥並未觀察到額外的安全性風險。本研究結果支持開展以CLDN18.2中高表達的IV期胃/胃食管交界處腺癌患者為目標人羣的ASKB589三聯療法III期臨牀研究。
金融界
·
01-24
科倫博泰生物-B新藥抗PD-L1塔戈利單抗獲批上市
财中社
·
01-20
科倫博泰生物-B(06990):抗PD-L1塔戈利單抗獲國家藥監局批准上市
智通财经
·
01-20
君實生物:與利奧製藥簽署分銷與商業化協議
美港电讯
·
01-20
【券商聚焦】建銀國際升百濟神州(06160)目標價3.5% 指基本面改善 料PD-1生物藥為銷售帶來正面影響
金吾财讯
·
01-16
建銀國際升百濟神州目標價4%至179港元 今年基本面改善
美港电讯
·
01-16
首款狂犬病雙抗在國內報上市、先聲再明三抗新藥授權艾伯維、默沙東 PD-1 單抗在國內獲批新適應症
医药经济报
·
01-14
更多
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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。IBI363在多种晚期实体瘤中展现出了积极的疗效和安全性信号,目前信达生物正在中国和美国等同时开展IBI363的1/2期临床研究。","market":"other","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://finance.sina.com.cn/stock/hkstock/marketalerts/2025-02-17/doc-inekufee4038451.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":"sina","symbols":["BK4023","01801","LU1169589451.USD","BK1589","LU2328871848.SGD","LU1169590202.USD","LU2488822045.USD","PD","LU1969619763.USD","BK1583","BK1161"],"gpt_icon":0},{"id":"2512299829","title":"港股異動 | 信達生物(01801)漲超4% PD-1/IL-2α-bias雙特異性抗體融合蛋白再獲FDA快速通道資格認定","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_tw&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":["LU1969619763.USD","LU2328871848.SGD","LU1169590202.USD","01801","BK1583","LU1169589451.USD","LU2488822045.USD","BK1589","BK4023","PD","BK1161"],"gpt_icon":0},{"id":"2512966214","title":"信達生物IBI363 (PD-1/IL-2α-bias雙特異性抗體融合蛋白) 再獲美國FDA快速通道資格認定,治療鱗狀非小細胞肺癌","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_tw&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":"百時美施貴寶PD-1+LAG-3組合療法一項III期研究失敗","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_tw&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, .wx-sou","directOrigin":true},"property":[],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250214172812abceb7cb&s=b","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tencent","symbols":["LU1670710661.SGD","IE00BFTCPJ56.SGD","LU1032466523.USD","LU1169590202.USD","LU2242646821.SGD","LU1585245621.USD","III","LU0321505868.SGD","PD","LU0456855351.SGD","LU1430594728.SGD","LU1261432733.SGD","LU1868837300.USD","LU1868836757.USD","LU0225284248.USD","LU0225771236.USD","LU1093756325.SGD","LU1868836914.USD","BMY","BK4023","IE0002141913.USD","LU0096364046.USD","BK4585","LU1718418525.SGD","BK4581","LU0321505439.SGD","LU1169589451.USD","LU1670711040.USD","LU0114720955.EUR","LU0882574055.USD","BK4588","IE00BJJMRZ35.SGD","BK4534","IE00BJT1NW94.SGD","LU2125154778.USD","LU2133065610.SGD","LU1670711123.USD","LU2242652126.USD","LU0985481810.HKD","IE00B2B36J28.USD","LU0306806265.USD","LU1868837136.USD","BK4532","LU0306807586.USD","LU1291159041.SGD","IE00BSNM7G36.USD","LU0061475181.USD","LU1074936037.SGD","LU2125154935.USD","BK4559"],"gpt_icon":0},{"id":"2510187132","title":"神州細胞:控股子公司獲得菲諾利單抗注射液註冊證書","url":"https://stock-news.laohu8.com/highlight/detail?id=2510187132","media":"美港电讯","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2510187132?lang=zh_tw&edition=fundamental","pubTime":"2025-02-11 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","LU1169589451.USD","BK4023","BK0239","PD","688520"],"gpt_icon":0},{"id":"2510310168","title":"【復宏漢霖(02696.HK):注射用HLX43用於治療復發/轉移性食管鱗癌(ESCC)的 2期臨牀研究於中國境內完成首例患者給藥】復宏漢霖(02696.HK)公佈,近日,一項注射用HLX43(靶向PD-L1 抗體-新型DNA拓撲異構酶I抑制劑偶聯藥物)(HLX43)在復發/轉移性食管鱗癌患者中開展的2期臨牀研究於中國境內(不包括中國港澳台地區,下同)完成首例患者給藥。公司亦計劃於條件具備後開展用於宮頸癌、肝細胞癌、鼻咽癌、頭頸部鱗癌、非小細胞肺癌等潛在適應症治療的相關2期臨牀試驗。","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_tw&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":"港股異動 | 君實生物(01877)漲超5% 抗PD-1單抗聯合療法納入CDE突破性治療品種名單","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_tw&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":"復宏漢霖抗PD-1單抗H藥獲歐盟批准,為廣泛期小細胞肺癌患者帶來新希望","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_tw&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":"【君實生物:AWT020注射用無菌粉末臨牀試驗申請獲批】君實生物公告,近日,公司收到國家藥品監督管理局覈准簽發的《藥物臨牀試驗批准通知書》,AWT020注射用無菌粉末(項目代號“JS213”)的臨牀試驗申請獲得批准。JS213是PD-1和白細胞介素-2雙功能性抗體融合蛋白,主要用於晚期惡性腫瘤的治療。","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_tw&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":"【復星醫藥:控股子公司藥品獲歐盟上市批准】金融界2月5日消息,上海復星醫藥(集團)股份有限公司控股子公司復宏漢霖自主研發的斯魯利單抗注射液聯合卡鉑和依託泊苷適用於廣泛期小細胞肺癌成人患者的一線治療的上市許可申請近日獲歐盟委員會批准。該藥品為本集團自主研發的創新型抗PD-1單抗,在中國境內獲批多個適應症,在歐盟、印度尼西亞、柬埔寨、泰國已獲批上市。截至2024年12月,本集團針對該藥品累計研發投入約為人民幣298,271萬元。2023年,靶向PD-1的單克隆抗體藥品於全球範圍的銷售額約為399億美元。復宏漢霖已授予 Intas Pharmaceuticals Ltd.於許可區域及許可領域獨家商業化該藥品的權利許可。本次獲批將拓展該藥品全球市場區域,提升本集團產品國際影響力。但藥品銷售情況受多種因素影響具有較大不確定性。","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_tw&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":"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://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":["BK0012","BK0028","BK1593","BK0239","BK0183","600196","BK1515","BK0187","BK1191","BK0060","02196","BK0196","BK4023","LU1169590202.USD","BK0188","PD","BK1161","BK0096","BK0175","LU1169589451.USD","02696"],"gpt_icon":0},{"id":"2509740583","title":"【君實生物:JS213 獲得藥物臨牀試驗批准通知書】金融界2月5日消息,近日,君實生物收到國家藥品監督管理局覈准簽發的《藥物臨牀試驗批准通知書》,AWT020 注射用無菌粉末(項目代號“JS213”)的臨牀試驗申請獲得批准。JS213 是 PD-1 和白細胞介素-2 雙功能性抗體融合蛋白,主要用於晚期惡性腫瘤的治療。截至披露日,國內外尚無同類靶點雙功能性抗體融合蛋白產品獲批上市。JS213 在海外已進入 I 期臨牀試驗階段。藥品研發週期長、環節多且有不確定性因素,敬請投資者謹慎決策,注意防範投資風險。公司將積極推進項目並按規定披露後續進展。","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_tw&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":"招銀國際:維持三生製藥(01530)“買入”評級 PD-1/VEGF雙抗早期臨牀數據公佈","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_tw&edition=fundamental","pubTime":"2025-02-03 11:41","pubTimestamp":1738554072,"startTime":"0","endTime":"0","summary":"智通财经APP获悉,招银国际发布研报称,维持三生制药“买入”评级,目标价9.91港元,认为公司估值吸引、盈利增长稳健、创新管线具备出海潜力。3级以上TRAE为23.5%,略低于依沃西单抗在III期临床中的29.4%。11月,默沙东引进礼新医药的PD-1/VEGF双抗,总交易金额可达32.88亿美元。多项早期管线进入临床阶段三生制药近期在研发日公布了多项早期临床管线,包括临床I期阶段的706、SSS40和自免领域的626、627等。公司计划在今年2月启动SSS40的II期临床。","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"http://www.zhitongcaijing.com/content/detail/1245312.html","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":"stock_zhitongcaijing","symbols":["PD","01530"],"gpt_icon":0},{"id":"2505893076","title":"【奧賽康:子公司在2025年ASCO GI發佈創新藥ASKB589治療一線晚期胃癌研究成果】奧賽康1月24日早間公告,子公司ASKGENELIMITED於2025年1月23日在美國臨牀腫瘤學會胃腸道腫瘤研討會上以壁報形式公佈在研生物創新藥 ASKB589聯合CAPOX及PD-1抑制劑在晚期胃/食管胃交界處腺癌一線治療的最新臨牀研究成果。本項研究中,ASKB589聯合CAPOX以及PD-1抑制劑作為一線治療方案,表現出顯著的腫瘤緩解,且顯示出持續的生存獲益、良好的耐受性,聯合PD-1抑制劑給藥並未觀察到額外的安全性風險。本研究結果支持開展以CLDN18.2中高表達的IV期胃/胃食管交界處腺癌患者為目標人羣的ASKB589三聯療法III期臨牀研究。","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_tw&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 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。","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://24h.jrj.com.cn/2025/01/24081447771538.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":["BK0028","06978","LU1169590202.USD","002755","LU1169589451.USD","BK1574","III","BK4134","BK0239","PD","BK1161","159992","BK4023"],"gpt_icon":0},{"id":"2504040445","title":"科倫博泰生物-B新藥抗PD-L1塔戈利單抗獲批上市","url":"https://stock-news.laohu8.com/highlight/detail?id=2504040445","media":"财中社","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2504040445?lang=zh_tw&edition=fundamental","pubTime":"2025-01-20 20:21","pubTimestamp":1737375681,"startTime":"0","endTime":"0","summary":"财中社1月20日电科伦博泰生物-B(06990)发布公告,公司的抗PD-L1单抗塔戈利单抗(前称KL-A167)已获得中国国家药品监督管理局批准上市。该药物用于一线治疗复发或转移性鼻咽癌患者,联合顺铂和吉西他滨的治疗方案在有效性和安全性方面表现优异。","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://finance.eastmoney.com/a/202501203302386677.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_eastmoney","symbols":["PD","LU1169589451.USD","LU1169590202.USD","BK4023","BK1161","LU0196878994.USD","06990"],"gpt_icon":0},{"id":"2504401512","title":"科倫博泰生物-B(06990):抗PD-L1塔戈利單抗獲國家藥監局批准上市","url":"https://stock-news.laohu8.com/highlight/detail?id=2504401512","media":"智通财经","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2504401512?lang=zh_tw&edition=fundamental","pubTime":"2025-01-20 20:09","pubTimestamp":1737374944,"startTime":"0","endTime":"0","summary":"智通财经APP讯,科伦博泰生物-B 发布公告,公司联合顺铂和吉西他滨用于一线治疗复发或转移性鼻咽癌患者的靶向程序性细胞死亡配体1的创新人源化单克隆抗体塔戈利单抗(科泰莱)已获中国国家药品监督管理局批准于中国上市。本次获批主要基于一项评价塔戈利单抗联合顺铂和吉西他滨对照安慰剂联合顺铂和吉西他滨治疗复发或转移性鼻咽癌的有效性和安全性的随机、双盲、安慰剂对照、多中心III期临床研究。","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/1240635.html","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":"stock_zhitongcaijing","symbols":["LU1169590202.USD","06990","BK4023","LU0196878994.USD","PD","LU1169589451.USD","BK1161"],"gpt_icon":0},{"id":"2504704844","title":"君實生物:與利奧製藥簽署分銷與商業化協議","url":"https://stock-news.laohu8.com/highlight/detail?id=2504704844","media":"美港电讯","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2504704844?lang=zh_tw&edition=fundamental","pubTime":"2025-01-20 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11:02","pubTimestamp":1736996570,"startTime":"0","endTime":"0","summary":"金吾财讯 | 建银国际发研报指,百济神州 宣布2025财年有望首次实现美国通用会计准则下的运营利润。考虑到百济神州运营效率的提升,该行将2025财年和2026财年的运营费用与销售额比率预测分别下调12%和3%,降至82%和78%。该行指,集团2025年基本面改善,推动估值上升,考虑到集团已在美国获准的PD-1生物药将为未来销售带来正面影响,将目标价从173港元上调3.5%至179港元,维持“跑赢大市”评级。","market":"other","thumbnail":"https://static.szfiu.com/news/20250109/MTU3MGM5Y2M3ZDk5Mjg2ODIwNjM2NDU0OA==.jpg","type":0,"news_type":0,"thumbnails":["https://static.szfiu.com/news/20250109/MTU3MGM5Y2M3ZDk5Mjg2ODIwNjM2NDU0OA==.jpg"],"rights":null,"property":["rate"],"language":"zh","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"1951563","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","159839","ONC","688235","06160"],"gpt_icon":0},{"id":"2503913981","title":"建銀國際升百濟神州目標價4%至179港元 今年基本面改善","url":"https://stock-news.laohu8.com/highlight/detail?id=2503913981","media":"美港电讯","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2503913981?lang=zh_tw&edition=fundamental","pubTime":"2025-01-16 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