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药捷安康-B:替恩戈替尼片新药上市申请获国家药品监督管理局受理
Mei Ri Jing Ji Xin Wen· 2025-12-19 00:45
每经AI快讯,12月19日,药捷安康-B(02617.HK)发布公告,替恩戈替尼片的新药上市申请已获中国国家 药品监督管理局药品审评中心受理,拟用于治疗既往至少接受过一种系统性治疗和FGFR抑制剂治疗的 晚期、转移性或不可手术切除的胆管癌成人患者。此前,替恩戈替尼片此适应症已获批准纳入优先审评 品种名单及突破性治疗品种名单。 (文章来源:每日经济新闻) ...
药捷安康-B(02617):替恩戈替尼片新药上市申请获国家药品监督管理局受理
智通财经网· 2025-12-19 00:29
智通财经APP讯,药捷安康-B(02617)发布公告,替恩戈替尼片的新药上市申请已获中国国家药品监督管 理局药品审评中心受理,拟用于治疗既往至少接受过一种系统性治疗和FGFR抑制剂治疗的晚期、转移 性或不可手术切除的胆管癌成人患者。此前,替恩戈替尼片此适应症已获批准纳入优先审评品种名单及 突破性治疗品种名单。 ...
药捷安康-B:替恩戈替尼片新药上市申请获国家药品监督管理局受理
Zhi Tong Cai Jing· 2025-12-19 00:25
药捷安康-B(02617)发布公告,替恩戈替尼片的新药上市申请已获中国国家药品监督管理局药品审评中 心受理,拟用于治疗既往至少接受过一种系统性治疗和FGFR抑制剂治疗的晚期、转移性或不可手术切 除的胆管癌成人患者。此前,替恩戈替尼片此适应症已获批准纳入优先审评品种名单及突破性治疗品种 名单。 ...
药捷安康-B(02617) - 自愿性公告替恩戈替尼片新药上市申请获国家药品监督管理局受理
2025-12-19 00:11
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 本公司董事會(「董事會」)欣然宣佈,替恩戈替尼片的新藥上市申請已獲中國國家 藥品監督管理局(「NMPA」)藥品審評中心(「CDE」)受理,擬用於治療既往至少 接受過一種系統性治療和FGFR抑制劑治療的晚期、轉移性或不可手術切除的膽 管癌成人患者。此前,替恩戈替尼片此適應症已獲批准納入優先審評品種名單及 突破性治療品種名單。 上市規則第18A.08(3)條規定的警示聲明:無法保證本公司將能最終成功開發及銷 售相關產品。 承董事會命 藥捷安康(南京)科技股份有限公司 董事長兼首席執行官 吳永謙博士 TransThera Sciences (Nanjing), Inc. 藥捷安康(南京)科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2617) 自願性公告 替恩戈替尼片新藥上市申請獲國家藥品監督管理局受理 本公告由藥捷安康(南京)科技股份有限公司(「本公司」,連同其附屬公司統稱「本 ...
异动盘点1218 |卓悦控股股价实现翻倍,航空股延续增长趋势;Andersen Group,Medline大涨超40%
贝塔投资智库· 2025-12-18 04:04
点击蓝字,关注我们 7 . 首都机场(00694)逆市涨超6.7% 。消息面上,上海浦东、虹桥机场及北京首都机场陆续启动新一轮 免税招标,关键变化是引入外资参与者。 8 . 浙江世宝(01057)再涨超4.1% 。消息面上,工业和信息化部公布我国首批L3级有条件自动驾驶车型 准入许可,两款分别适配城市拥堵、高速路段的车型将在北京、重庆两地指定区域开展试点。 9 . 长飞光纤光缆(06869)昨日大涨超21%,公司A股2连板。截至发稿,涨2.28% 。消息面上,近日市 场热议光纤涨价。据看财经消息,有机构认为AI驱动光纤涨价。此前市场普遍认为,受限于运营商宽 带投资放缓,光纤始终处于降价周期。 10 . 药捷安康-B(02617)微跌0.23% 。消息面上,药捷安康-B此前发布公告,替恩戈替尼片已获中国国 家药品监督管理局(NMPA)药品审评中心(CDE)批准纳入优先审评品种名单,拟定适应症为:用于既往 今日上午港股 1 . 卓悦控股(00653)再涨超11%,近五个交易日股价实现翻倍。截至发稿,涨9.48% 。消息面上,卓悦 控股近期发布公告,附属卓悦供应链与紫元元(08223)订立不具法律约束力的谅解备忘录 ...
港股异动 药捷安康-B(02617)早盘涨超9% 此前替恩戈替尼片获国家药监局批准纳入优先审评品种名单
Jin Rong Jie· 2025-12-18 03:05
智通财经获悉,药捷安康-B(02617)早盘涨超9%,截至发稿,涨4.9%,报179.7港元,成交额7796.4万港 元。 本文源自:智通财经网 消息面上,药捷安康-B此前发布公告,替恩戈替尼片已获中国国家药品监督管理局(NMPA)药品审评中 心(CDE)批准纳入优先审评品种名单,拟定适应症为:用于既往至少接受过一种系统性治疗和FGFR抑 制剂治疗的晚期、转移性或不可手术切除的胆管癌成人患者的治疗。此前,替恩戈替尼已获NMPA授予 治疗胆管癌的突破性治疗品种认定。 此外,近日,药捷安康-B宣布,公司核心产品替恩戈替尼在美国开展的针对胆管癌的探索性临床2期结 果在《柳叶刀,胃肠病和肝病学》(影响因子 38.6)上发表。在这项2期、开放标签、多中心研究 (NCT04919642)中,符合条件的胆管癌患者包括携带FGFR2融合且对FGFR抑制剂存在原发性或获得性 耐药的患者,或存在其他FGFR基因改变的患者,以及FGFR野生型患者。替恩戈替尼可克服FGFR2融 合阳性胆管癌患者对FGFR抑制剂的获得性耐药,并在其他FGFR基因改变的胆管癌患者中显示出抗肿 瘤活性。 ...
药捷安康-B早盘涨超9% 此前替恩戈替尼片获国家药监局批准纳入优先审评品种名单
Zhi Tong Cai Jing· 2025-12-18 02:00
药捷安康-B(02617)早盘涨超9%,截至发稿,涨4.9%,报179.7港元,成交额7796.4万港元。 消息面上,药捷安康-B此前发布公告,替恩戈替尼片已获中国国家药品监督管理局(NMPA)药品审评中 心(CDE)批准纳入优先审评品种名单,拟定适应症为:用于既往至少接受过一种系统性治疗和FGFR抑 制剂治疗的晚期、转移性或不可手术切除的胆管癌成人患者的治疗。此前,替恩戈替尼已获NMPA授予 治疗胆管癌的突破性治疗品种认定。 此外,近日,药捷安康-B宣布,公司核心产品替恩戈替尼在美国开展的针对胆管癌的探索性临床2期结 果在《柳叶刀,胃肠病和肝病学》(影响因子38.6)上发表。在这项2期、开放标签、多中心研究 (NCT04919642)中,符合条件的胆管癌患者包括携带FGFR2融合且对FGFR抑制剂存在原发性或获得性 耐药的患者,或存在其他FGFR基因改变的患者,以及FGFR野生型患者。替恩戈替尼可克服FGFR2融 合阳性胆管癌患者对FGFR抑制剂的获得性耐药,并在其他FGFR基因改变的胆管癌患者中显示出抗肿 瘤活性。 ...
港股异动 | 药捷安康-B(02617)早盘涨超9% 此前替恩戈替尼片获国家药监局批准纳入优先审评品种名单
智通财经网· 2025-12-18 01:52
智通财经APP获悉,药捷安康-B(02617)早盘涨超9%,截至发稿,涨4.9%,报179.7港元,成交额7796.4 万港元。 此外,近日,药捷安康-B宣布,公司核心产品替恩戈替尼在美国开展的针对胆管癌的探索性临床2期结 果在《柳叶刀,胃肠病和肝病学》(影响因子 38.6)上发表。在这项2期、开放标签、多中心研究 (NCT04919642)中,符合条件的胆管癌患者包括携带FGFR2融合且对FGFR抑制剂存在原发性或获得性 耐药的患者,或存在其他FGFR基因改变的患者,以及FGFR野生型患者。替恩戈替尼可克服FGFR2融 合阳性胆管癌患者对FGFR抑制剂的获得性耐药,并在其他FGFR基因改变的胆管癌患者中显示出抗肿 瘤活性。 消息面上,药捷安康-B此前发布公告,替恩戈替尼片已获中国国家药品监督管理局(NMPA)药品审评中 心(CDE)批准纳入优先审评品种名单,拟定适应症为:用于既往至少接受过一种系统性治疗和FGFR抑 制剂治疗的晚期、转移性或不可手术切除的胆管癌成人患者的治疗。此前,替恩戈替尼已获NMPA授予 治疗胆管癌的突破性治疗品种认定。 ...
港股开盘:恒指涨0.17%、科指涨0.21%,创新药及有色金属概念股走高,内房股表现活跃
Jin Rong Jie· 2025-12-04 01:37
Market Overview - US stock market continues to rise with increasing expectations of interest rate cuts, leading to a slight opening increase in Hong Kong stocks, with the Hang Seng Index up 0.17% at 25,804.01 points [1] - Major technology stocks mostly rose, with Alibaba down 0.33%, Tencent down 0.16%, JD.com up 0.61%, Xiaomi up 0.3%, NetEase up 0.32%, Meituan up 0.94%, and Kuaishou up 0.07% [1] - The innovative drug concept opened high, with Gilead Sciences up over 3% and BeiGene up 3.1% [1] - Real estate stocks were active, with China Oceanwide Holdings up over 1% [1] - The non-ferrous metals sector performed actively, with Chalco International up 7.17% and Luoyang Molybdenum up 3.43% [1] - Airline stocks opened lower, with China Eastern Airlines down over 1% [1] - Robotics concept stocks opened high, with Sanhua Intelligent Control up 5.67% and Yujian up 4.06% [1] Company News - InnoCare Pharma (02577.HK) has reached a strategic cooperation agreement with ON Semiconductor to accelerate the development of the GaN industry ecosystem [2] - The collaboration aims to integrate InnoCare's advanced GaN manufacturing capabilities with ON Semiconductor's expertise in system packaging and integration, potentially generating hundreds of millions in GaN sales over the next few years [2] - Agile Group (03383.HK) reported a total pre-sale amount of approximately 8.08 billion, a year-on-year decrease of 45.2% [3] - Jingrui Holdings (01862.HK) reported a cumulative contract sales amount of approximately 876 million, a year-on-year decrease of 54.1% [4] - China Aluminum International (02068.HK) announced that its subsidiary won a bid for a new 394,000 tons/year electrolytic aluminum project in Shanxi, with a total contract price of 3.03 billion [4] - Stone Pharmaceutical Group (01093.HK) received clinical trial approval for a selective 5-HT2A receptor agonist in the US [5] - Fosun Pharma (02196.HK) received clinical trial approval for its subsidiary's FXS887 tablets [6] - Zai Lab (02617) had its Tislelizumab tablets included in the priority review list by the National Medical Products Administration [7] - Deking Pharma (06996) received approval in Hong Kong for its Hivio® to treat two new indications: multiple myeloma and diffuse large B-cell lymphoma [7] - Kaisa Group (01813) has postponed its liquidation hearing to December 8 [8] Industry Insights - According to CCB International, domestic demand policies are being promoted, and the market is focusing on the "New Year" expectations [9] - After the consolidation in November, the Hong Kong stock market is expected to welcome a layout window for the year-end rally in December [9] - The focus is shifting from external environments to internal policies, with attention on the Central Economic Work Conference scheduled for mid-December [9] - Tianfeng Securities reported that most northern provinces have begun implementing staggered production during the heating season, with over 85% of clinker lines in a shutdown state [9] - The overall staggered production efforts have strengthened, with Hunan planning a month-long shutdown in December due to environmental pressures [9] - The bottom profitability support for cement is strong in the short term, with head enterprises starting to address overproduction capacity indicators [9]
港股公告掘金 | 英诺赛科与安森美半导体达成共同加速推进氮化镓产业生态建设的战略合作协议
Zhi Tong Cai Jing· 2025-12-03 15:22
Group 1: Company Announcements - JD Industrial (07618) plans to globally issue 211 million shares, with an expected listing date of December 11 [1] - China Gas (00384) adheres to its "green city operator" strategy, building a multi-energy complementary energy system and ecological collaboration, signing a strategic cooperation agreement with EVE Energy [1] - China Nuclear International (02302) indirectly controlled parent company China Uranium Industry officially listed on the Shenzhen Stock Exchange, highlighting its enhanced capital market position [1] - Innoscience (02577) and ON Semiconductor have reached a strategic cooperation agreement to accelerate the development of the gallium nitride industry ecosystem [1] - Innoscience (02577) won a lawsuit against Infineon, with the ITC ruling that the two involved patents were not infringed [1] - Wangshan Wangshui-B (02630) and Ascletis Pharma (02096) signed a licensing agreement for the new indication of VV116 [1] - China Biopharmaceutical (01177) received approval for the launch of the Rotigotine patch [1] - Dechra Pharmaceuticals-B (06996) received approval in Hong Kong for the use of Hivio® in treating multiple myeloma and diffuse large B-cell lymphoma [1] - Xianruida Medical-B (06669) received approval from the National Medical Products Administration for the registration application of the microcatheter V-otter [1] - Jiajie Ankang-B (02617) had its Tiengogatin tablets approved for inclusion in the priority review list by the National Medical Products Administration [1] - Yuexiu Transportation Infrastructure (01052) plans to acquire 85% equity of Shandong Qinbin Expressway for 1.1535 billion yuan [1] Group 2: Share Buybacks and Holdings - Tencent Holdings (00700) repurchased 1.04 million shares for 636 million HKD on December 3 [2] - Xiaomi Group-W (01810) spent approximately 302 million HKD to repurchase 7.5 million shares on December 3 [2] - Midea Group (00300) repurchased 121.27 million A-shares for 99.9984 million yuan on December 3 [2] - SF Express (06936) repurchased 163.86 million A-shares for 62.1907 million yuan on December 3 [2] - COSCO Shipping Holdings (01919) repurchased 3 million shares for 41.3725 million HKD on December 3 [2] - China Feihe (06186) repurchased 400,000 shares for 16.7927 million HKD on December 3 [2] - Galen Pharmaceuticals-B (01672) repurchased 130.6 million shares for 15.9275 million HKD on December 3 [2] - Fenbi (02469) repurchased 453.05 million shares for 14.359 million HKD on December 3 [2] - Jieli Trading Treasure (08017) saw Chairman and Executive Director Liu Yong increase holdings by 1 million shares [2] - Yiming Anke-B (01541) had Executive Director Tian Wenzhi increase holdings by 50,000 H-shares [2] - Dongfang Electric (01072) announced that Senior Vice President Wang Jun plans to reduce holdings by no more than 6,250 shares [2] - Red Star Macalline (01528) shareholder Hangzhou Haoyue plans to reduce holdings by no more than approximately 131 million shares [2] Group 3: Operating Performance - Agile Group (03383) reported a total pre-sale amount of approximately 8.08 billion yuan in the first 11 months, a year-on-year decrease of 45.2% [2]