11月17日，泽璟制药跌5.08%，截至发稿，报100.52元/股，成交2.64亿元，换手率0.97%，总市值266.08 亿元。 风险提示：市场有风险，投资需谨慎。本文为AI大模型自动发布，任何在本文出现的信息（包括但不 限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不构成个人投资建 议。 责任编辑：小浪快报 中金新医药A（006981）成立日期2019年5月14日，最新规模8375.56万。今年以来收益27.08%，同类排 名1961/4217；近一年收益21.06%，同类排名2033/3957；成立以来收益66.73%。 中金新医药A（006981）基金经理为丁天宇。 截至发稿，丁天宇累计任职时间4年324天，现任基金资产总规模2.31亿元，任职期间最佳基金回报 12.67%， 任职期间最差基金回报-19.7%。 资料显示，苏州泽璟生物制药股份有限公司位于江苏省昆山市玉山镇晨丰路262号，成立日期2009年3月 18日，上市日期2020年1月23日，公司主营业务涉及化学新药及生物新药的研发、生产及销售。主营业 务收入构成为：药品99.97%，医药中间体及原辅料0.02%，资产租 ...

11月17日，泽璟制药跌5.08%，截至发稿，报100.52元/股，成交2.65亿元，换手率0.97%，总市值266.08 亿元。 资料显示，苏州泽璟生物制药股份有限公司位于江苏省昆山市玉山镇晨丰路262号，成立日期2009年3月 18日，上市日期2020年1月23日，公司主营业务涉及化学新药及生物新药的研发、生产及销售。主营业 务收入构成为：药品99.97%，医药中间体及原辅料0.02%，资产租赁0.00%。 从基金十大重仓股角度 东方阿尔法医疗健康混合发起A（014841）基金经理为孟昱。 截至发稿，孟昱累计任职时间1年355天，现任基金资产总规模3.06亿元，任职期间最佳基金回报 26.56%， 任职期间最差基金回报3.69%。 风险提示：市场有风险，投资需谨慎。本文为AI大模型自动发布，任何在本文出现的信息（包括但不 限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不构成个人投资建 议。 责任编辑：小浪快报 数据显示，东方阿尔法基金旗下1只基金重仓泽璟制药。东方阿尔法医疗健康混合发起A（014841）三 季度减持3.96万股，持有股数5.98万股，占基金净值比例为4.02%，位 ...

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 来自江苏苏州的A股上市公司泽璟制药(688266.SH)发布公告称，为满足公司国际化战略及海外业务布局 需要，提升公司国际品牌知名度，增强公司综合竞争力，公司拟发行境外上市股份（H股）并申请在港 交所主板挂牌上市。 泽璟制药表示，截至目前，公司正与相关中介机构就本次发行上市的相关工作进行商讨，除本次董事会 审议通过的相关议案外，其他关于本次发行上市的具体细节尚未最终确定。 更多香港上市、美国上市等境外IPO资讯可供搜索、查阅，敬请浏览: www.ryanbencapital.com 泽璟制药(688266.SH)于2020年1月23日在上交所上市，截至2025年11月17日午间收市，其总市值约 271.33亿元人民币。 (截图来自雪球) 版权声明：所有瑞恩资本Ryanben Capital的原创文章，转载须联系授权，并在文首/文末注明来源、作 者、微信ID，否则瑞恩将向其追究法律责任。部分文章推送时未能与原作者或公众号平台取得联系。 若涉及版权问题，敬请原作者联系我们。 泽璟制药同时宣布，董事会同意聘请信永中和为公司拟香港发行上市的审计 ...

Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. announced that its injectable ZG006 has received Orphan-drug Designation from the FDA for the treatment of neuroendocrine cancer, which may provide certain policy support for its subsequent development and commercialization in the U.S. [2][5] Group 1: Drug Information - ZG006 (INN name: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody platform, and it has received clinical trial approval from both the FDA and China's NMPA [3]. - ZG006 is the first-in-class molecule targeting DLL3, with potential to become a best-in-class drug, as it connects tumor cells and T cells to enhance tumor cell killing [3]. Group 2: Regulatory and Development Implications - The Orphan-drug Designation allows ZG006 to benefit from various policy supports, including tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity [5]. - The company must still engage with the FDA regarding subsequent clinical trials and registration plans, with the success of these efforts remaining uncertain [2][6]. Group 3: Clinical Research Updates - The company presented clinical research data for ZG006 and ZG005 at the 2025 European Society for Medical Oncology (ESMO) annual meeting, indicating ongoing progress in its clinical development [4].

Core Viewpoint - Zai Jian Pharmaceutical announced that its investigational product ZG006 has received orphan drug designation from the FDA for the treatment of neuroendocrine cancer, marking it as the first trispecific antibody targeting the DLL3 antigen with potential to be a best-in-class molecule [1] Group 1: Product Development - ZG006 is the first trispecific antibody targeting the DLL3 antigen globally [1] - The orphan drug designation will provide ZG006 with policy support for further research, registration, and commercialization in the U.S. [1] Group 2: Benefits of Orphan Drug Designation - The designation includes benefits such as tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity [1]

Core Viewpoint - ZaiJing Pharmaceutical (688266) has received orphan drug designation from the FDA for its investigational product ZG006, intended for the treatment of neuroendocrine cancer, which will facilitate its subsequent research, registration, and commercialization in the U.S. [1] Group 1 - The orphan drug designation provides ZaiJing Pharmaceutical with various policy supports, including tax credits for clinical trial costs [1] - The company will be exempt from new drug application fees as a result of this designation [1] - ZG006 will enjoy seven years of market exclusivity, independent of patent considerations [1]

证券代码：688266 证券简称：泽璟制药 公告编号：2025-052 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZG006 用于治疗神经内分泌癌 获得 FDA 孤儿药资格认定的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 近日，苏州泽璟生物制药股份有限公司（以下简称"公司"）在研产品注射用 ZG006 获得美国食品药品监督管理局（以下简称"FDA"）颁发孤儿药资格认定 （Orphan-drug Designation），用于治疗神经内分泌癌。 本次获得孤儿药资格认定后，公司仍需就注射用ZG006用于治疗神经内分泌 癌的后续临床试验、注册申报方案等与FDA进行沟通与协商，最终能否成功完成 临床试验、获得FDA上市许可及上市时间均具有不确定性。本次获得孤儿药资格 认定事项对公司近期业绩不会产生重大影响，由于药品的研发周期长、审批环节 多、研发投入大，容易受到一些不确定性因素的影响，敬请广大投资者谨慎决策， 注意防范投资风险。 现将具体情况公告如下： 一、药品基本情况 | 药品名称 | 注射用 ...

Core Viewpoint - Zai Jian Pharmaceutical (688266.SH) announced that its investigational product ZG006 injection has received orphan drug designation from the FDA for the treatment of neuroendocrine cancer [1] Group 1: Regulatory Approval - The orphan drug designation allows for potential benefits such as tax credits and market exclusivity, which could enhance the product's commercial viability [1] - The company will need to continue discussions and negotiations with the FDA regarding subsequent clinical trials and registration application plans for ZG006 [1] Group 2: Uncertainties - There remains uncertainty regarding the successful completion of clinical trials, obtaining FDA marketing approval, and the timeline for market entry [1]

Core Points - The company announced that its investigational product ZG006 has received Orphan-drug Designation from the FDA for the treatment of neuroendocrine cancer [1] - ZG006 is a trispecific antibody drug developed through the company's dual/multi-specific antibody research platform [1] - The product has obtained clinical trial approval from both the FDA and China's NMPA, and has been included in breakthrough therapy designations by the respective regulatory authorities [1]

Core Viewpoint - Zai Lab's investigational product ZG006 has received Orphan-drug Designation from the FDA for the treatment of neuroendocrine cancer [1] Group 1 - The product ZG006 is an injectable formulation [1] - The Orphan-drug Designation is a significant regulatory milestone that may facilitate the development and commercialization of ZG006 [1]