证券代码：688266 证券简称：泽璟制药 公告编号：2025-043 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZG006 与依托泊苷及顺铂联用 获得药物临床试验批准通知书的公告 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： 苏州泽璟生物制药股份有限公司（以下简称"公司"）于近日收到国家药品监 督管理局（以下简称"国家药监局"）核准签发的《药物临床试验批准通知书》， 注射用 ZG006 与依托泊苷及顺铂联合用于晚期神经内分泌癌的临床试验获得批 准。 本次临床试验获批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。 现将相关情况公告如下： 苏州泽璟生物制药股份有限公司董事会 一、药品基本情况 二、药品相关情况 ZG006（INN 名：alveltamig）是公司通过其双/多特异性抗体研发平台开发 的一个三特异性抗体药物，已获得美国 FDA 和中国 NMPA 临床试验许可，并已 分别被国家 ...

Core Viewpoint - Zai Lab has received approval from the National Medical Products Administration for clinical trials of ZG006 in combination with etoposide and cisplatin for advanced neuroendocrine carcinoma, marking a significant milestone for the company's innovative drug development [1][2]. Group 1: Drug Development - ZG006 (INN: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody platform, which has received clinical trial approvals from both the FDA and NMPA [1]. - ZG006 has been designated as a breakthrough therapy by the NMPA and has received orphan drug designation from the FDA, highlighting its potential in treating rare diseases [1]. - ZG006 is the first-in-class molecule targeting DLL3, with the potential to become a best-in-class therapy due to its unique mechanism of action [1]. Group 2: Mechanism of Action - ZG006 binds to different DLL3 epitopes on tumor cells and the CD3 region on T cells, effectively bridging the two and enhancing T cell-mediated tumor cell destruction [2]. - Preclinical studies have demonstrated significant tumor suppression in mouse models, with a notable proportion of tumors completely regressing, indicating ZG006's strong anti-tumor efficacy [2].

Core Viewpoint - Zai Lab has received approval from the National Medical Products Administration for clinical trials of ZG006 in combination with etoposide and cisplatin for advanced neuroendocrine carcinoma, marking a significant milestone for the company's innovative drug development [1][2]. Group 1: Drug Development - ZG006 (INN: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody platform, which has received clinical trial approvals from both the FDA and NMPA [1]. - ZG006 has been designated as a breakthrough therapy by the NMPA and has received orphan drug designation from the FDA, highlighting its potential in treating rare diseases [1]. - ZG006 is the world's first trispecific antibody targeting DLL3, with the potential to become a best-in-class molecule in its category [1]. Group 2: Mechanism of Action - ZG006 binds to different DLL3 epitopes on tumor cells and connects to T cells, effectively bringing T cells closer to tumor cells to enhance the specific killing of tumor cells [2]. - Preclinical studies have shown that ZG006 exhibits significant tumor suppression in mouse models, leading to a notable proportion of complete tumor regression, indicating its strong tumor-killing efficacy [2].

Core Viewpoint - Zai Lab (688266.SH) has received approval from the National Medical Products Administration for a clinical trial of its injectable ZG006 in combination with Etoposide and Cisplatin for advanced neuroendocrine carcinoma [1] Group 1 - The clinical trial approval indicates progress in Zai Lab's oncology pipeline, particularly for treatments targeting advanced neuroendocrine cancers [1] - ZG006 is positioned to potentially enhance treatment options in a challenging cancer segment, reflecting the company's commitment to oncology research [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for a clinical trial of ZG006 in combination with Etoposide and Cisplatin for advanced neuroendocrine carcinoma [1] Group 1: Company Information - The drug ZG006 is specified for injection and has a dosage of 5mg per vial [1] - The applicants for the clinical trial approval include Suzhou Zelgen Biopharmaceutical Co., Ltd. and Shanghai Zelgen Pharmaceutical Technology Co., Ltd. [1] Group 2: Clinical Trial Approval - The approval allows the company to conduct a clinical trial using ZG006 in conjunction with Etoposide and Cisplatin for patients with advanced neuroendocrine carcinoma [1] - The approval is noted to have no significant impact on the company's recent performance [1] Group 3: Research and Development Considerations - The drug development process is characterized by a long timeline, multiple approval stages, and substantial research investment, which introduces uncertainty [1]

11月13日，泽璟制药涨5.13%，截至发稿，报106.15元/股，成交3.00亿元，换手率1.10%，总市值280.99 亿元。 截至发稿，李明蔚累计任职时间2年266天，现任基金资产总规模1.59亿元，任职期间最佳基金回 报-8.38%， 任职期间最差基金回报-8.38%。 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。 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%。 责任编辑：小浪快报 中银证券健康产业混合（002938）成立日期2016年9月7日，最新规模1.59亿。今年以来收益38.97%，同 类排名1858/8145；近一年收益21.19%，同类排名3334/8059；成立以来收益133.42%。 中银证券健康产业混合（0029 ...

截至发稿，朱明睿累计任职时间3年134天，现任基金资产总规模7907.3万元，任职期间最佳基金回报 25.32%， 任职期间最差基金回报-10.61%。 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。 数据显示，诺德基金旗下1只基金重仓泽璟制药。诺德中小盘混合（570006）三季度持有股数1.6万股， 占基金净值比例为4.98%，位居第八大重仓股。根据测算，今日浮盈赚取约8.29万元。 诺德中小盘混合（570006）成立日期2010年6月28日，最新规模3628.58万。今年以来收益35.29%，同类 排名2236/8145；近一年收益20.64%，同类排名3426/8059；成立以来收益65.44%。 诺德中小盘混合（570006）基金经理为朱明睿。 11月13日，泽璟制药涨5.13%，截至发稿，报106.15元/股，成交2.98亿元，换手率1.09%，总市值280.99 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200 ...

Group 1 - The immunotherapy sector is experiencing a strong rebound, with companies like Zhongyuan Qihuo and Kaineng Health hitting the daily limit up [1] - Other companies in the sector, such as Jimin Health, Guanhao Bio, Chengda Pharmaceutical, Zexing Pharmaceutical, and Heyuan Bio, are also showing significant gains [1]

Core Insights - A-shares core assets showed strong performance, leading the Shanghai Composite Index to turn positive in early trading on November 12 [1] - Key sectors such as oil and gas extraction, insurance, banking, medical devices, and innovative pharmaceuticals saw significant gains [1] Market Performance - The CSI A500 Index experienced fluctuations in early trading, with the A500 ETF from E Fund (159361) recording a trading volume exceeding 1.7 billion yuan within the first hour, indicating increased activity compared to the previous day [1] - Leading stocks included Enjie Co., Ltd., XW Communications, and China Aluminum, contributing to the index's performance [1] Sector Analysis - The innovative pharmaceutical ETF from E Fund (516080) also saw a rise of over 1.7% in early trading, driven by strong performances from stocks like Baillie Tianheng, Zai Lab, and BeiGene [1] - Despite market adjustments, the Shanghai Composite Index remained above 4000 points, suggesting that the adjustments are within a healthy range [1] Investment Strategy - Analysts suggest that the frequent switching of market styles has increased operational difficulty for investors, recommending a focus on the A500 Index for a balanced investment approach [1] - The CSI A500 Index consists of 500 stocks with large market capitalization and good liquidity, optimizing industry balance and covering most of the CSI's tertiary industries [1] Cost Efficiency - The management fee for the A500 ETF from E Fund (159361) is only 0.15% per year, providing a low-cost option for investors to gain exposure to core A-share assets [1]

Core Viewpoint - Zai Jian Pharmaceutical has shown a significant stock price increase of 59.32% year-to-date, despite recent fluctuations in trading performance [1][2] Company Overview - Zai Jian Pharmaceutical, established on March 18, 2009, and listed on January 23, 2020, is located in Kunshan, Jiangsu Province, and focuses on the research, production, and sales of chemical and biological new drugs [1][2] - The company's main revenue source is pharmaceuticals, accounting for 99.97% of total revenue, with minimal contributions from intermediates and asset leasing [1] Financial Performance - For the period from January to September 2025, Zai Jian Pharmaceutical reported a revenue of 593 million yuan, representing a year-on-year growth of 54.49% [2] - The company recorded a net profit attributable to shareholders of -93.42 million yuan, showing a year-on-year increase of 4.58% [2] Stock Market Activity - As of November 12, Zai Jian Pharmaceutical's stock price was 99.27 yuan per share, with a market capitalization of 26.278 billion yuan [1] - The stock has experienced a trading volume of 50.129 million yuan, with a turnover rate of 0.19% [1] - The stock has appeared on the "Dragon and Tiger List" once this year, with a net buy of 187 million yuan on October 31 [1] Shareholder Information - As of September 30, 2025, the number of shareholders increased to 8,809, with an average of 30,049 circulating shares per person [2] - Notable institutional shareholders include China Europe Medical Health Mixed A and Industrial Bank Frontier Medical Stock A, with varying changes in their holdings [2]