Core Viewpoint - The company Zai Lab (688266.SH) has received approval from the National Medical Products Administration for the clinical trial of its drug ZGGS34, which targets MUC17-positive advanced solid tumors [1] Group 1: Drug Development - ZGGS34 is a trispecific antibody drug developed by the company, classified as a trispecific T cell engager (TriTE) [2] - The drug targets CD3, CD28 on T cells, and the tumor-associated antigen (TAA) MUC17, which is highly expressed in various gastrointestinal cancers [2] - ZGGS34 connects tumor cells and T cells, activating T cells to produce perforin, granzyme, and cytokines to kill tumor cells [2] Group 2: Mechanism of Action - The inclusion of a CD28 agonistic antibody in ZGGS34 enhances T cell activation, proliferation, and survival, making it more effective than typical BiTE molecules [2] - CD28 lowers the activation threshold of TCR, enhancing T cell proliferation, metabolism, and anti-apoptotic capabilities [2] Group 3: Preclinical Results - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression in various tumor models, indicating its strong tumor-killing capability [3] - Toxicology studies in non-human primates have demonstrated good safety characteristics for ZGGS34 [3]

Core Viewpoint - Zai Jian Pharmaceutical (688266.SH) has received approval from the National Medical Products Administration for clinical trials of its injection ZGGS34, targeting MUC17 positive advanced solid tumors, indicating a significant advancement in its drug development pipeline [1] Company Summary - The drug ZGGS34 is a trispecific antibody with strong tumor-killing effects and good safety characteristics, highlighting its potential in cancer treatment [1]

Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its drug ZGGS34, targeting MUC17-positive advanced solid tumors [1] Group 1: Drug Development - ZGGS34 is a trispecific antibody drug, classified as a trispecific T cell engager (TriTE), targeting CD3, CD28 on T cells, and the tumor-associated antigen MUC17 [2] - MUC17 is a transmembrane mucin highly expressed in gastric cancer, gastroesophageal junction cancer, pancreatic cancer, and colorectal cancer, making it a popular target for gastrointestinal tumor diagnosis and treatment [2] - ZGGS34 connects tumor cells and T cells, activating T cells to produce perforin, granzyme, and cytokines to kill tumor cells [2] Group 2: Mechanism of Action - The inclusion of a CD28 agonistic antibody in ZGGS34 enhances T cell activation, proliferation, and survival, providing stronger T cell activation capabilities compared to typical BiTE molecules [2] - CD28 binding lowers the T cell receptor activation threshold, enhancing T cell proliferation, metabolism, and anti-apoptotic abilities, thereby improving anti-tumor immune response [2] Group 3: Preclinical Results - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression in various tumor models, indicating its potent tumor-killing effects [3] - Toxicology studies in non-human primates have demonstrated good safety characteristics for ZGGS34 [3]

中国经济网北京9月17日讯泽璟制药(688266.SH)2025年半年度报告显示，2025年上半年，公司实现营业收 入3.76亿元，同比增长56.07%；归属于上市公司股东的净利润-7280.35万元；归属于上市公司股东的扣除 非经常性损益的净利润-1.03亿元；经营活动产生的现金流量净额-1702.03万元。 泽璟制药首次公开发行股票募集资金总额为202,560.00万元，募集资金净额为190,822.08万元。该公司最 终募集资金净额较原计划少47565.92万元。泽璟制药于2020年1月20日发布的招股书显示，其拟募集资金 238,388万元，分别用于新药研发项目、新药研发生产中心二期工程建设项目、营运及发展储备资金。 泽璟制药首次公开发行股票的发行费用(不含税)总额为11,737.92万元，其中中国国际金融股份有限公司、 东吴证券股份有限公司获得保荐和承销费10,328.00万元。 根据泽璟制药于2023年4月25日发布的向特定对象发行股票上市公告书，2023年4月17日，经信永中和会 计师事务所(特殊普通合伙)出具的《苏州泽璟生物制药股份有限公司验资报告》 (XYZH/2023NJAA1B0108) ...

Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received conditional approval from the National Medical Products Administration (NMPA) to conduct pivotal clinical trials for its investigational drug ZG006, with the first subject enrolled in the trial [1][2]. Drug Information - ZG006 (INN: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody research platform, and it has received clinical trial approval from both the U.S. FDA and China's NMPA [1][2]. - ZG006 targets two different DLL3 epitopes and CD3, acting as a T-cell engager to connect T-cells with tumor cells, demonstrating significant tumor suppression in preclinical studies [2]. Clinical Trial Details - The pivotal clinical trial for ZG006 is actively being advanced, with the first subject enrolled recently. The company plans to continue progressing the trial and will apply for conditional marketing approval if the trial results meet expectations [1][2]. Impact on the Company - The initiation of the pivotal clinical trial and the enrollment of the first subject are not expected to have a significant impact on the company's recent performance. The drug must complete clinical trials and receive regulatory approval before it can be marketed [2][3].

Core Viewpoint - Zai Jiang Pharmaceutical has received feedback from the National Medical Products Administration (NMPA) regarding the conditional approval for the clinical trial of its injectable product ZG006, indicating progress in its development [2]. Group 1 - The company has received feedback from the Center for Drug Evaluation (CDE) of the NMPA regarding the conditional approval for the injectable ZG006 [2]. - Based on the current safety and efficacy data of ZG006 and the proposed target population, the CDE has agreed to allow the company to conduct key clinical trials for ZG006 [2]. - The company is actively advancing the key clinical trials for ZG006 in the specified indications and has recently completed the enrollment of the first subject [2].

Core Points - The Medical Health R Index (480016) closed at 8278.77 points, down 0.33%, with a trading volume of 31.765 billion yuan and a turnover rate of 1.08% [1] - Among the index constituents, 18 stocks rose while 31 fell, with Yirui Technology leading the gainers at a 4.4% increase and Zexin Pharmaceutical leading the decliners at a 5.37% decrease [1] Index Constituents Summary - The top ten constituents of the Medical Health R Index include: - WuXi AppTec (sh603259) with a weight of 13.58% and a market cap of 315.96 billion yuan [1] - Hengrui Medicine (sh600276) with a weight of 10.87% and a market cap of 458.96 billion yuan [1] - Mindray Medical (sz300760) with a weight of 8.17% and a market cap of 290.50 billion yuan [1] - United Imaging Healthcare (sh688271) with a weight of 4.14% and a market cap of 126.08 billion yuan [1] - Other notable constituents include Pianzai Shou (sh600436), Yierfu Technology (sz300015), Kelun Pharmaceutical (sz002422), New Hope Liuhe (sz002001), Fosun Pharma (sh600196), and East China Pharmaceutical (sz000963) [1] Capital Flow Analysis - The net outflow of main funds from the index constituents totaled 1.638 billion yuan, while retail investors saw a net inflow of 1.098 billion yuan [1] - Notable capital flows include: - Kailai Ying (002821) with a main fund net inflow of 101 million yuan [2] - Mindray Medical (300760) with a main fund net inflow of approximately 90.77 million yuan [2] - Yuyue Medical (002223) with a main fund net inflow of 24.60 million yuan [2]

Core Viewpoint - ZaiJing Pharmaceutical has received feedback from the National Medical Products Administration (NMPA) regarding the conditional approval for the clinical trial of its investigational drug ZG006, indicating progress in its development [1] Group 1: Product Development - ZG006 is a trispecific antibody drug developed through the company's dual/multi-specific antibody research platform [1] - The drug has received clinical trial approval from both the US FDA and China's NMPA, and has been designated as a breakthrough therapy by the NMPA and granted orphan drug status by the FDA [1] Group 2: Clinical Trials - The NMPA has agreed to allow ZG006 to proceed with critical clinical trials based on current safety and efficacy data and the proposed target population [1] - The company is actively advancing the critical clinical trials for ZG006 and has recently completed the enrollment of the first subject [1]

证券之星消息，9月16日化学制药板块较上一交易日下跌0.57%，泽璟制药领跌。当日上证指数报收于 3861.87，上涨0.04%。深证成指报收于13063.97，上涨0.45%。化学制药板块个股涨跌见下表： 从资金流向上来看，当日化学制药板块主力资金净流出21.39亿元，游资资金净流入7.14亿元，散户资金 净流入14.25亿元。化学制药板块个股资金流向见下表： | 代码 | 名称 | 主力净流入(元) | 主力净占比 游资净流入 (元) | | 游资净占比 散户净流入(元) | | 散户净占比 | | --- | --- | --- | --- | --- | --- | --- | --- | | 688166 博瑞医药 | | 2.01 Z | 18.62% | -363.40万 | -0.34% | -1.98 Z | -18.29% | | 688062 迈威生物 | | 6061.44万 | 10.23% | 2893.67万 | 4.89% | -8955.11万 | -15.12% | | 600624 复日复华 | | 2838.88万 | 10.91% | -904.55万 | -3.48 ...

证券代码：688266 证券简称：泽璟制药 公告编号：2025-038 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZG006 开展关键性临床试验 并完成首例受试者入组的公告 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。 近日，苏州泽璟生物制药股份有限公司（以下简称"公司"）收到国家药品 监督管理局药品审评中心（CDE）关于公司在研产品注射用 ZG006 沟通交流申 请附条件批准上市资格的反馈意见，基于注射用 ZG006 现阶段的安全性、有效 性数据和拟定的目标人群，CDE 同意注射用 ZG006 开展关键性临床试验。公司 正在积极推进注射用 ZG006 在该拟定适应症的关键性临床试验，并于近日完成 首例受试者入组。现将相关情况公告如下： 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 分别被国家药品监督管理局药品审评中心纳入突破性治疗品种，和被美国 FDA 授予孤儿药资格认定 ...