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 ...

Core Viewpoint - Zai Lab (688266.SH) has received feedback from the Center for Drug Evaluation (CDE) regarding its investigational product, injectable ZG006, which has been granted conditional approval to initiate key clinical trials based on current safety and efficacy data [1] Group 1 - The CDE has agreed to allow Zai Lab to conduct critical clinical trials for injectable ZG006 based on the proposed target population [1] - The company is actively advancing the key clinical trials for injectable ZG006 in the designated indications and has recently completed the enrollment of the first subject [1]

Core Viewpoint - Zai Lab (688266) has received feedback from the National Medical Products Administration (NMPA) regarding the conditional approval for the clinical trial of its investigational product, ZG006 injection, indicating progress in its development for advanced small cell lung cancer patients [1] Group 1 - The NMPA's Center for Drug Evaluation (CDE) has agreed to allow ZG006 to proceed with critical clinical trials based on current safety and efficacy data [1] - ZG006 has been included in the CDE's list of breakthrough therapies, targeting patients with advanced small cell lung cancer who have previously undergone platinum-based chemotherapy and at least one other systemic treatment [1] - The company has successfully completed the enrollment of the first subject in the critical clinical trial for ZG006 [1]

9月16日，泽璟制药跌5.02%，截至发稿，报104.46元/股，成交2.50亿元，换手率0.89%，总市值276.51 亿元。泽璟制药股价已经连续6天下跌，区间累计跌幅8.99%。 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%。 华西研究精选混合发起（020444）成立日期2023年12月28日，最新规模1.17亿。今年以来收益26.04%， 同类排名3264/8174；近一年收益61.69%，同类排名2107/7982；成立以来收益21.67%。 华西研究精选混合发起（020444）基金经理为吴文庆。 截至发稿，吴文庆累计任职时间11年268天，现任基金资产总规模1.17亿元，任职期间最佳基金回报 102.89%， 任职期间最差基金回报-21.1%。 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 ...

证券日报网讯 9月15日晚间，泽璟制药发布公告称，本次保荐代表人变更后，公司的持续督导保荐代表 人为周凌轩先生、赵冀先生，持续督导期截至2025年12月31日。 （文章来源：证券日报） ...

证券代码：688266 证券简称：泽璟制药 公告编号：2025-037 中金公司作为公司首次公开发行股票并在科创板上市、向特定对象发行股票 的保荐机构、主承销商和持续督导机构，原委派高广伟先生、赵冀先生担任公司 持续督导保荐代表人。现因原保荐代表人高广伟先生工作变动，无法继续负责公 司的持续督导保荐工作，为保证公司持续督导工作有序进行，中金公司决定委派 周凌轩先生接替高广伟先生担任公司的持续督导保荐代表人，继续履行保荐职 责。 本次保荐代表人变更后，公司的持续督导保荐代表人为周凌轩先生（简历详 见附件）、赵冀先生，持续督导期截至 2025 年 12 月 31 日。 公司董事会对高广伟先生在担任公司持续督导保荐代表人期间所做的工作 表示衷心的感谢！ 特此公告。 苏州泽璟生物制药股份有限公司董事会 苏州泽璟生物制药股份有限公司 关于变更持续督导保荐代表人的公告 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。 苏州泽璟生物制药股份有限公司（以下简称"公司"或"泽璟制药"）于近 日收到中国国际金融股份有限公司（以下简称"中金公司" ...