Core Viewpoint - Fudan Zhangjiang (688505.SH) has received approval from the National Medical Products Administration for the clinical trial application of FZ-P001 sodium for intraoperative visualization of malignant lesions in known or suspected lung cancer patients [1] Group 1: Product Development - FZ-P001 sodium is a first-class new chemical compound independently developed by the company, characterized as an innovative photosensitizer [1] - The active ingredient is a molecule formed by the conjugation of a folate receptor-targeting small molecule and a phthalocyanine photosensitizer, which can target malignant tumor tissues with high expression of folate receptor alpha (FRα) and fluoresce in the near-infrared range [1] Group 2: Clinical Application - The company plans to utilize this drug to develop intraoperative fluorescence guidance technology, indicating the residual malignant tumor tissue and margin status during surgery [1] - The aim is to enhance the surgical resection effectiveness for related solid tumors, such as ovarian cancer and lung cancer, providing an innovative solution for precise navigation in tumor surgery with molecular targeting specificity and multidimensional biological sensing [1]

智通财经APP讯，复旦张江(688505.SH)发布公告，公司于近日收到国家药品监督管理局核准签发的 《受理通知书》，注射用FZ-P001钠用于已知或疑似肺癌患者术中恶性病变可视化的II期临床试验申请 获得受理。 注射用FZ-P001钠为公司自主研发的化学药品1类新化合物，是一种创新型光敏剂，其活性成分为叶酸 受体靶向小分子与花菁类光敏剂偶联而成的分子，可靶向叶酸受体α(FRα)高表达的恶性肿瘤组织并在近 红外区间荧光显影。公司计划使用该药物开发术中荧光指引技术，指示肿瘤恶性病变组织残留与切缘状 态，旨在提高相关实体瘤(如卵巢癌、肺癌等)手术切除效果，为肿瘤外科的精准导航手术提供兼具分子 靶向特异性和多维生物感知的创新解决方案。 ...

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。 股票代码：688505 股票简称：复旦张江 编号：临 2025-043 上海复旦张江生物医药股份有限公司自愿披露 关于注射用 FZ-P001 钠用于已知或疑似肺癌患者术中恶性病变 可视化获得药物临床试验申请受理通知书的公告 上海复旦张江生物医药股份有限公司（以下简称"公司"）于近日收到国家药 品监督管理局核准签发的《受理通知书》，注射用 FZ-P001 钠（以下简称"该药 物"）用于已知或疑似肺癌患者术中恶性病变可视化的 II 期临床试验申请获得受 理。由于药品的研发周期长、审批环节多，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： 一、药物的基本情况 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 二、药物的其他情况 原发性支气管肺癌简称肺癌，是我国及世界各国发病率和死亡率较高的恶性 肿瘤之一。据国家癌症中心 2024 年发布的数据显示 1，2022 年中国肺癌新发病例 1 Cance ...

Core Viewpoint - Fudan Zhangjiang has established itself as a leader in the global photodynamic therapy (PDT) drug sector, focusing on unmet clinical needs and achieving significant technological breakthroughs in biopharmaceutical innovation and industrialization [1][4]. Group 1: Photodynamic Drug Development - The company has developed four core technology platforms: photodynamic technology, nanotechnology, genetic engineering technology, and oral solid dosage technology, covering key areas such as skin diseases and malignant tumors [4]. - Fudan Zhangjiang has launched several globally and domestically innovative photodynamic therapy drugs, including Aira® (Ammonium Pentanoate) and Fumida® (Injectable Hematoporphyrin), which are already on the market in China [4][5]. - The company is recognized as having the most extensive product line and the highest sales revenue in the global photodynamic drug market [5]. Group 2: Expansion into ADC Drugs - Fudan Zhangjiang is expanding its product portfolio to include Antibody-Drug Conjugates (ADCs), with the FDA018 project currently in Phase III clinical trials, marking the closest pipeline to commercialization [7]. - The company has established a new ADC production base, which began operations in 2024, and has completed the scale-up of production processes for two ADC projects [7]. - The ongoing clinical trials and industrial production capabilities position ADC drugs as a significant new product group for the company, contributing to its growth trajectory [7]. Group 3: Market Position and Future Outlook - By focusing on unmet clinical needs, Fudan Zhangjiang has become a key driver in the development of photodynamic drugs both domestically and globally [8]. - The exploration of the ADC market is expected to provide new growth momentum, positioning the company as a leading innovator in the domestic pharmaceutical industry [8].

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 上海復旦張江生物醫藥股份有限公司 FF301 呈交日期: 2025年12月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01349 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 326,000,000 | RMB | | 0.1 RMB | | 32,600,000 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 326,000,000 | RMB | | 0.1 RMB | | 32,600,000 | | 2. 股份分類 | 普通股 | 股 ...

Core Viewpoint - Fudan Zhangjiang announced the election of Ms. Qu Yanan as the employee director of the company's eighth board of directors during the third employee representative conference scheduled for November 26, 2025 [1] Group 1 - The third employee representative conference will take place on November 26, 2025 [1] - Ms. Qu Yanan will be elected as the employee director [1]

复旦张江(01349)发布公告，公司于2025年11月26日召开第三届职工代表大会第三次会议，审议并通过 了《第八届董事会职工董事候选人及委任》的议案。经会议选举，曲亚楠女士获选为公司第八届董事会 职工董事。 ...

Core Viewpoint - Fudan Zhangjiang (01349) announced the election of a new employee director for its eighth board of directors during the third meeting of the third employee representative congress scheduled for November 26, 2025 [1] Group 1 - The third employee representative congress will be held on November 26, 2025 [1] - The agenda includes the review and approval of the candidate for the employee director of the eighth board of directors [1] - Ms. Qu Yanan was elected as the employee director of the eighth board of directors [1]

格隆汇11月26日丨复旦张江(01349.HK)宣布，于2025年11月26日举行的临时股东大会上获股东批准修订 公司章程并通过取消监事会的决议后，公司不再设监事会，并由公司董事会审核委员会行使《中华人民 共和国公司法》规定的监事会的职权。 ...

章 程 二〇二五年十一月 公司章程 第一章 總 則 1. 為維護上海復旦張江生物醫藥股份有限公司（以下稱「公司」）、公司股東、職工 及債權人的合法權益，規範公司的組織和行為，根據《中華人民共和國公司法》 （以下稱「《公司法》」）、《中華人民共和國證券法》（以下稱「《證券法》」）、《上 市公司章程指引》、《上海證券交易所科創板股票上市規則》、《香港聯合交易所有 限公司證券上市規則》（以下稱「香港上市規則」）等法律法規及規範性文件，制 定本章程。 公司系依照《公司法》和中華人民共和國（以下稱「中國」）其他有關法律、行 政法規成立的股份有限公司。 公司經上海市人民政府出具《關於同意設立上海復旦張江生物醫藥股份有限公司 的批復》（滬府體改審[2000]033 號）批准，由上海復旦張江生物醫藥有限公司整 體變更設立，於 2000 年 11 月 8 日在上海市工商行政管理局註冊登記，取得公司 營業執照。公司成立時的營業執照號碼為：3100001006533。 公司在香港聯合交易所有限公司（以下稱「香港聯交所」）創業板上市後，從中 國政府主管部門獲發《中華人民共和國外商投資企業批准證書》，並在上海市工 商行政管理局辦理變更 ...