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复旦张江:获得药物临床试验申请受理通知书
Group 1 - The core point of the article is that Fudan Zhangjiang (688505) has received approval from the National Medical Products Administration for the clinical trial application of FZ-P001 sodium for visualizing malignant lesions in known or suspected lung cancer patients during surgery [1] Group 2 - The clinical trial is categorized as a Phase II trial, indicating that it is in the second stage of testing for safety and efficacy [1]
复旦张江: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临床试验获受理
Zhi Tong Cai Jing· 2025-12-25 10:36
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]
复旦张江(688505.SH):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临床试验获受理
智通财经网· 2025-12-25 10:36
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。 ...
复旦张江(688505) - 复旦张江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
2025-12-25 10:30
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 ...
智通港股通资金流向统计(T+2)|12月25日
智通财经网· 2025-12-24 23:35
Core Insights - Tencent Holdings (00700), Alibaba-W (09988), and Hong Kong Exchanges (00388) led the market in net inflows, with amounts of 1.115 billion, 1.055 billion, and 309 million respectively [1] - China Mobile (00941), Luoyang Molybdenum (03993), and CICC (03908) experienced the highest net outflows, with amounts of -1.053 billion, -184 million, and -181 million respectively [1] - In terms of net inflow ratios, China Telecom Services (00552), Yihua Tong (02402), and Sunshine Insurance (06963) topped the list with ratios of 167.31%, 126.18%, and 118.17% respectively [1] Net Inflow Rankings - Tencent Holdings (00700) had a net inflow of 1.115 billion, representing a 13.09% increase, closing at 614.500 [2] - Alibaba-W (09988) saw a net inflow of 1.055 billion, with a 12.23% increase, closing at 146.400 [2] - Hong Kong Exchanges (00388) recorded a net inflow of 309 million, with a 24.77% increase, closing at 407.000 [2] Net Outflow Rankings - China Mobile (00941) faced a net outflow of -1.053 billion, a decrease of -54.21%, closing at 83.700 [2] - Luoyang Molybdenum (03993) had a net outflow of -184 million, down by -29.82%, closing at 19.100 [2] - CICC (03908) experienced a net outflow of -181 million, a decrease of -30.22%, closing at 20.540 [2] Net Inflow Ratio Rankings - China Telecom Services (00552) achieved a net inflow ratio of 167.31%, with a net inflow of 26.5926 million, closing at 4.520 [3] - Yihua Tong (02402) had a net inflow ratio of 126.18%, with a net inflow of 26.5481 million, closing at 23.980 [3] - Sunshine Insurance (06963) recorded a net inflow ratio of 118.17%, with a net inflow of 31.5558 million, closing at 3.940 [3]
2025年度影响力企业:以临床需求为锚,复旦张江构筑光动力+ADC创新双极
Di Yi Cai Jing· 2025-12-20 06:57
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].
智通AH统计|12月15日
智通财经网· 2025-12-15 08:20
Core Insights - The article highlights the top and bottom AH share premium rates as of December 15, with Northeast Electric (00042) leading at a premium of 900.00% and CATL (03750) at the bottom with a premium of -11.03% [1][2][3] Premium Rate Rankings - The top three AH stocks by premium rate are: - Northeast Electric (00042) with a premium of 900.00% and a deviation value of 26.91% [1][2] - Beijing Capital Machinery (00187) with a premium of 266.67% and a deviation value of 27.25% [1][2] - Hongye Futures (03678) with a premium of 265.78% and a deviation value of -3.92% [1][2] - The bottom three AH stocks by premium rate are: - CATL (03750) with a premium of -11.03% and a deviation value of -2.28% [1][3] - China Merchants Bank (03968) with a premium of -0.77% and a deviation value of -0.05% [1][3] - Heng Rui Medicine (01276) with a premium of 1.62% and a deviation value of -1.73% [1][3] Deviation Value Rankings - The top three AH stocks by deviation value are: - Beijing Capital Machinery (00187) with a deviation value of 27.25% [1][4] - Northeast Electric (00042) with a deviation value of 26.91% [1][4] - Hongxing Meikailong (01528) with a deviation value of 18.57% [1][4] - The bottom three AH stocks by deviation value are: - GAC Group (02238) with a deviation value of -19.95% [1][5] - First Tractor Company (00038) with a deviation value of -16.78% [1][5] - Longyuan Power (00916) with a deviation value of -13.18% [1][5]
智通AH统计|12月3日
智通财经网· 2025-12-03 08:19
Core Insights - The article highlights the top and bottom AH share premium rates as of December 3, with Northeast Electric (00042) leading at a premium rate of 900.00% [1][2]. Group 1: Top AH Share Premium Rates - Northeast Electric (00042) has the highest premium rate at 900.00% with H-share priced at 0.270 HKD and A-share at 2.25 CNY [2]. - Hongye Futures (03678) follows with a premium rate of 276.85%, H-share at 3.240 HKD and A-share at 10.19 CNY [2]. - Sinopec Oilfield Service (01033) ranks third with a premium rate of 265.79%, H-share at 0.760 HKD and A-share at 2.32 CNY [2]. Group 2: Bottom AH Share Premium Rates - Contemporary Amperex Technology (03750) has the lowest premium rate at -4.88%, with H-share priced at 473.600 HKD and A-share at 376.08 CNY [2]. - China Merchants Bank (03968) has a premium rate of -0.25%, H-share at 51.650 HKD and A-share at 43.01 CNY [2]. - Heng Rui Medicine (01276) follows with a premium rate of 1.71%, H-share at 71.800 HKD and A-share at 60.97 CNY [2]. Group 3: Premium Deviation Values - Guanghe Communication (00638) has the highest deviation value at 49.00% [1][3]. - Northeast Electric (00042) also features prominently with a deviation value of 36.60% [1][3]. - Chenming Paper (01812) ranks third with a deviation value of 26.74% [1][3]. Group 4: Bottom Premium Deviation Values - GAC Group (02238) has the lowest deviation value at -26.76% [1][3]. - Junsheng Electronics (00699) follows with a deviation value of -18.54% [1][3]. - Jiangsu Ninghu Highway (00177) has a deviation value of -15.01% [1][3].
复旦张江(01349) - 截至二零二五年十一月三十日止股份发行人的证券变动月报表
2025-12-01 09:01
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 ...
智通AH统计|12月1日
智通财经网· 2025-12-01 08:16
Core Insights - The article highlights the top and bottom AH premium rates for various stocks as of December 1, with Northeast Electric (00042) leading with a premium rate of 881.82% [1] - The article also lists the stocks with the highest and lowest deviation values, indicating significant discrepancies between their A-shares and H-shares [1] Summary of Top AH Premium Rates - Northeast Electric (00042) has the highest AH premium rate at 881.82%, followed by Hongye Futures (03678) at 274.55% and Sinopec Oilfield Service (01033) at 269.74% [1] - The top ten stocks with high premium rates include Zhejiang Shibao (01057) at 261.98% and Chenming Paper (01812) at 245.83% [1] Summary of Bottom AH Premium Rates - The stocks with the lowest AH premium rates include Ningde Times (03750) at -5.03%, China Merchants Bank (03968) at -1.36%, and Heng Rui Medicine (01276) at 1.50% [1] - Other notable mentions in the bottom list include Weichai Power (02338) at 6.45% and Midea Group (00300) at 7.66% [1] Summary of Deviation Values - The stocks with the highest deviation values are Guanghe Communication (00638) at 31.56%, Dazhong Public Utilities (01635) at 23.38%, and Beijing Jingcheng Machinery Electric (00187) at 20.11% [1] - Conversely, the stocks with the lowest deviation values include Jiangsu Ninghu Expressway (00177) at -13.73%, Junsheng Electronics (00699) at -12.81%, and China Life (02628) at -11.45% [1]