Fudan-Zhangjiang(688505)
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复旦张江:复旦张江自愿披露关于注射用FDA018抗体偶联剂用于治疗三阴性乳腺癌Ⅲ期临床试验完成首例受试者入组的公告
2024-08-26 09:01
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 FDA018 抗体偶联剂用于治疗三阴性乳腺癌 股票代码:688505 股票简称:复旦张江 编号:临 2024-031 1 / 2 该药物 III 期临床试验为评价其在 TNBC 患者中的有效性、安全性、药代动 力学特征和免疫原性的随机、对照临床试验。截至本公告披露日,该药物研究已 完成首例受试者入组。 三、 风险提示 由于医药产品具有高科技、高风险、高附加值的特点,药品从临床前研究、 临床试验到商业化的周期长、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。 Ⅲ期临床试验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。 上海复旦张江生物医药股份有限公司(以下简称"公司")研发的注射用 FDA018 抗体偶联剂(即抗 Trop2 抗体偶联 SN38,以下简称"该药物")用于治 疗三阴性乳腺癌(TNBC)的药物Ⅲ期临床研究(以下简称"该研究")于近日 完成首例受试者入组。 一、 药物的相关情况 该药物由针对人滋养层 ...
复旦张江:复旦张江关于核心技术人员离职的公告
2024-08-21 10:15
上海复旦张江生物医药股份有限公司 关于核心技术人员离职的公告 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: 上海复旦张江生物医药股份有限公司(以下简称"公司"或"复旦张江")核 心技术人员张一帆先生因个人原因申请离职。离职后,张一帆先生将不再担任公 司任何职务; 张一帆先生在公司任职期间作为发明人申请的专利所有权均归属于公司 及子公司所有,不存在涉及职务发明的纠纷或潜在纠纷的情形;张一帆先生的离 职不会对公司的研发能力、持续经营能力和核心竞争力产生重大不利影响,不会 影响公司现有核心技术及研发项目的工作开展; 根据公司发展战略、经营策略、结构优化调整等因素综合考虑,公司本 次暂不新增其他核心技术人员。 一、核心技术人员离职的具体情况 公司核心技术人员张一帆先生因个人原因于近日向公司提出离职申请。离职 后,张一帆先生不再担任公司任何职务。公司对张一帆先生任职期间为公司发展 所做出的努力和贡献表示感谢。 股票代码:688505 股票简称:复旦张江 编号:临 2024-030 (三)保密情况 根据公司与张一帆先 ...
复旦张江:复旦张江2024年半年度权益分派实施公告
2024-08-21 10:11
重要内容提示: 每股现金红利 0.02 元(含税) 相关日期 | 股权登记日 | 除权(息)日 | 现金红利发放日 | | --- | --- | --- | | 2024/8/29 | 2024/8/30 | 2024/8/30 | H 股股东的现金分红有关情况详见本公司 2024 年 8 月 12 日于香港联交所网 站(www.hkex.com.hk)发布的相关公告。 一、 通过分配方案的股东大会届次和日期 证券代码:688505 证券简称:复旦张江 公告编号:临 2024-029 上海复旦张江生物医药股份有限公司 2024 年半年度权益分派实施公告 本公司董事会及全体董事保证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。 公司于 2024 年 6 月 27 日召开的 2023 年度股东周年大会已审议通过就 2024 年中期利润分配方案提请股东大会授权公司董事会在符合利润分配的条件下制定 具体分配方案,该利润分配预案已经公司第八届董事会第七次会议审议通过。 二、 分配方案 1. 发放年度:2024 年半年度 2. 分派对象: 截至股权登记日下午上 ...
复旦张江(01349) - 2024 - 中期业绩

2024-08-12 11:14
Financial Performance - The company's revenue for the first half of 2024 was RMB 408.12 million, a decrease of 21.94% compared to RMB 522.83 million in the same period last year[6]. - Net profit attributable to shareholders for the first half of 2024 was RMB 70.47 million, representing a 2.97% increase from RMB 68.44 million in the previous year[6]. - The net cash flow from operating activities for the first half of 2024 was RMB 27.65 million, a significant recovery from a negative cash flow of RMB 108.75 million in the same period last year[6]. - The total assets as of June 30, 2024, were RMB 2,848.70 million, a decrease of 0.97% from RMB 2,876.69 million at the end of the previous year[6]. - The company's total liabilities as of June 30, 2024, were RMB 2,357.42 million, slightly down from RMB 2,358.56 million at the end of the previous year[5]. - The net assets attributable to shareholders were RMB 2,356.54 million, a minor decrease of 0.04% from RMB 2,357.55 million at the end of the previous year[6]. - The overall operating income of the group has decreased compared to the previous year due to the underperformance of key products[61]. - The group reported a total operating income of ¥408,123,863, a decrease of 21.94% from ¥522,827,706 in the same period last year[64]. - The total comprehensive income attributable to shareholders was RMB 70.48 million, slightly down from RMB 70.61 million in the previous year[146]. Research and Development - The company's R&D expenditure accounted for 38.06% of its operating revenue, an increase of 15.38 percentage points compared to 22.68% in the same period last year[7]. - R&D expenses totaled CNY 155,330,149, an increase of 30.98% compared to the previous year[30]. - The company is focusing on innovative research and development in biomedicine, aiming to become a leader in the industry by addressing clinical treatment gaps[42]. - The company has established advanced technology platforms including gene engineering, photodynamic technology, and nanotechnology, focusing on differentiated competition and maximizing economic benefits[21]. - The company aims to enhance the research and registration of gene engineering technology projects that have entered clinical stages, targeting the commercialization of gene drugs[22]. - The company has filed for 17 new patents during the reporting period, with a total of 213 patents filed to date, of which 96 have been granted[29]. - The company has a strong pipeline in photodynamic therapy, with ongoing research on Ammonium Ketone Acid for treating HPV-related cervical diseases[33]. - The company is exploring new photodynamic compounds to improve efficacy and address existing limitations in treatment[24]. Market and Industry Trends - The Chinese pharmaceutical market is projected to grow from USD 221.4 billion in 2020 to USD 349.8 billion by 2025, reflecting a compound annual growth rate (CAGR) of 11.95%[13]. - The market for broad skin disease treatment and care in China increased from RMB 300.4 billion in 2017 to RMB 471.8 billion in 2021, with a CAGR of 11.95%[14]. - The incidence of skin diseases in China is rising, with approximately 150 million patients, highlighting a growing demand for effective treatments[14]. - The global oncology market is expected to reach USD 370 billion by 2027, driven by the introduction of new drugs and biosimilars[16]. - The Chinese market for skin disease treatments is expected to maintain a steady growth trajectory, supported by increasing health awareness and consumer spending[14]. Product Development and Innovation - The company aims to become a leader in the biopharmaceutical industry by focusing on innovative research and development[12]. - The company’s first photodynamic drug, Aira® (aminolevulinic acid), has significantly reduced the recurrence rate of genital warts compared to traditional therapies, filling a clinical gap in treating specific areas[19]. - The global first photodynamic drug for treating hemangiomas, Hemoporfin® (复美达®), was launched in 2017 and has shown high cure rates and low recurrence rates compared to traditional laser treatments[20]. - The company’s photodynamic therapy solutions have been included in major clinical treatment guidelines, indicating their recognition and acceptance in the medical community[19]. - The company has developed a photodynamic therapy platform, with key products including Ela® for treating genital warts and Fumida® for treating port-wine stains, both of which have shown significant market acceptance[23]. - The company is expanding the indications for Ela®, focusing on conditions such as cervical precancerous lesions and acne, and is conducting further research on the molecular mechanisms of photodynamic therapy[24]. - The company is focusing on antibody-drug conjugates, with a total investment of CNY 57,000,000 and significant progress in clinical research[32]. Financial Management and Strategy - The company has adopted a conservative financial policy, focusing on centralized management of funds and regular assessments of asset liquidity[67]. - The company plans to maintain liquidity and enhance overall capital returns through structured deposit investments[83]. - The company is adopting a cautious approach to R&D expenditure capitalization, considering the risks and challenges associated with innovative drug development[60]. - The company plans to pursue international registration for its marketed drugs to support its global expansion strategy[24]. - The company aims to leverage various bidding and centralized procurement opportunities to enhance the marketing capabilities of its products[61]. Corporate Governance and Compliance - The audit committee is responsible for reviewing financial reports and monitoring risk management[103]. - The financial performance for the six months ending June 30, 2024, was reviewed by the audit committee[103]. - The company adheres to applicable accounting standards and Hong Kong Listing Rules[103]. - The corporate governance framework includes various rules and regulations to ensure compliance and transparency[104]. - The company’s financial statements were approved by the board of directors on August 12, 2024, indicating ongoing governance and oversight[158]. Environmental Responsibility - The company invested RMB 797,700 in environmental protection during the reporting period[109]. - The company has established a complete management system for environmental protection, including a leadership team and annual updates to the team member list[112]. - The company has implemented carbon reduction measures, achieving a reduction of 94.92 tons of CO2 equivalent emissions[113]. - The company strictly adheres to national and local standards for pollutant emissions, including wastewater and waste gas, and has implemented comprehensive treatment measures[110]. - The company has not faced any administrative penalties related to environmental issues during the reporting period[110].
复旦张江:复旦张江关于2024年中期利润分配预案的公告
2024-08-12 10:08
股票代码:688505 股票简称:复旦张江 编号:临 2024-027 上海复旦张江生物医药股份有限公司 关于 2024 年中期利润分配预案的公告 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: 每 10 股派发现金红利人民币 0.2 元(含税),公司半年度不进行转增,不 送红股; 本次利润分配以实施权益分派股权登记日登记的总股本为基数,具体日 期将在权益分派实施公告中明确; 在实施权益分派的股权登记日前公司总股本发生变动的,拟维持每股派 发现金红利金额不变,相应调整分配的总额,并将另行公告具体调整情况。 一、2024年中期利润分配方案内容 本发生变动的,公司拟维持每股派发现金红利金额不变,相应调整分配的总额, 并将另行公告具体调整情况。 公司2023年度股东周年大会审议通过就该中期利润分配方案提请股东大会 授权公司董事会在符合利润分配的条件下制定具体分配方案。上述预案已经公司 董事会审议通过,实际分派的金额以公司发布的权益分派实施公告为准。 二、公司履行的决策程序 (一)董事会审核委员会意见 董事会审核委 ...
复旦张江:复旦张江第八届监事会第六次会议决议公告
2024-08-12 10:06
股票代码:688505 股票简称:复旦张江 编号:临2024-026 上海复旦张江生物医药股份有限公司 第八届监事会第六次会议决议公告 本公司监事会及全体监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。 一、监事会会议召开情况 上海复旦张江生物医药股份有限公司(以下简称"公司")第八届监事会第六 次会议于 2024 年 7 月 29 日以书面方式发出会议通知,于 2024 年 8 月 12 日以现 场表决方式召开,由公司监事会主席黄建先生主持,会议应参加表决的监事 3 人,实际参加表决的监事 3 人,本次会议的通知和召开符合《中华人民共和国公 司法》等法律、法规和《上海复旦张江生物医药股份有限公司章程》(以下简称 "《公司章程》")的有关规定。 二、监事会会议审议情况 经与会监事审议,做出如下决议: (一)审议通过《关于公司<2024 年半年度报告><2024 年半年度报告摘要> 及<截至二零二四年六月三十日止六个月期间中期业绩公告>的议案》 监事会认为:《公司 2024 年半年度报告》《公司 2024 年半年度报告摘要》及 《截至二零二四年 ...
复旦张江(688505) - 2024 Q2 - 季度财报
2024-08-12 10:06
Financial Performance - The company's operating revenue for the first half of 2024 was CNY 408,123,863, a decrease of 21.94% compared to the same period last year[18]. - Net profit attributable to shareholders for the same period was CNY 70,473,064, reflecting a slight increase of 2.97% year-on-year[18]. - The net profit after deducting non-recurring gains and losses was CNY 43,678,080, down 20.45% from the previous year[18]. - The net cash flow from operating activities was CNY 27,649,549, a significant recovery from a negative cash flow of CNY -108,754,157 in the previous year[18]. - The company's total assets at the end of the reporting period were CNY 2,848,696,380, a decrease of 0.97% from the end of the previous year[18]. - The net assets attributable to shareholders were CNY 2,356,542,326, showing a slight decrease of 0.04% compared to the previous year[18]. - Basic earnings per share remained stable at CNY 0.07, with diluted earnings per share also at CNY 0.07[19]. - The company reported a significant increase in prepayments, rising by 370.66% to 20,384,336 RMB from 4,330,980 RMB year-on-year[83]. - The company’s total liabilities decreased to RMB 491,273,588 as of June 30, 2024, down from RMB 518,124,139 at the end of 2023, representing a reduction of approximately 5.2%[134]. - The total equity attributable to shareholders was RMB 2,356,542,326, slightly down from RMB 2,357,553,851, indicating a decrease of about 0.04%[134]. Research and Development - Research and development expenses accounted for 38.06% of operating revenue, an increase of 15.38 percentage points compared to the previous year[19]. - The total R&D investment for the reporting period reached approximately ¥155.33 million, a 30.98% increase compared to the previous year, with R&D expenses accounting for 38.06% of operating revenue[45]. - The company has filed for 17 new patents during the reporting period, bringing the total number of patents obtained to 96[43]. - The company aims to broaden its R&D pipeline and enhance competitiveness in the biopharmaceutical sector through ongoing projects targeting rheumatoid arthritis, atopic dermatitis, and other conditions[48]. - The company is focusing on innovative research and development in photodynamic therapy (PDT) and photodynamic diagnosis (PDD) for various skin diseases and cancers[60]. Market and Industry Trends - The biopharmaceutical industry is projected to grow at a compound annual growth rate (CAGR) of 3%-6% from 2023 to 2027, with a total market size reaching approximately USD 1.9 trillion[24]. - The Chinese dermatology drug market grew from RMB 300.4 billion in 2017 to RMB 471.8 billion in 2021, with a CAGR of 11.95%[25]. - The global oncology spending is expected to reach USD 370 billion by 2027, driven by the introduction of new drugs and biosimilars[29]. Product Development and Sales - The sales revenue from the company's pharmaceutical products is primarily derived from dermatology products, with significant contributions from the photodynamic drug Aira® for the treatment of genital warts, which has become a clinical first-choice drug since its launch in 2007[31]. - The company terminated its marketing service agreement with Shanghai Huizheng, which contributed to the decline in sales of its main product, Libao Duo®[19]. - The sales of liposomal doxorubicin injection (Ribao Duo®) reached approximately RMB 3.6 billion in 2023, showing a cumulative sales growth of 38.46% over six years since its launch in 2009[34]. - The company’s products have shown significant advantages in terms of safety and efficacy, with lower adverse reaction rates and recurrence rates compared to traditional therapies[32]. Corporate Governance and Compliance - The board of directors has confirmed the authenticity, accuracy, and completeness of the financial report[4]. - The company has not engaged in any non-operating fund occupation by controlling shareholders or related parties[7]. - There are no violations of decision-making procedures regarding external guarantees[7]. - The company has committed to reducing related party transactions to avoid adverse impacts on shareholders[110]. - The company has established strict compliance with relevant laws and regulations regarding share reduction and timely information disclosure obligations[106]. Environmental Responsibility - The company invested 797,700 CNY in environmental protection during the reporting period[98]. - The company reduced carbon emissions by 94.92 tons through measures such as clean energy generation and improving production energy efficiency[101]. - The company established a comprehensive environmental management system and updated its five-year environmental goals based on 2023[100]. - The company strictly controls wastewater discharge and complies with national and local standards for pollutant emissions[98]. Future Outlook and Strategy - The company plans to continue leveraging its photodynamic therapy's unique characteristics to explore new treatment mechanisms and improve efficacy[37]. - The company aims to balance innovation and industrialization while enhancing its core competitiveness in the biopharmaceutical sector[59]. - The company plans to expand its market presence in Southeast Asia, targeting a 15% growth in revenue from this region by the end of 2025[163]. - The company anticipates a revenue growth rate of 10% for the upcoming fiscal year, driven by new product launches and market expansion strategies[163].
复旦张江:复旦张江2024年半年度募集资金存放与实际使用情况专项报告的公告
2024-08-12 10:06
股票代码:688505 股票简称:复旦张江 编号:临2024-028 上海复旦张江生物医药股份有限公司 2024 年半年度募集资金存放与实际使用情况专项报告的公告 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。 上海复旦张江生物医药股份有限公司(以下简称"公司")根据中国证券监督管理委员会 《上市公司监管指引第2号—上市公司募集资金管理和使用的监管要求》《上海证券交易所 科创板股票上市规则》及《上海证券交易所科创板上市公司自律监管指引第1号——规范运 作》等相关规定要求,现将2024年半年度(以下简称"本报告期")募集资金存放与实际使 用情况报告如下: 一、募集资金基本情况 (一)实际募集资金的金额及到账情况 根据中国证券监督管理委员会于2020年5月14日出具的《关于同意上海复旦张江生物医 药股份有限公司首次公开发行股票注册的批复》(证监许可[2020]912号),同意上海复旦 张江生物医药股份有限公司首次公开发行股票的注册申请。公司公开发行人民币普通股 120,000,000股,发行价格为人民币8.95元/股,募集资金 ...
复旦张江:复旦张江关于召开2024年半年度业绩说明会的公告
2024-08-02 08:26
股票代码:688505 股票简称:复旦张江 公告编号:临 2024-025 上海复旦张江生物医药股份有限公司 会议线上交流时间:2024 年 8 月 13 日(周二)上午 11:00-12:00 会议召开地点:上海证券交易所上证路演中心(网址:http://roadshow.sseinfo.com/) 会议召开方式:上证路演中心网络互动 关于召开 2024 年半年度业绩说明会的公告 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: 投资者可于 2024 年 08 月 06 日(周二)至 08 月 12 日(周一)16:00 前登录 上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 ir@fd-zj.com 进 行提问。公司将在说明会上对投资者普遍关注的问题进行回答。 上海复旦张江生物医药股份有限公司(以下简称"公司")将于 2024 年 8 月 13 日于上海证券交易所网站(www.sse.com.cn)披露《上海复旦张江生物医药股 份有限公司 2024 年半年度报告》。为便于广大投资者全面深入地了解 ...
复旦张江:复旦张江H股公告
2024-08-01 08:58
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或完 整性亦不發表任何聲明,並明確表示概不因本公告全部或任何部份內容而產生或因依賴該等內容而 引致的任何損失承擔任何責任。 須予披露的交易 認購浦發銀行結構性存款產品 認購結構性存款產品 於二零二四年八月一日,本公司與浦發銀行訂立浦發銀行結構性存款產品協議,同意以日常營運 產生的自有閑置資金向浦發銀行認購總金額為人民幣 2.00 億元的結構性存款產品。 - 1 - 上市規則的涵義 在訂立浦發銀行結構性存款產品協議時,就浦發銀行結構性存款產品協議項下產品的認購金額而 言,一項或多項適用百分比率(定義見上市規則第 14.07 條)超過 5%但均低於 25%,故根據上市 規則第 14 章,该交易構成本公司之須予披露的交易,須遵守上市規則第 14 章有關申報及公告之 規定,惟獲豁免遵守獨立股東批准之規定。 概述 於二零二四年八月一日,本公司與浦發銀行訂立浦發銀行結構性存款產品協議,同意以日常營運產 生的自有閑置資金向浦發銀行認購金額為人民幣 2.00 億元的結構性存款產品。 浦發銀行結構性存款產品協議 本公司與浦發銀行訂立之結構性存款產 ...