Fudan-Zhangjiang(01349)

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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(01349) - 2024 Q1 - 季度业绩
2024-04-29 09:02
Revenue and Profitability - Revenue for the first quarter was RMB 147,647,109, representing a decrease of 21.94% compared to the same period last year[2] - Net profit attributable to shareholders decreased by 73.29% to RMB 2,347,396[2] - Net profit attributable to shareholders after deducting non-recurring gains and losses was RMB -4,515,799, a decline of 292.19%[2] - The company's total operating revenue for Q1 2024 was RMB 147,647,109, a decrease of 22% compared to RMB 189,147,552 in Q1 2023[13] - Operating profit for Q1 2024 was RMB 1,190,039, down from RMB 3,481,590 in Q1 2023, reflecting a significant decline in profitability[13] - The net profit attributable to shareholders for Q1 2024 was RMB 2,347,396, compared to RMB 8,787,158 in the same period last year, indicating a decrease of approximately 73%[13] Research and Development - Research and development expenses totaled RMB 64,173,693, an increase of 17.73% year-on-year[2] - R&D expenses accounted for 43.46% of revenue, up by 14.64 percentage points from the previous year[2] - Research and development expenses for Q1 2024 were RMB 63,616,910, an increase from RMB 54,123,028 in Q1 2023, indicating a focus on innovation despite declining revenues[13] Cash Flow and Liquidity - The net cash flow from operating activities was RMB 43,938,388, a significant improvement from RMB -16,026,020 in the same period last year[5] - In Q1 2024, cash inflow from operating activities was RMB 244,729,122, a 50.0% increase from RMB 162,901,241 in Q1 2023[14] - The net cash flow from operating activities was RMB 43,938,388, compared to a negative RMB 160,260,214 in the same period last year[14] - Cash outflow for purchasing goods and services decreased significantly to RMB 82,458,828 from RMB 228,636,546, marking a 64.0% reduction[14] - The net increase in cash and cash equivalents for the quarter was RMB 37,498,452, compared to a decrease of RMB 401,292,835 in Q1 2023[14] - The ending balance of cash and cash equivalents was RMB 1,233,394,449, up from RMB 888,009,829 in the previous year[14] Assets and Liabilities - Total assets at the end of the reporting period were RMB 2,825,346,356, a decrease of 1.78% from the end of the previous year[2] - Total current assets decreased to RMB 1,833,318,779 from RMB 1,869,424,886, reflecting a decline of about 2%[11] - Total liabilities decreased to RMB 464,492,233 as of March 31, 2024, down from RMB 518,124,139 at the end of 2023, representing a reduction of approximately 10%[12] - Equity attributable to shareholders increased slightly by 0.10% to RMB 2,359,932,124[2] Strategic Changes - The company terminated its cooperation with a promotional service provider, impacting sales revenue of a key product during the reporting period[5] - The company plans to terminate its marketing cooperation with Shanghai Huizheng due to underperformance of its product, Liboduo, which has led to a significant drop in revenue[10] - The company is adjusting its sales strategy for Liboduo by selecting specialized CSO companies for regional marketing and academic promotion to enhance communication efficiency and reduce operational risks[10] - The company aims to leverage various bidding and procurement opportunities to enhance its market presence and adapt its promotional strategies to local conditions[10] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 20,860[8] Cash Flow from Investments - Cash inflow from investment activities was RMB 919,724,441, down 13.0% from RMB 1,055,510,659 in Q1 2023[14] - The net cash flow from investment activities was negative RMB 3,807,572, an improvement from negative RMB 235,735,353 year-over-year[14] Financing Activities - Cash outflow related to financing activities decreased to RMB 2,669,076 from RMB 5,251,044, a reduction of 49.2%[14] Accounting Standards - The company has not applied new accounting standards or interpretations for the first quarter of 2024[15]
复旦张江(01349) - 2023 - 年度财报
2024-04-29 08:52
复旦我江 FUDAN-ZHANGJIANG 上 海 復 旦 張 江 生 物 醫 藥 股 份 有 限 公 司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. (於中華人民共和國註冊成立的股份有限公司) (股票號碼:1349) 2023 報 * 僅供識別 目錄 | --- | --- | --- | --- | |-------|-------|----------------------------|--------| | | | | | | | | | | | | | 公司資料 | 頁碼 2 | | | | 五年財務摘要 | 4 | | | | 主席報告 | 6 | | | | 管理層的討論及分析 | 19 | | | | 董事會報告 | 36 | | | | 監事會報告 | 66 | | | | 審核委員會報告 | 68 | | | | 薪酬委員會報告 | 71 | | | | 提名委員會報告 | 73 | | | | 戰略委員會報告 | 75 | | | | 企業管治報告 | 77 | | | | 董事、監事及高級管理層簡介 | 108 | | ...
复旦张江(01349) - 2023 - 年度业绩
2024-03-28 14:18
Financial Performance - The company's revenue for the year ended December 31, 2023, was RMB 850,733,000, a decrease of 17.5% compared to RMB 1,031,160,000 in 2022[2] - Profit before tax for the same period was RMB 97,528,000, down 26.3% from RMB 132,294,000 in the previous year[2] - The net profit attributable to shareholders for 2023 was RMB 108,627,000, a decline of 21.3% from RMB 137,997,000 in 2022[2] - The company reported a total comprehensive income of RMB 107,793,000 for 2023, compared to RMB 136,122,000 in 2022, indicating a decline of 20.8%[2] - The total operating profit for 2023 was RMB 45,580,116, down from RMB 105,919,554 in 2022[13] - The company reported a net financial loss of ¥3,703,638 in 2023, compared to a loss of ¥8,788,607 in 2022, showing an improvement[188] - The total profit for 2023 was RMB 97,528,063, a decrease of 26.3% compared to RMB 132,293,548 in 2022[197] Assets and Liabilities - Total assets as of December 31, 2023, amounted to RMB 2,876,688,000, a decrease from RMB 2,976,007,000 in 2022[3] - Total liabilities decreased to RMB 518,124,000 in 2023 from RMB 722,986,000 in 2022, representing a reduction of 28.3%[3] - Cash and cash equivalents as of December 31, 2023, were RMB 1,195,895,997, down from RMB 1,289,302,664 in 2022[4] - The company's total equity attributable to shareholders increased to RMB 2,357,554,000 in 2023 from RMB 2,257,102,000 in 2022, marking an increase of 4.4%[3] - The company's total equity as of December 31, 2023, was RMB 2,358,563,368, an increase from RMB 2,253,021,355 at the end of 2022[18] - The company's total equity as of December 31, 2023, was RMB 2,379,229,295, an increase from RMB 2,321,921,130 at the end of 2022[20] Earnings Per Share - The company's basic and diluted earnings per share for 2023 were RMB 0.1051, down from RMB 0.1340 in 2022, reflecting a decrease of 21.5%[2] - Basic earnings per share for 2023 were RMB 0.11, down from RMB 0.13 in 2022, a decrease of 15.4%[12] - Diluted earnings per share remained at RMB 0.11 for 2023, unchanged from 2022 despite adjustments for potential ordinary shares[200] Cash Flow - Cash flow from operating activities for 2023 was RMB 71,015,450, down from RMB 165,268,622 in 2022[14] - The net cash flow from operating activities in 2023 was RMB 10,422,159, down from RMB 122,058,916 in 2022, indicating a significant decline[15] - The total cash inflow from investment activities in 2023 was RMB 3,835,875,490, an increase of 10.5% from RMB 3,469,785,915 in 2022[15] - The cash outflow for investment activities in 2023 was RMB 3,848,247,323, compared to RMB 3,500,564,593 in 2022, reflecting a rise of 9.9%[15] - The company's cash balance at the end of 2023 was RMB 1,067,294,432, down from RMB 1,187,769,137 at the end of 2022[15] Research and Development - Research and development expenses increased to RMB 243,762,975 in 2023, compared to RMB 226,850,903 in 2022, reflecting a growth of 7.4%[10] - The total research and development expenses for 2023 were RMB 244,700,356, an increase from RMB 233,659,131 in 2022[145][146] - R&D expenses for 2023 totaled ¥94,014,517, slightly down from ¥95,009,511 in 2022, while salary expenses in R&D increased to ¥75,383,005 from ¥57,590,255[187] Inventory and Receivables - The inventory increased to RMB 29,993,697 in 2023 from RMB 19,268,923 in 2022, an increase of 55.5%[9] - The provision for bad debts increased to RMB 35,993,681 as of December 31, 2023, compared to RMB 12,365,732 on December 31, 2022, reflecting a significant rise in credit loss provisions[98][102] - The aging analysis of accounts receivable shows that the amount overdue within one year was RMB 476,025,167, down from RMB 516,855,117 in the previous year, indicating improved collection efficiency[99] - The total amount of accounts receivable written off during the year was RMB 271,600, with a corresponding bad debt provision of the same amount[106] Government Grants and Taxation - The company received government subsidies related to income amounting to ¥20,638,461 in 2023, compared to ¥7,868,017 in 2022, indicating a substantial increase[191] - The corporate income tax rate applicable to the company for 2023 remains at 15%, consistent with 2022[90] - The company has received the "High-tech Enterprise Certificate" valid for three years, allowing it to maintain the reduced corporate income tax rate of 15%[89] Accounting Policies and Compliance - The company has updated its accounting policies in accordance with the Ministry of Finance's guidelines, which did not have a significant impact on the financial statements[3] - The financial statements were approved by the board of directors on March 28, 2024, indicating a commitment to transparency and compliance[23] - The company’s accounting policies are aligned with the Chinese Accounting Standards and reflect its operational characteristics[24] Shareholder Information - The company distributed dividends totaling RMB 72,560,047 to shareholders in 2023[18] - The company declared a cash dividend of RMB 0.07 per share for the 2022 fiscal year, totaling RMB 72,560,047 based on 1,036,572,100 shares issued[179]
复旦张江:复旦张江自愿披露关于盐酸氨酮戊酸颗粒剂用于乳腺癌手术可视化获得药物临床试验申请受理通知书的公告
2023-11-13 09:28
上海复旦张江生物医药股份有限公司 自愿披露关于盐酸氨酮戊酸颗粒剂用于乳腺癌手术可视化 股票代码:688505 股票简称:复旦张江 编号:临 2023-050 获得药物临床试验申请受理通知书的公告 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")于近日收到国家药 品监督管理局核准签发的《受理通知书》,盐酸氨酮戊酸颗粒剂用于成人保乳手 术中乳腺癌可视化的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、 药品的基本情况 药物名称:盐酸氨酮戊酸颗粒剂 注册分类:化学药品 2.4 类 申请事项:境内生产药品注册临床试验 受 理 号:CXHL2301260 申 请 人:上海复旦张江生物医药股份有限公司 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、 药品的其他情况 1 / 2 行技术尚不足以帮助医师实时判断肿瘤是否切除完全。 ...
复旦张江:复旦张江自愿披露关于盐酸多柔比星脂质体注射液通过一致性评价的公告
2023-11-08 09:18
股票代码:688505 股票简称:复旦张江 编号:临 2023-049 上海复旦张江生物医药股份有限公司 自愿披露关于盐酸多柔比星脂质体注射液通过一致性评价的公告 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")于近日收到国家药 品监督管理局核准签发的化学药品注射剂仿制药质量和疗效一致性评价《药品补 充申请批准通知书》(通知书编号:2023B05505),盐酸多柔比星脂质体注射液(商 品名:里葆多®)(以下简称"该药物")通过仿制药质量和疗效一致性评价。现 将相关情况公告如下: 一、 药品的基本情况 药物名称:盐酸多柔比星脂质体注射液 规 格:10ml:20mg 申请事项:仿制药质量和疗效一致性评价 注册分类:原化学药品 6 类 1 / 2 三、 对公司的影响及风险提示 受 理 号:CYHB2250452 原药品批准文号:国药准字 H20084432 药品上市许可持有人:上海复旦张江生物医药股份有限公司 二、 药品的其他情况 本公司纳米技术平台治疗肿瘤的里葆多®于二零零九 ...
复旦张江(01349) - 2023 Q3 - 季度业绩
2023-10-30 09:10
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。 上 海 復 旦 張 江 生 物 醫 藥 股 份 有 限 公 司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.* Shanghai Fudan-Zhangiiang Bio-Pharmaceutical Co., Ltd.* 截至二零二三年九月三十日止九个月期間 第三季度業績公告 上海復旦張江生物醫藥股份有限公司(「本公司」,聯同其附屬公司,「本集團」)之董 事會(「董事會」)欣然宣佈本集團截至二零二三年九月三十日止九個月期間之第三季度 按照中國企業會計準則編製的未經審計財務資料(「第三季度業績公告」)。本公告乃根 據香港法例第 571 章證券及期貨條例第 XIVA 部項下內幕消息條文及香港聯合交易所有限 公司證券上市規則第 13.09(2)和第 13.10B 條的要求作出。 主要財務數據 主要會計數據和財務指標 單位:元 幣種:人民幣 | -- ...
复旦张江:复旦张江关于核心技术人员离职的公告
2023-10-27 09:26
关于核心技术人员离职的公告 股票代码:688505 股票简称:复旦张江 编号:临 2023-048 上海复旦张江生物医药股份有限公司 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 心技术人员杨彤先生因个人原因于近日向公司提出离职申请,并已办理完成离职 手续。离职后,杨彤先生将不再担任公司任何职务; 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。 (一)核心技术人员的具体情况 杨彤先生,1976 年出生,中国籍,无境外永久居留权。2002 年 7 月获吉林 大学生物化学硕士学位。2002 年 7 月起,历任公司生物技术药物研发部研发人 员、副经理、经理、研发总监。 杨彤先生负责的工作已完成交接,公司生物技术药物研发部门的研究开 发及运营管理等工作均有序推进。杨彤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。 截至本公告披露日,杨彤先生未直接或间接持有公司股份。根据公司《2021 年限制性股票激励计划》规定,其 ...
复旦张江:海通证券股份有限公司关于上海复旦张江生物医药股份有限公司核心技术人员离职的核查意见
2023-10-27 09:26
海通证券股份有限公司 关于上海复旦张江生物医药股份有限公司 核心技术人员离职的核查意见 上海证券交易所: 经中国证券监督管理委员会《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)批复,上海复旦张江 生物医药股份有限公司(以下简称"上市公司"、"公司"或"发行人")首次公开发 行股票 12,000 万股,每股面值人民币 0.1 元,每股发行价格人民币 8.95 元,募 集资金总额为人民币 107,400.00 万元,扣除发行费用后,实际募集资金净额为人 民币 97,432.39 万元。本次发行证券已于 2020 年 6 月 19 日在上海证券交易所上 市。海通证券股份有限公司(以下简称"保荐机构"或"海通证券")担任其持续 督导保荐机构,持续督导期间为 2020 年 6 月 19 日至 2023 年 12 月 31 日。 根据《证券发行上市保荐业务管理办法》《上海证券交易所科创板股票上市 规则》等有关法律、法规要求,海通证券作为持续督导保荐机构,对公司核心技 术人员离职事项进行了专项核查,现将本次核查的情况报告如下: (三)保密情况 一、核心技术人员离职 ...
复旦张江:复旦张江自愿披露关于注射用FZ-AD005抗体偶联剂用于治疗晚期实体瘤获得药物临床试验申请受理通知书的公告
2023-10-20 09:06
上海复旦张江生物医药股份有限公司 股票代码:688505 股票简称:复旦张江 编号:临 2023-047 申 请 人: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-AD005 抗体偶联剂用于治疗晚期实体瘤 获得药物临床试验申请受理通知书的公告 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")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-AD005 抗体偶联剂(即抗 DLL3 抗体偶联 BB05,以下简称"该药物")用于治疗晚期实体瘤的药物 I 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、 药品的基本情况 药物名称:注射用 FZ-AD005 抗体偶联剂 注册分类:治疗用生物制品 1 类 申请事项:境内生产药品注册临床试验 受 理 号:CXSL2300717 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, ...