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复旦张江:复旦张江自愿披露关于奥贝胆酸片用于治疗原发性胆汁性胆管炎的药品上市申请获得受理的公告
2024-10-31 08:41
股票代码:688505 股票简称:复旦张江 编号:临 2024-035 上海复旦张江生物医药股份有限公司 自愿披露关于奥贝胆酸片用于治疗原发性胆汁性胆管炎 药品上市申请获得受理的公告 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")全资子公司泰州 复旦张江药业有限公司于近日收到国家药品监督管理局(以下简称"国家药监局") 下发的关于奥贝胆酸片(规格:5mg、10mg)(以下简称"该药品")用于治疗原 发性胆汁性胆管炎(PBC)的境内生产药品注册上市许可申请的《受理通知书》, 现将相关情况公告如下: 一、 药品的基本情况 申请事项:境内生产药品注册上市许可 受 理 号:CYHS2403676、CYHS2403677 申 请 人:泰州复旦张江药业有限公司 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 该药品属于法尼酯 X 受体(Farnesoid X receptor,FXR)激动剂,FXR 是一 种在肝脏和肠道中 ...
复旦张江(688505) - 2024 Q3 - 季度财报
2024-10-25 11:32
Financial Performance - The company's operating revenue for the third quarter was ¥140,724,701, a decrease of 23.99% compared to the same period last year, and a year-to-date revenue of ¥548,848,564, down 22.47% year-on-year[2]. - The net profit attributable to shareholders for the third quarter was ¥15,995,540, a decline of 25.44%, with a year-to-date net profit of ¥86,468,604, down 3.81% year-on-year[2]. - The net profit attributable to shareholders after deducting non-recurring gains and losses for the third quarter was ¥10,822,388, a decrease of 34.74%, with a year-to-date figure of ¥54,500,468, down 23.76% year-on-year[2]. - Total operating revenue for the first three quarters of 2024 was RMB 548,848,564, a decrease of 22.5% compared to RMB 707,960,683 in the same period of 2023[16]. - Net profit for the first three quarters of 2024 was RMB 86,171,568, a slight decrease of 4.6% compared to RMB 89,811,290 in the same period of 2023[17]. - Basic and diluted earnings per share for the first three quarters were both RMB 0.08, down from RMB 0.09 in the previous year[18]. Research and Development - Research and development (R&D) expenses totaled ¥79,540,074 for the third quarter, an increase of 56.79%, with year-to-date R&D expenses of ¥234,870,223, up 38.71% year-on-year[4]. - The ratio of R&D expenses to operating revenue was 56.52% for the third quarter, an increase of 29.12 percentage points, and 42.79% year-to-date, up 18.87 percentage points year-on-year[4]. - Research and development expenses increased significantly to RMB 235,745,108, up 40% from RMB 168,541,486 in the previous year[16]. Cash Flow and Liquidity - The net cash flow from operating activities for the year-to-date was -¥60,152,607, a significant decrease of 3,613.16% year-on-year[4]. - Cash flow from operating activities showed a net outflow of RMB 60,152,607, contrasting with a net inflow of RMB 1,712,208 in the same period last year[20]. - The net increase in cash and cash equivalents was -157,352,803, compared to -46,840,367 in the previous period[21]. - The ending balance of cash and cash equivalents was 1,038,543,194, down from 1,242,462,297 in the previous period[21]. - The company paid 91,127,687 in dividends and interest, an increase from 74,615,047 in the previous period[21]. Assets and Liabilities - The total assets at the end of the reporting period were ¥2,627,120,117, a decrease of 8.68% compared to the end of the previous year[4]. - The company's current assets totaled RMB 1,656,774,707, down from RMB 1,869,424,886, indicating a decrease of about 11.35%[13]. - Total liabilities decreased to RMB 274,499,573 from RMB 518,124,139, a significant reduction of about 47.14%[14]. - The company's equity attributable to shareholders was RMB 2,351,908,069, slightly down from RMB 2,357,553,851, a decrease of about 0.24%[14]. Shareholder Information - The company has a total of 20,006 shareholders, with 19,870 holding A shares and 136 holding H shares[11]. - The largest shareholder, Shanghai Pharmaceutical Group Co., Ltd., holds a total of 210,142,560 shares, including 139,578,560 A shares and 70,564,000 H shares[11]. Other Financial Metrics - The weighted average return on net assets was 0.68%, a decrease of 0.24 percentage points for the quarter, and 3.66% year-to-date, down 0.25 percentage points[4]. - Total operating costs decreased to RMB 490,043,765, down 18.4% from RMB 600,143,402 year-on-year[16]. - Sales expenses decreased to RMB 173,777,581, down 47.9% from RMB 333,644,772 year-on-year[16]. - Tax expenses increased to RMB 5,299,582, compared to RMB 3,893,911 in the same period of 2023[16]. - Other comprehensive income after tax showed a loss of RMB 222,673, compared to a loss of RMB 164,801 in the previous year[18]. Investment Activities - Total cash inflow from investment activities was RMB 3,069,165,185, slightly up from RMB 3,056,147,909 in the previous year[20]. - The company reported a total cash outflow from investing activities of 3,091,638,335, compared to 3,068,186,518 in the previous period[21]. - Cash flow from investing activities totaled 3,068,186,518, with a net cash flow of 978,667, compared to a negative cash flow of 35,490,426 in the previous period[21]. Accounting Standards - The company is not applying the new accounting standards for the current reporting period[22].
复旦张江:前三季度净利润约8647万元 同比减少3.81%
Cai Lian She· 2024-10-25 09:53AI Processing
复旦张江:前三季度净利润约8647万元 同比减少3.81% 《科创板日报》25日讯,复旦张江(01349.HK)发 布截至2024年9月30日止9个月业绩,该集团取得营业收入人民币5.49亿元,同比减少22.47%;归属于上 市公司股东的净利润8646.86万元,同比减少3.81%;基本每股收益0.08元。 ...
复旦张江:复旦张江关于召开2024年第三季度业绩说明会的公告
2024-10-18 08:44
股票代码:688505 股票简称:复旦张江 公告编号:临 2024-034 上海复旦张江生物医药股份有限公司 关于召开 2024 年第三季度业绩说明会的公告 投资者可于 2024 年 10 月 21 日(周一)至 10 月 25 日(周五)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 10 月 26 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 年第三季度报告》。为便于广大投资者全面深入地了解公司 2024 年第三季度经营成果、财务状况及发展理念,公司计划于 2024 年 10 月 28 日下 午 14:00-15:00 举行 2024 年第三季度业绩说明会,就投资者关心的问题进行交流。 一、说明会类型 本次投资者说明会以网络互动形式召开,公司将针对 2024 年第三季度的经 营成果及财务指标的具体情况与投资者进行互动交流和沟通,在信息披露允许的 范围内就投资者 ...
复旦张江:复旦张江H股公告(2)
2024-10-10 09:28
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 認購平安銀行結構性存款產品 認購結構性存款產品 近日,本公司與平安銀行訂立平安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 金向平安銀行認購金額為人民幣 2.00 億元的結構性存款產品。 上市規則的涵義 在訂立平安銀行結構性存款產品協議時,就平安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 近日,本公司與平安銀行訂立平安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 向平安銀行認購金額為人民幣 2.00 億元的結構性存款產品。 - 1 - 平安銀行結構性存款產品協議 本公司與平安銀行訂立之結構性存款產品協議的主要條款載列如下: 產品成 ...
复旦张江:复旦张江H股公告(1)
2024-10-10 09:18
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 於二零二四年十月十日,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。 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 於二零二四年十月十日,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。 上市規則的涵義 在浦發銀行結構性存款產品協議項下,實際年化收益率如下情況計算: | 觀察價 ...
复旦张江:复旦张江H股公告
2024-10-08 09:05
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 認購中國銀行結構性存款產品 認購結構性存款產品 近日,本公司與中國銀行訂立中國銀行結構性存款產品協議,同意以 A 股公開發行所得暫時閑置 募集資金向中國銀行認購金額為人民幣 1.80 億元的結構性存款產品。 上市規則的涵義 在訂立中國銀行結構性存款產品協議時,就中國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,该等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 近日,本公司與中國銀行訂立中國銀行結構性存款產品協議,同意以 A 股公開發行所得暫時閑置募 集資金向中國銀行認購金額為人民幣 1.80 億元的結構性存款產品。 - 1 - 中國銀行結構性存款產品協議 本公司與中國銀行訂立之結構性存款產品協議的主要 ...
复旦张江:复旦张江自愿披露关于注射用海姆泊芬治疗鲜红斑痣的美国Ⅱ期临床试验完成首例受试者入组的公告
2024-09-23 09:13
海姆泊芬为全球首个针对鲜红斑痣治疗的光动力药物,是集新药靶、新化合 物和新适应症于一体的新药。作为第二代光敏剂,海姆泊芬有着化合物结构稳定、 光毒作用低等特点,其用于鲜红斑痣治疗被收入人民卫生出版社《皮肤性病学》 (第九版)教科书中。海姆泊芬光动力疗法治疗鲜红斑痣具有疗效确切、病灶消 退均匀、代谢迅速、避光期短、瘢痕发生率低、治愈后极少复发等显著优势。作 为国家 1.1 类新药,注射用海姆泊芬(商品名:复美达®)已于 2017 年在中国大 上海复旦张江生物医药股份有限公司自愿披露 关于注射用海姆泊芬治疗鲜红斑痣的美国Ⅱ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")研发的用于治疗 鲜红斑痣的注射用海姆泊芬美国注册项目(即 F0026 项目)II 期临床试验近日于 美国成功完成首例受试者入组。现将相关情况公告如下: 1 / 2 股票代码:688505 股票简称:复旦张江 编号:临 2024-033 陆地区正式上市销售。2024 年上半年 ...
复旦张江:复旦张江关于参加2024年半年度制药及生物制品专场集体业绩说明会的公告
2024-09-05 08:37
股票代码:688505 股票简称:复旦张江 公告编号:临 2024-032 上海复旦张江生物医药股份有限公司 关于参加 2024 年半年度制药及生物制品专场 集体业绩说明会的公告 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 9 月 14 日(周六)16:00 前通过邮件(ir@fd-zj.com)及 电话、传真等形式将需要了解和关注的问题提前提供给公司。公司将在文字互动 环节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")已于 2024 年 8 月 13 日于上海证券交易所网站(www.sse.com.cn)披露了公司 2024 年半年度报告。 为便于广大投资者全面深入地了解公司 2024 年半年度经营成果、财务状况及发 展理念,公司参与了由上海证券交易所主办的科创板 2024 年半年度制药及生物 制品专场集体业绩说明会,此次活动将采用线上文字互动的方式举行,投资者可 登录上海证券交易所上证路演中心(http://roadshow.ssei ...
复旦张江(01349) - 2024 - 中期财报
2024-08-29 09:26
Financial Performance - 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 company's operating income for the reporting period was 408,123,863 yuan, a decrease of 21.94% from 522,827,706 yuan in the same period last year[62]. - The company reported a net profit of RMB 70,473,064 for the six months ended June 30, 2024, compared to a net profit of RMB 68,437,509 for the same period in 2023, reflecting a growth of approximately 2.99%[162]. - The sales revenue from the product Aira® decreased by 9.37% compared to the same period last year[57]. - The sales revenue from the product Liboduo® declined by 45.83% year-on-year, significantly impacting the overall revenue of the group[57]. - The sales revenue from the product 复美达® increased by 36.17% compared to the previous year[58]. Research and Development - The company's R&D expenditure accounted for 38.06% of revenue, an increase of 15.38 percentage points from 22.68% in the same period last year[7]. - The total R&D investment for the period was approximately CNY 155.33 million, representing a 30.98% increase compared to the previous period[28]. - The company filed for 17 new patents during the reporting period, with 3 patents granted, bringing the total granted patents to 96[27]. - The company has ongoing clinical trials for multiple innovative drugs, including a new compound for treating bladder cancer and a targeted therapy for triple-negative breast cancer, both at advanced stages of research[34]. - The company is committed to developing drugs that address unmet clinical needs, ensuring a balance between innovative and generic drug development[33]. - The company has made significant progress in its R&D pipeline, with several projects nearing completion of clinical trials[34]. - The company has established a nanotechnology platform aimed at enhancing drug solubility and bioavailability, with its liposomal formulation, Liboduo®, launched in August 2009[24]. Market Position and Strategy - The company operates in the biopharmaceutical sector, focusing on innovative research, development, manufacturing, and marketing[11]. - The company aims to maximize economic benefits by developing differentiated products that meet clinical needs while maintaining competitive advantages[20]. - The company is strategically focusing on expanding its market presence and enhancing its product offerings in response to competitive pressures and market dynamics[57]. - The company is exploring new sales models to address common challenges in the current marketing environment and improve patient access to treatments[36]. - The company is adopting a cautious and conservative approach to R&D expense capitalization, considering the risks and challenges associated with innovative drug development[57]. Financial Health - 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]. - Total liabilities as of June 30, 2024, were RMB 491.27 million, down from RMB 518.12 million at the end of the previous year[6]. - The company has a conservative financial policy, focusing on centralized management of funds and regular assessments of asset liquidity[68]. - The company has no significant investment or capital expenditure plans as of June 30, 2024[68]. - The company has a long-term equity investment net value of RMB 279,219,000, with a significant stake of RMB 226,503,000 in Handu Pharmaceutical, representing 7.95% of total assets[73]. Clinical Trials and Innovations - The company received approval for Phase II clinical trials for its hydrochloride amine pentanoic acid granules for breast cancer surgery visualization in January 2024[26]. - The company is conducting a Phase I clinical study for its anti-Trop2 antibody conjugate SN38 for advanced solid tumors, with results published on ASCO's website[26]. - The company has developed a range of products including cytokines, fusion proteins, monoclonal antibodies, and antibody-drug conjugates (ADCs) based on its gene engineering technology platform, which has become feasible for industrialization as the company expands[21]. - The company is advancing clinical trials for ALA granules in breast-conserving surgery for breast cancer[46]. - The company is also advancing intraoperative molecular imaging (IMI) technology for real-time tumor visualization during surgeries, which could improve surgical outcomes[42]. Corporate Governance and Compliance - The audit committee reviewed the financial statements for the six months ending June 30, 2024, and confirmed compliance with applicable accounting standards and the Hong Kong Listing Rules[109]. - The company has fully complied with the requirements for independent non-executive directors as per the Hong Kong Listing Rules during the reporting period[113]. - The company believes that having the same person serve as both Chairman and CEO is beneficial for its current stage of development, despite the deviation from the corporate governance code[111]. - The company has not purchased, sold, or redeemed any of its listed securities during the six months ending June 30, 2024[114]. Environmental Responsibility - The company invested RMB 797,700 in environmental protection during the reporting period[115]. - The company has established an environmental protection mechanism and has not faced any administrative penalties related to environmental issues during the reporting period[115]. - The company has implemented measures for air pollution control, adhering to the Shanghai industrial waste gas emission standards[115]. - The company has established a comprehensive energy-saving and water-saving performance management system, setting specific targets for each department to enhance resource utilization and reduce waste[119]. Shareholder Information - The company plans to issue a total of 38 million restricted shares under the incentive plan, representing approximately 3.67% of the total shares issued as of June 30, 2024[88]. - The board proposed an interim dividend of RMB 0.02 per share for the six months ending June 30, 2024, totaling RMB 20,731,442 based on 1,036,572,100 shares issued[69]. - The interim dividend distribution for A shares is approximately RMB 14,211,224, while for H shares it is about RMB 6,520,000[69]. - The company distributed dividends of RMB 0.05 and RMB 0.07 per share for the fiscal years ending December 31, 2020, and December 31, 2022, respectively[90].