证券代码：688192 证券简称：迪哲医药 公告编号：2025-20 迪哲（江苏）医药股份有限公司 第二届董事会第十三次会议决议公告 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。 一、董事会会议召开情况 迪哲（江苏）医药股份有限公司（以下简称"公司"）董事会于 2025 年 4 月 29 日召开公司第二届董事会第十三次会议（以下简称"会议"）。本次会议通知 于 2025 年 4 月 18 日以邮件方式送达董事。本次会议应到董事 7 人，实到董事 7 人。会议的召集、召开程序以及召开方式符合相关法律法规以及《迪哲（江苏） 医药股份有限公司公司章程》的规定，会议决议合法、有效。 董事发言要点与主要意见：无异议。 表决结果：同意 7 票，反对 0 票，弃权 0 票。 此议案尚需提交公司股东大会审议。 具体内容详见公司刊登于上海证券交易所网站（www.sse.com.cn）的 《迪哲（江苏）医药股份有限公司 2024 年年度报告》和《迪哲（江苏） 医药股份有限公司 2024 年年度报告摘要》。 2. 审议通过《关于公司<2024 ...

Financial Performance - The company achieved a sales revenue of 360 million RMB, representing a year-on-year growth of 294.24% compared to 2023[3]. - The company's revenue for 2024 reached ¥359,900,621.06, representing a 294.24% increase compared to ¥91,288,640.00 in 2023[24]. - The net profit attributable to shareholders for 2024 was -¥845,956,285.93, an improvement from -¥1,107,713,253.26 in 2023[24]. - The net profit attributable to shareholders after deducting non-recurring gains and losses for 2024 was -¥898,889,978.56, compared to -¥1,160,727,128.66 in 2023[24]. - The net cash flow from operating activities for 2024 was -¥650,525,464.27, an improvement from -¥967,882,951.13 in 2023[24]. - The total assets as of the end of 2024 were ¥1,718,737,884.05, a 14.86% increase from ¥1,496,378,567.44 at the end of 2023[24]. - The net assets attributable to shareholders decreased by 77.17% to ¥193,755,800.40 at the end of 2024 from ¥848,627,415.80 at the end of 2023[24]. - The company reported a net profit attributable to shareholders of -224.23 million yuan in Q1 2024, with a total of -287.50 million yuan in Q4 2024[29]. - The net cash flow from operating activities was negative, totaling -126.07 million yuan in Q1 2024 and -187.22 million yuan in Q4 2024[29]. - The company reported a significant increase in production and sales volume of anti-tumor drugs, with sales volume rising by 302.3% year-on-year[101]. - The company reported a significant increase in revenue, achieving a total of 1.2 billion RMB, representing a 25% year-over-year growth[163]. Research and Development - R&D expenses reached 724 million RMB during the reporting period, reflecting the company's ongoing investment in clinical trials[5]. - The company is focused on innovative drug research and development in the fields of malignant tumors and autoimmune diseases[3]. - The company has established a product pipeline with seven globally competitive products, including two in global registration clinical trials[38]. - The company invested CNY 724 million in R&D during the reporting period, with ongoing clinical trials for Shuwozhe® and DZD8586 progressing efficiently[42]. - The company has made significant progress in R&D, with a focus on addressing unmet needs in drug development, particularly in oncology[64]. - The company has established a comprehensive R&D platform covering all stages from drug discovery to clinical development, enhancing its core competitiveness in the pharmaceutical industry[76]. - The company has a total of 267 R&D personnel, accounting for 31.34% of the total workforce, with an average salary of 76.53 thousand RMB[75]. - The company has received 73 new intellectual property rights this year, bringing the total to 336[67]. - The company has developed new technologies and models to address drug resistance in targeted therapies, including next-generation TKIs and immune checkpoint inhibitors[64]. - The company is focusing on maintaining a strong R&D investment strategy to support the development of innovative therapies[125]. Product Development and Approvals - The self-developed Class I new drug, Gorizhe® (generic name: Golixitinib capsules), was approved for marketing in China, being the world's first and only highly selective JAK1 inhibitor for r/r PTCL[4]. - The commercialized products Shuwozhe® (generic name: Shuwotini tablets) and Gorizhe® were included in the National Medical Insurance Drug List for 2024[4]. - The FDA accepted the New Drug Application for Shuwozhe® and granted it priority review status for specific NSCLC patients[4]. - The company’s leading product, Gao Ruizhe®, received approval for market launch in June 2024, addressing a significant unmet clinical need in the treatment of r/r PTCL[38]. - Shuwozhe® has submitted a New Drug Application (NDA) to the FDA for the treatment of EGFR Exon20ins NSCLC, receiving priority review status based on positive results from the global clinical study "WU-KONG1B" and has been recognized as a breakthrough therapy in both China and the U.S.[40]. - Both Shuwozhe® and Gao Ruizhe® have been included in the national medical insurance drug list, effective January 1, 2025, which is expected to accelerate commercialization[41]. Market Strategy and Expansion - The company plans to expand its commercialization team and increase promotional efforts to capture a larger market share[5]. - The company is focused on expanding its market presence and developing new products and technologies[18]. - The company is actively communicating with overseas drug regulatory agencies to accelerate the overseas market entry of its products[54]. - The company aims to fill unmet clinical needs with innovative therapies in oncology and immune diseases, focusing on first-in-class drug development[38]. - The company is currently not profitable, primarily due to significant R&D investments and the early stage of commercialization, with a cumulative loss expected to increase[78]. - The company is exploring potential mergers and acquisitions to further enhance its market position, as indicated by the strategic share allocations for senior management[156]. Governance and Management - The company is committed to enhancing its governance structure by establishing specialized committees under the board, including a strategy committee and an audit committee[149]. - The board of directors consists of 7 members, including 4 independent directors, and has held 6 meetings during the reporting period, ensuring effective governance[149]. - The supervisory board comprises 3 members, with 2 employee supervisors, and has convened 5 meetings, fulfilling its supervisory responsibilities[150]. - The company has implemented a competitive compensation system and transparent promotion pathways to attract and retain talent[143]. - The company emphasizes a "shareholder-centric" development philosophy, aiming to improve internal management efficiency and enhance the quality of the listed company[146]. - The financial director has a strong background in investment banking and has held key positions in major financial institutions, which may improve the company's financial strategies[158]. Risks and Challenges - The company has outlined various risk factors in its annual report that may impact its operations[6]. - The approval process for new drugs is uncertain, and delays could adversely affect the company's business operations[84]. - The company is exposed to risks from market competition, particularly from larger multinational and domestic companies with more extensive commercialization experience[88]. - The company faces risks related to the quality control of drug production, which could significantly impact its market reputation and operational performance[87]. - The company relies on external financing for operational funding, and any shortfall could pressure its financial situation and delay R&D projects[90]. Employee and Training Initiatives - The workforce has grown to 852 employees, a 46.64% increase year-over-year, reflecting the company's commitment to talent development and enhancing core competitiveness[43]. - Over 350 employees participated in various training programs in 2024, achieving a satisfaction rate of 95%[185]. - More than 90% of middle and senior management have completed the "Excellence Management Advancement Program," enhancing management skills and team efficiency[184]. - The company has a comprehensive training system covering compliance, safety, and professional skills, ensuring 100% coverage of occupational health and safety training[184].

Financial Performance - The company's operating revenue for Q1 2025 reached ¥159,641,464.34, representing a 96.32% increase compared to ¥81,318,560.00 in the same period last year[4] - The net loss attributable to shareholders was ¥192,513,348.95, an improvement from a loss of ¥224,234,890.87 year-over-year[4] - The total operating revenue for Q1 2025 was CNY 159,641,464.34, a significant increase from CNY 81,318,560.00 in Q1 2024, representing a growth of approximately 96%[19] - The net loss for Q1 2025 was CNY 193,740,729.91, an improvement from a net loss of CNY 224,234,890.87 in Q1 2024, reflecting a reduction in losses of approximately 14%[20] - The basic and diluted earnings per share for Q1 2025 were both CNY -0.46, compared to CNY -0.54 in Q1 2024, showing an improvement in earnings per share[21] Research and Development - Research and development expenses totaled ¥210,333,356.42, a slight increase of 2.72% from ¥204,770,425.91 in the previous year[5] - The ratio of R&D expenses to operating revenue decreased to 131.75%, down from 251.81% in the previous year, indicating a significant increase in revenue[5] - Research and development expenses for Q1 2025 were CNY 210,333,356.42, slightly up from CNY 204,770,425.91 in Q1 2024, showing a year-over-year increase of about 2%[20] - The new drug application for Shuwozhe® has been accepted by the FDA with priority review designation for specific lung cancer patients[12] - The company’s new molecule GW5282 has been approved to commence Phase I clinical trials in China[13] - DZD8586's latest clinical data has been selected for oral presentation at the 2025 ASCO conference, highlighting its significance in chronic lymphocytic leukemia treatment[13] Assets and Liabilities - Total assets at the end of the reporting period were ¥1,804,839,457.76, reflecting a 5.01% increase from ¥1,718,737,884.05 at the end of the previous year[5] - Total current assets reached RMB 1.02 billion as of March 31, 2025, compared to RMB 998.97 million at the end of 2024[16] - The total non-current assets were CNY 784,132,605.39, up from CNY 719,765,080.27, reflecting an increase of approximately 9%[18] - Total liabilities increased to CNY 1,781,305,350.81 from CNY 1,518,680,986.42, representing a growth of about 17%[18] - The equity attributable to shareholders decreased by 90.47% to ¥18,460,390.68 from ¥193,755,800.40 at the end of the previous year[5] - The company's total equity decreased to CNY 23,534,106.95 from CNY 200,056,897.63, indicating a decline of about 88%[18] Cash Flow - The company reported a net cash flow from operating activities of -¥131,666,959.46, slightly worse than -¥126,071,888.78 in the previous year[4] - The company's cash flow from operating activities for Q1 2025 was CNY 164,190,860.93, compared to CNY 96,462,224.00 in Q1 2024, indicating a substantial increase in cash inflow[23] - Net cash flow from operating activities was -$131.67 million, compared to -$126.07 million in the previous period, indicating a slight increase in cash outflow[24] - Cash inflow from operating activities totaled $189.48 million, up from $125.11 million, indicating a growth of about 51.5%[24] - Total cash inflow from investment activities was $732.18 million, down from $1.03 billion in the previous period, reflecting a decrease of approximately 29%[24] - Cash outflow for investment activities totaled $860.83 million, compared to $1.09 billion previously, showing a reduction of about 21%[24] - Net cash flow from financing activities was $262.62 million, an increase from $207.57 million in the prior period, representing a growth of approximately 26.5%[25] Government Support - The company received government subsidies amounting to ¥23,396,000.00, which are closely related to its normal business operations[6] Inventory and Assets - The company’s inventory decreased to RMB 37.54 million as of March 31, 2025, down from RMB 44.11 million at the end of 2024[16] - The company’s long-term assets include fixed assets valued at RMB 19.74 million and intangible assets valued at RMB 421.38 million as of March 31, 2025[16] - The company’s cash and cash equivalents amounted to RMB 252.51 million as of March 31, 2025, slightly up from RMB 250.16 million at the end of 2024[16]

华泰联合证券有限责任公司 关于迪哲（江苏）医药股份有限公司 2024 年度募集资金存放与使用情况的核查意见 华泰联合证券有限责任公司（以下简称"华泰联合证券"或"保荐机构"） 作为迪哲（江苏）医药股份有限公司（以下简称"迪哲医药"或"公司"）2023 年度向特定对象发行股票的保荐机构，承接公司首次公开发行的原保荐机构中信 证券股份有限公司未完成的持续督导工作，根据《证券发行上市保荐业务管理办 法》《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》等法律法规的规定，对迪哲医药在2024年度募 集资金存放与使用情况进行了审慎核查，核查情况及核查意见如下： 一、募集资金基本情况 根据中国证券监督管理委员会出具的《关于同意迪哲（江苏）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[2021]3494号）以及上海证券交 易所出具的《关于迪哲（江苏）医药股份有限公司人民币普通股股票科创板上市 交易的通知》（[2021]468号），公司已向社会公众首次公开发行人民币普通股 （A股）40,000, ...

迪哲(江苏)医药股份有限公司 鉴证报告 截至 2025 年 4 月 18 日 立信会计师事务所(特殊普通合伙) DO CHINA SHU LUN PAN CERTIFIED PUBLIC ACCOUNTANTS LLP 关于迪哲(江苏)医药股份有限公司 以募集资金置换预先投入募投项目及 已支付发行费用的自筹资金的鉴证报告 您可使用手机"扫一扫"或进入"注册会计师行业统一监管平台（http://ac.mof.eov.cn）"进行变 您可使用手机"扫一扫"或进入"注册会计师行业统一监管平台（http://ac.mo6.eov.co）"进行变 信会师报字[2025]第ZA10728号 迪哲(江苏)医药股份有限公司董事会: 我们鉴证了后附的迪哲(江苏)医药股份有限公司(以下简称贵 公司）管理层编制的截至2025年4月18日《迪哲（江苏）医药股份有 限公司以募集资金置换预先投入募投项目及已支付发行费用的自筹 资金的专项说明》。 一、管理层的责任 贵公司管理层的责任是提供真实、合法、完整的相关资料,按照 《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(2022年修订)》(证监会公告(2022)15 ...

华泰联合证券有限责任公司 关于迪哲（江苏）医药股份有限公司 使用募集资金置换预先投入募投项目 及已支付发行费用的自筹资金的核查意见 华泰联合证券有限责任公司（以下简称"华泰联合"、"保荐机构"）作为迪 哲（江苏）医药股份有限公司（以下简称"迪哲医药"或"公司"）2023 年度向 特定对象发行 A 股股票的保荐机构，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》以及《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》等相关规定履行持续督导职责，对迪哲医药使用 募集资金置换预先投入募投项目及已支付发行费用的自筹资金事项进行了核查， 核查的具体情况如下： 一、募集资金基本情况 经中国证券监督管理委员会《关于同意迪哲（江苏）医药股份有限公司向特 定对象发行股票注册的批复》（证监许可〔2025〕171 号）同意注册，公司向特 定对象发行人民币普通股（A 股）41,764,808 股，发行价格为人民币 43.00 元/ 股 ， 募 集 资 金 总 额 为 人 民 币 1,795,886,744.00 元 ， 扣 除 发 行 费 用 人 民 币 22,440,613.47 元（ ...

迪哲(江苏)医药股份有限公司 营业收入扣除情况表的鉴证报告 2024 年度 二、注册会计师的责任 您可使用手机"扫一扫"或进入"注册会计师行业统一监管平台（http://acc.mof.gov.cn） 立信会计师事务所(特殊普通合伙) do china shu lun pan certified public accountants LL 关于迪哲(江苏)医药股份有限公司2024年度 营业收入扣除情况表的鉴证报告 信会师报字[2025]第ZA12222号 迪哲(江苏)医药股份有限公司全体股东: 我们审计了迪哲(江苏)医药股份有限公司(以下简称"迪哲医 药")2024年度的财务报表,包括 2024年 12月 31日的合并及母公司 资产负债表、2024 年度合并及母公司利润表、合并及母公司现金流 量表、合并及母公司所有者权益变动表和相关财务报表附注,并于 2025 年 4 月 29 日出具了报告号为信会师报字[2025]第 ZA12218 号的 无保留意见审计报告。 在对上述财务报表执行审计的基础上,我们接受委托,对后附的 迪哲医药2024年度营业收入扣除情况表(以下简称"营业收入扣除情 况表")执行了合理保证的 ...

华泰联合证券有限责任公司 关于迪哲（江苏）医药股份有限公司 调整募集资金投资项目拟投入募集资金金额的核查意见 华泰联合证券有限责任公司（以下简称"华泰联合"、"保荐机构"）作为迪 哲（江苏）医药股份有限公司（以下简称"迪哲医药"或"公司"）2023 年度向 特定对象发行 A 股股票的保荐机构，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》以及《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》等相关规定履行持续督导职责，对迪哲医药调整 募集资金投资项目拟投入募集资金金额事项进行了核查，核查的具体情况如下： 一、募集资金基本情况 经中国证券监督管理委员会《关于同意迪哲（江苏）医药股份有限公司向 特定对象发行股票注册的批复》（证监许可〔2025〕171号）同意注册，公司向 特定对象发行人民币普通股（A股）41,764,808股，发行价格为人民币43.00元/ 股 ， 募 集 资 金 总 额 为 人 民 币 1,795,886,744.00 元 ， 扣 除 发 行 费 用 人 民 币 22,440,613.47元（不含增值税），公司本次实际募集资金净额为人民币 1,773 ...