证券代码：688192 证券简称：迪哲医药 公告编号：2025-51 迪哲（江苏）医药股份有限公司 2025 年半年度募集资金存放与实际使用情况 的专项报告 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。 根据《上市公司募集资金监管规则》和《上海证券交易所科创板股票上市规则》 等有关规定，迪哲（江苏）医药股份有限公司（以下简称"迪哲医药"或"公司"） 就 2025 年半年度募集资金与实际使用情况专项报告说明如下： 一、募集资金基本情况 （一） 实际募集资金金额和资金到位时间 1. 首次公开发行股票 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），公司向社会公众首次公开发行人民币普通股（A 股） 40,000,100 股，募集资金总额为人民币 2,103,205,258.00 元，扣除发行费用后，募 集资金净额为人 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2025-50 迪哲（江苏）医药股份有限公司 第二届董事会第十五次会议决议公告 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 8 月 22 日召开公司第二届董事会第十五次会议（以下简称"会议"）。本次会议通知 于 2025 年 8 月 12 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。 二、董事会会议审议情况 全体董事对本次董事会会议议案进行了审议，经表决形成如下决议： 1. 审议通过《关于公司<2025 年半年度报告及其摘要>的议案》 2025 年半年度报告经审计委员会事前审阅，审计委员会认为：半年度报 告的编制、审议程序符合相关法律法规及规范性文件的规定和要求，报 告的内容真实、准确、完整地反映了公司报告期内的财务状况和经营成 果 ...

Financial Performance - The company reported a revenue of RMB 355 million for the first half of 2025, with a continued focus on clinical trials and research and development expenses amounting to RMB 408 million[4]. - The company's revenue for the first half of the year reached ¥355,001,420.82, representing a 74.40% increase compared to ¥203,550,120.00 in the same period last year[18]. - The total profit for the period was -¥378,990,328.00, showing an improvement from -¥432,296,836.34 year-on-year[18]. - The company reported a net cash flow from operating activities of -¥264,669,368.74, an improvement from -¥300,946,766.51 in the same period last year[18]. - The basic earnings per share for the first half of the year was -¥0.87, slightly worse than -¥0.83 in the previous year[19]. - The weighted average return on net assets was -61.52%, compared to -46.83% in the same period last year[19]. - The company’s net profit after deducting share-based payment impacts was -344.73 million RMB for the first half of 2025, compared to -366.21 million RMB in the same period last year[23]. - The net loss for the reporting period was CNY 379 million, a reduction of CNY 53 million from the same period last year[74]. - The company reported a significant increase in sales revenue from goods and services, totaling ¥346,296,077.75 in the first half of 2025, compared to ¥185,031,443.20 in the same period of 2024, reflecting improved sales performance[154]. Research and Development - The company invested 408 million RMB in R&D during the first half of 2025, focusing on core product development and clinical research[28]. - The company's R&D expenditure as a percentage of revenue was 115.00%, down from 188.05% in the previous year, indicating a strategic focus on maintaining high R&D investment[19]. - The company has achieved significant progress in its product pipeline, with all products now included in medical insurance, leading to substantial sales revenue growth[19]. - The company continues to prioritize innovation and R&D as key drivers for sustainable high-quality development[19]. - The new molecule GW5282 entered clinical research in the first half of 2025, exploring its potential applications in solid tumors and hematological malignancies[29]. - The company has established a competitive commercialization team with extensive experience in lung cancer and hematological malignancies, actively promoting its leading products[42]. - The company has developed multiple core technology platforms in translational science to enhance the success rate of new drug development[44]. - The company has seven innovative drugs in global clinical research, with Shuwozhe® approved in both China and the US, and Gao Ruizhe® approved in China[41]. Product Development and Approval - The core products, ZEGFROVY® (舒沃替尼片) and Golitinib (高瑞哲®), have been approved for sale in China and included in the National Medical Insurance Drug List for 2024[3]. - ZEGFROVY® has received priority review approval from the FDA for use in adult patients with locally advanced or metastatic non-small cell lung cancer with specific EGFR mutations[3]. - The product Shuwozhe® received accelerated approval from the FDA in July 2025 for treating adult patients with advanced or metastatic NSCLC with EGFR Exon20ins mutations[26]. - Gao Ruizhe® is the world's first and only drug targeting the JAK/STAT pathway for relapsed or refractory peripheral T-cell lymphoma (r/r PTCL), included in the national medical insurance drug list[33]. - Birelentinib shows an objective response rate (ORR) of 84.2% in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received multiple prior treatments[35]. - The expected duration of response (DoR) for Birelentinib is 83.3% at 9 months, demonstrating significant anti-tumor efficacy with good safety profile[35]. - The company has established a product pipeline with seven globally competitive products, including Shuwozhe® and Huoruizhe®[26]. - Shuwozhe® has received recognition in international academic circles, with data presented at major conferences such as the World Lung Cancer Conference[32]. Financial Position and Assets - The total assets rose by 87.26% to ¥3,218,460,585.31 compared to ¥1,718,737,884.05 at the end of the previous year[18]. - The net assets attributable to shareholders increased significantly by 738.25% to ¥1,624,158,702.71 from ¥193,755,800.40 at the end of the previous year[18]. - The company’s cash and cash equivalents increased by 397.50% to CNY 1.245 billion, primarily due to funds raised from issuing shares[79]. - The company’s trading financial assets rose by 70.58% to CNY 1.006 billion, reflecting the investment of idle funds in structured deposits[79]. - The accounts receivable increased by 198.74% to CNY 82 million, driven by the growth in product sales revenue[79]. - Total current assets increased to CNY 2,404,927,026.78 as of June 30, 2025, compared to CNY 998,972,803.78 on December 31, 2024, representing a growth of approximately 141%[139]. - Cash and cash equivalents reached CNY 1,244,565,866.20, up from CNY 250,164,742.63, indicating a significant increase of 397%[139]. - Total liabilities amounted to CNY 1,589,683,059.97, up from CNY 1,518,680,986.42, showing an increase of about 4.4%[141]. Risks and Challenges - The company has not yet achieved profitability and continues to face cumulative losses[4]. - The company faces risks related to the approval process of new drugs, which may not meet expectations, potentially delaying commercialization and impacting business operations[61]. - The dynamic adjustment mechanism of the national medical insurance drug list poses a risk, as products could be removed from the list, affecting market share and revenue[72]. - The company is exposed to risks from rising costs of R&D services and materials, which could impact operational efficiency and profitability[66]. - The company must adapt to regulatory changes in the pharmaceutical industry to avoid negative impacts on its operations and market positioning[69]. - The company is currently in the early commercialization phase and has not yet achieved profitability, with ongoing significant R&D expenditures expected to continue[55]. - The company is focusing on accelerating the clinical research of its product pipeline to ensure sustainable development and address market uncertainties[55]. Shareholder and Equity Information - The total number of shares increased from 417,648,086 to 459,412,894, reflecting an increase of 41,764,808 shares, which is approximately a 10% increase[120]. - The proportion of shares held by domestic non-state-owned legal persons decreased from 39.836% to 31.580%, a reduction of approximately 8.256%[119]. - The total number of circulating shares increased from 129,262,900 to 186,714,700, an increase of 57,451,800 shares, which is approximately a 44.4% increase[120]. - The company has a total of 288,385,117 shares with restricted trading rights, which is 59.358% of the total shares[119]. - The company has a commitment that shareholders will not reduce their holdings of shares issued before the IPO until the company achieves profitability[129]. - The total number of common shareholders as of the end of the reporting period is 8,386[124]. - The top ten shareholders hold a total of 288,385,117 shares, representing 57,451,788 shares with limited sale conditions[126]. - The company has not declared any cash dividends in the last three audited fiscal years due to losses, impacting the first major shareholder's ability to reduce their holdings through public trading[130]. Governance and Compliance - The company has made commitments to governance and conflict of interest prevention, with specific details available in the prospectus[91]. - The company has outlined measures to standardize and reduce related party transactions, as referenced in the prospectus[91]. - The company has confirmed that the content of the prospectus is true, accurate, and complete, with no false records[92]. - The company has committed to measures to protect investor rights as outlined in the prospectus[92]. - The company has not reported any significant commitments or changes in commitments during the reporting period[90]. - There were no acquisitions or disposals of subsidiaries reported during the period[84]. - The company has not undergone any changes in its controlling shareholder or actual controller during the reporting period[135].

迪哲医药公告，2025年上半年营业收入3.55亿元，同比增长74.40%。归属于上市公司股东的净亏损3.77 亿元，上年同期净亏损3.45亿元。 ...

Group 1 - The latest stock price of Dize Pharmaceutical-U is 82.21 yuan, an increase of 0.24 yuan from the previous trading day, with a trading range of 80.23 to 83.00 yuan and a total transaction amount of 2.31 billion yuan [1] - Dize Pharmaceutical is part of the chemical pharmaceutical sector, focusing on the research and development of innovative drugs, including the globally first high-selective JAK1 inhibitor Golixitinib and LYN/BTK dual-target inhibitors [1] - Research reports indicate that there are significant investment opportunities in the field of hematological malignancies, suggesting attention to Dize Pharmaceutical and other innovative drug companies making progress in overcoming treatment bottlenecks [1] Group 2 - The report highlights a trend in hematological malignancy treatment towards chronic disease management, driven by emerging therapeutic methods such as targeted therapy, immunotherapy, and cell therapy [1] - In terms of capital flow, Dize Pharmaceutical-U experienced a net outflow of 9.2879 million yuan on the day, with a cumulative net outflow of 81.0427 million yuan over the past five days [1]

Group 1 - The complexity of hematological tumors presents numerous investment opportunities in various subtypes of treatment [1] - The market for hematological tumors is expanding due to innovative therapies, with significant product launches expected [1] - The number of long-term patients is increasing, with approximately 4 million patients globally having survived five years or more as of 2022, which is three times the number of new patients [1] Group 2 - Future development directions for hematological tumor treatment include improving efficacy, reducing recurrence, and optimizing administration [2] - Acute leukemias like AML and ALL primarily use chemotherapy or targeted combination therapies to enhance survival rates [2] - CAR-T therapy shows high remission rates for aggressive lymphomas and multiple myeloma, providing more treatment options for patients [2] Group 3 - The competition in the targeted drug market for hematological tumors has entered a new phase, with a focus on technological iterations and exploration of new targets [3] - In the BTK field, new products are emerging to compete in the post-resistance market, with Zebutinib outperforming Ibrutinib [3] - The BCL-2 domain is seeing advancements with differentiated designs and optimized dosing strategies to gain competitive advantages [3]

Investment Rating - The report maintains a "Buy" rating for the blood cancer drug industry [3][6]. Core Insights - The blood cancer market is expanding due to innovative therapies, with significant advancements in precision diagnosis, prognosis stratification, and targeted therapies such as CAR-T and TCE, leading to improved patient survival and quality of life [5][8]. - The number of patients with blood cancer who have survived for five years or more is approximately 4 million globally, which is three times the number of new patients, indicating a growing market for long-term treatments [5][13]. - The high cost of blood cancer drugs and the emergence of blockbuster products are driving market growth, with several drugs expected to exceed $10 billion in sales by 2024 [5][17]. Summary by Sections 1. Blood Cancer Market Expansion - The proportion of new blood cancer patients is less than 10% of all new cancer cases, with a steady increase in incidence rates [8]. - Blood cancer patients have a long survival period, resulting in a large population of existing patients [13]. - The high cost of blood cancer treatments contributes to the frequent emergence of blockbuster drugs [17]. 2. Clinical Diagnosis and Treatment of Blood Cancer - Blood cancers are classified based on cell origin, differentiation, and affected sites, including leukemia, lymphoma, and multiple myeloma [19][20]. - Treatment for acute leukemia primarily involves chemotherapy or targeted combination therapies to improve survival rates [24]. - Lymphoma treatment varies by subtype, with Rituximab being a cornerstone therapy [23]. - Multiple myeloma treatment focuses on CD38 monoclonal antibodies, with ongoing exploration of solutions for relapsed and refractory cases [23]. 3. Analysis of Popular Targets and Therapies - The BTK field is seeing intense competition, with new products emerging to address resistance issues [5]. - The BCL-2 area is advancing with differentiated designs and optimized dosing strategies [5]. - The BCR-ABL TKI domain is witnessing the introduction of third-generation inhibitors that show superior efficacy [5]. 4. Company Profiles - BeiGene is focusing on a comprehensive product matrix to cover CLL/SLL indications [5]. - Innovent Biologics is building a diversified product portfolio centered around Oubreti [5]. - Ascentage Pharma is developing third-generation BCR-ABL inhibitors and BCL-2 inhibitors to create competitive advantages [5]. - Diligent Pharma is innovating with a globally first high-selectivity JAK1 inhibitor and a dual-target LYN/BTK inhibitor [5]. 5. Investment Recommendations - The blood cancer sector presents numerous investment opportunities due to its complexity and the variety of treatment subfields [5]. - The long survival cycle of blood cancer patients and the high costs of drug treatments indicate a significant market potential [5].

Group 1 - The chemical pharmaceutical sector increased by 2.34% on August 13, with Shouyao Holdings leading the gains [1] - The Shanghai Composite Index closed at 3683.46, up 0.48%, while the Shenzhen Component Index closed at 11551.36, up 1.76% [1] - Notable gainers in the chemical pharmaceutical sector included Shouyao Holdings, which rose by 19.99% to a closing price of 55.94, and Weichip Bio, which increased by 14.39% to 41.18 [1] Group 2 - The chemical pharmaceutical sector saw a net inflow of 342 million yuan from main funds, while retail investors contributed a net inflow of 426 million yuan [2] - Major stocks with significant net inflows included Heng Rui Pharmaceutical with 55.1 million yuan and Fu Xing Pharmaceutical with 23.4 million yuan [3] - Conversely, stocks like ST Sailong and ST Suwu experienced notable net outflows of 4.97% and 3.70%, respectively [2]

Group 1 - The A-share market is experiencing a surge in the pharmaceutical sector, particularly in innovative drugs, with Hai Si Ke reaching its daily limit and Di Zhe Pharmaceutical rising over 8% [1] - The National Healthcare Security Administration has announced the preliminary review of 121 drug names for inclusion in the commercial insurance innovative drug directory, including high-priced CAR-T cancer drugs [1] - The medical sector is seeing a rebound driven by CXO, with the largest medical ETF (512170) hitting a 1.9% increase, and major stocks like Zhaoyan New Drug rising over 8% [3] Group 2 - A new action plan for the high-quality development of "Artificial Intelligence + Healthcare" in Zhejiang Province has been released, focusing on creating multimodal medical industry models and specialized healthcare models [5] - Recent institutional insights suggest that the pharmaceutical sector, led by innovative drugs, is viewed positively for long-term investment, while medical devices are also gaining attention [5] - The largest medical ETF (512170) focuses on medical devices (52%) and medical services (40%), with a strong correlation to AI healthcare, covering six leading CXO stocks [6]

Group 1 - The National Medical Insurance Administration has approved 534 drugs for the basic medical insurance drug list, a significant increase compared to 2024, and established a new commercial insurance innovative drug list with 121 drugs [4] - The biopharmaceutical ETF (159839) has seen a strong performance, with a 2.53% increase on August 13, 2025, and a 1-month cumulative increase of 8.26% [1][4] - Leveraged funds are actively investing in the biopharmaceutical sector, with the latest financing buy amount reaching 2.34 million yuan and a financing balance of 12.62 million yuan [4] Group 2 - The biopharmaceutical ETF has experienced a significant increase in shares, with a growth of 6 million shares over the past year, ranking in the top third among comparable funds [3] - The biopharmaceutical sector remains a key focus in the pharmaceutical industry, with ongoing significant business development (BD) transactions that enhance resource integration and project development [5] - Recent global transactions in innovative drugs indicate a vibrant market, with six key transactions reported, reflecting the active collaboration between domestic and international companies [4]