迪哲（江苏）医药股份有限公司2025 年半年度报告 公司代码：688192 公司简称：迪哲医药 迪哲（江苏）医药股份有限公司 2025 年半年度报告 1 / 153 迪哲（江苏）医药股份有限公司2025 年半年度报告 重要提示 一、 本公司董事会及董事、高级管理人员保证半年度报告内容的真实性、准确性、完整性，不 存在虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 公司是一家全球创新型生物医药企业，专注于恶性肿瘤和自身免疫性疾病领域创新药的研究、 开发及商业化，采用科创板第五套标准上市。公司两款核心产品舒沃哲®（通用名：舒沃替尼片）、 高瑞哲®（通用名：戈利昔替尼胶囊）已在国内获批上市，并首次纳入《国家基本医疗保险、工伤 保险和生育保险药品目录（2024 年）》（国家医保药品目录）。此外，舒沃哲®（ZEGFROVY®） 通过美国食品药品监督管理局（FDA）新药上市申请（New Drug Application，NDA）优先审评批 准上市，用于既往经含铂化疗治疗时或治疗后出现疾病进展，并且经 FDA 批准的试剂盒检测确认， 存在表皮生长因子受体（EGFR）20 号外显子插入突变（Exon20ins） ...

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]

中国银河（601881）证券发布研报称，血液肿瘤分类复杂，多种细分亚型治疗领域仍存在较多投资机 会。近年来在靶向、免疫以及细胞治疗等新兴治疗手段的推广应用下，血液瘤治疗已呈现与高血压、糖 尿病类似的慢病管理趋势。血液瘤的长生存周期带来大量存量患者，且药物治疗费用高，导致重磅产品 频出，潜在市场机会巨大。建议关注百济神州(06160)、诺诚健华(09969)、亚盛医药-B(06855)、迪哲医 药-U(688192.SH)。 AML、ALL等急性白血病目前主要采用化疗或靶向联合化疗模式，并通过靶向治疗和多药联合提升生 存率。在慢性白血病治疗中，CML主要采用BCR-ABLTKI治疗，尝试通过技术迭代及新靶点克服耐 药;CLL治疗包括BTK、BCL-2、CD20等药物，正探索BTK+BCL-2固定疗程给药及开发非共价BTK、双 靶BTK、BTKPROTAC等布局BTK耐药后市场。淋巴瘤亚型较多，大多数采用利妥昔联合化疗，而多发 性骨髓瘤仍以CD38单抗治疗为核心;淋巴瘤中侵袭性较强的DLBCL和多发性骨髓瘤均面临复发概率高且 复发后难治的问题，目前CAR-T疗法缓解率较高，为后线患者提供更多治疗选择。 靶向药竞争 ...

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]

Group 1 - The core viewpoint of the article highlights the increasing interest and participation of public funds in A-share companies' private placement projects, with significant floating profits reported [1][2][4] - As of August 11, 2023, 24 public institutions participated in 48 private placement projects, with a total allocation amounting to 14.383 billion yuan and a floating profit exceeding 5 billion yuan, representing a floating profit ratio of 34.86% [2][4] - Notably, 47 out of the 48 companies involved in these private placements achieved floating profits, with some projects like Leshan Electric Power showing a floating profit ratio as high as 181.84% [2][3] Group 2 - The sectors with high floating profit ratios from private placements include electricity, machinery, public utilities, electronics, and defense [3] - Nord Fund and Caitong Fund are the most active public institutions in private placements this year, with floating profits of 1.872 billion yuan and 1.709 billion yuan, respectively [4] - The investment strategy emphasizes the importance of individual stock growth returns and the need for a balanced portfolio across industries and companies [6][7] Group 3 - The article discusses the emergence of new investment strategies such as inquiry transfer, which has shown significant growth in both quantity and value, surpassing the total issuance of competitive private placements [7][8] - Inquiry transfer is currently applicable only to the Sci-Tech Innovation Board and the Growth Enterprise Market, indicating a trend towards more innovative investment opportunities [7] - The article suggests that while private placement investments can be effective, they require thorough research on the underlying companies and their industry dynamics [8]

Group 1 - The core viewpoint of the articles highlights the increasing interest and participation of public funds in A-share companies' private placement projects, with significant floating profits reported [1][2][3] - As of August 11, 2023, 24 public institutions participated in 48 A-share companies' private placements, with a total allocation amount of 14.383 billion yuan and a floating profit exceeding 5 billion yuan, representing a floating profit ratio of 34.86% [1][2] - Notably, 47 out of the 48 companies involved in these private placements achieved floating profits, with some companies like Leshan Electric Power and Jinghua New Materials showing floating profit ratios of 181.84% and 158.04% respectively [2][3] Group 2 - The data indicates that the highest floating profit ratios were observed in sectors such as electricity, machinery, public utilities, electronics, and defense, with significant allocations in companies like Haohua Technology and Chip Origin [2][3] - Nord Fund and Caitong Fund emerged as the most active public institutions in participating in private placements, with floating profits of 1.872 billion yuan and 1.709 billion yuan respectively [2][3] - Investment strategies have shifted towards focusing on individual stock growth returns, with an emphasis on the importance of fundamental research and reasonable pricing strategies for private placements [3][4] Group 3 - The articles also discuss the rising trend of inquiry transfer as a new investment direction, which has shown significant growth in both transfer quantity and amount, surpassing the total of competitive private placements [4][5] - The inquiry transfer mechanism, similar to private placements, is expected to provide new investment opportunities, particularly in the Sci-Tech Innovation Board and the Growth Enterprise Market [4][5] - Overall, the current market environment presents favorable investment opportunities in private placements, with a focus on selecting quality stocks to enhance returns [3][4]