Core Viewpoint - Dizal Pharmaceutical Co., Ltd. is a global innovative biopharmaceutical company focusing on the research, development, and commercialization of innovative drugs for malignant tumors and autoimmune diseases, with significant advancements in its core products [1][6]. Financial Performance - For the first half of 2025, the company reported a revenue of 355 million RMB, a 74.4% increase compared to the same period last year [3][4]. - The total loss attributable to shareholders was approximately 377 million RMB, with a net loss of 419 million RMB after excluding non-recurring items [3][4]. - Research and development expenses amounted to 408 million RMB, representing 115% of the revenue [3][4]. Product Development - The company has two core products: Shuwotai (舒沃替尼片) and Gaoruizhe (高瑞哲), both of which have been approved for sale in China, with Shuwotai also receiving FDA accelerated approval in the U.S. [1][6]. - Shuwotai is the first and only EGFR Exon20ins NSCLC drug approved in the U.S. and has been included in the NCCN guidelines for non-small cell lung cancer [5][6]. - The global multi-center Phase III confirmatory clinical trial "WUKONG28" for Shuwotai has completed patient enrollment [5][6]. Research and Development Focus - The company emphasizes continuous investment in R&D, with a focus on innovative therapies for unmet clinical needs, and has established a pipeline of seven globally competitive products [6][8]. - Birelentinib (DZD8586) is a new dual-target inhibitor for B-cell non-Hodgkin lymphoma, showing promising results in clinical trials [7][8]. - DZD6008, a selective EGFR TKI, has demonstrated strong efficacy in preclinical studies and early clinical trials, particularly for patients with CNS metastases [9][10]. Market Position and Strategy - The company aims to fill unmet clinical needs with first-in-class drugs and breakthrough therapies, leveraging its advanced research capabilities and a comprehensive R&D platform [6][8]. - The commercial team is well-established, focusing on market access and academic promotion for its leading products [8].

Core Insights - Diza Pharmaceutical Co., Ltd. is a global innovative biopharmaceutical company focused on the research, development, and commercialization of innovative drugs for malignant tumors and autoimmune diseases [1][3] - The company has two core products, Shuwotai (Shuwotai Tablets) and Gaoruizhe (Gorilixitin Capsules), which have been approved for sale in China and included in the National Basic Medical Insurance [1][2] - The company has received FDA priority review approval for its new drug application for a treatment targeting adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific mutations [1] Financial Performance - As of June 30, 2025, the company reported a revenue of 355 million yuan, representing a 74.4% increase compared to the same period last year [2][4] - The company incurred a total loss of approximately 379 million yuan during the reporting period, which is an improvement from a loss of about 432 million yuan in the previous year [4] - Research and development expenses amounted to 408 million yuan, indicating a significant investment in clinical trials and product development [2][4] Company Overview - Diza Pharmaceutical is listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board under the stock code 688192 [2][3] - The total assets of the company reached approximately 3.22 billion yuan, an increase of 87.26% compared to the end of the previous year [2] - The company has not proposed any profit distribution or capital reserve transfer plans for the reporting period [2]

第二届董事会第十五次会议决议公告 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 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 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： 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，不存在虚假记载、误导性陈述或重大遗漏。 医药股份有限公司 2025 年半年度报告摘要》。 项报告>的议案》 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。 董事发言要点与主 ...

Core Viewpoint - The report highlights the significant progress and achievements of Dize (Jiangsu) Pharmaceutical Co., Ltd. in the first half of 2025, focusing on innovative drug development, sales growth, and corporate governance improvements [1][2][7]. Group 1: Product Development and Clinical Trials - The company received FDA accelerated approval for its core product, ZEGFROVY, making it the first domestically developed drug approved in the U.S. for EGFR Exon20ins NSCLC [1]. - DZD8586, a new dual-target inhibitor for B-cell non-Hodgkin lymphoma, showed an objective response rate (ORR) of 84.2% in heavily pre-treated patients [3][4]. - DZD6008, a selective EGFR TKI, demonstrated promising early clinical data in patients with EGFR-mutant NSCLC, with 83.3% of patients showing tumor shrinkage [6]. Group 2: Financial Performance - The company achieved sales revenue of 355 million yuan in the first half of 2025, representing a year-on-year growth of 74.4% [7]. Group 3: Fundraising and Investment - The company successfully completed a fundraising round, raising 1.796 billion yuan to accelerate core product development and establish a self-research production base [7]. Group 4: Corporate Governance - The company has enhanced its governance structure by implementing a new market value management system and revising internal management regulations to ensure compliance and operational efficiency [8][9]. Group 5: Investor Relations - The company emphasizes investor relations by actively communicating through various channels, including announcements and direct interactions, to enhance transparency and investor understanding of its operations [9][10].

Fundraising Overview - The company raised a total of RMB 1,986,567,781.57 from its initial public offering, verified by PwC [1] - In 2025, the company raised RMB 1,795,886,744.00 from a targeted issuance, with a net amount of RMB 1,773,446,130.53 after deducting issuance costs [2] Fund Utilization - As of June 30, 2025, the company has utilized RMB 1,641,979,531.17 of the raised funds, with RMB 4,761,963.69 remaining in the special account [3][4] - The company has engaged in cash management with temporarily idle funds amounting to RMB 415,000,000.00 [3][11] Fund Management - The company has established a management system for the raised funds, adhering to relevant laws and regulations, and has implemented a special account management approach [5] - A tripartite supervision agreement was signed with the sponsoring institution and banks to ensure proper management of the raised funds [6][7] Cash Management - The company has approved the use of idle funds for cash management, investing in safe and liquid financial products, with a maximum limit of RMB 50,000,000.00 [10] - As of June 30, 2025, the company has RMB 390,000,000.00 in cash management from the targeted issuance [14] Fund Replacement and Reallocation - The company has replaced RMB 136,542,332.57 of the initial public offering funds and RMB 2,671,312.36 from the targeted issuance with self-raised funds for project investments [16] - There were no instances of using excess funds for permanent working capital or repaying bank loans during the reporting period [15] Project Investment Status - The company has not changed the use of funds for investment projects during the reporting period and has complied with all regulations regarding fund usage [19]

Core Viewpoint - Dige Pharmaceutical (688192.SH) reported a significant increase in revenue for the first half of 2025, achieving 355 million yuan, a year-on-year growth of 74.40%, despite a net loss attributable to shareholders of 377 million yuan [1] Financial Performance - The company achieved a total revenue of 355 million yuan in the first half of 2025, marking a 74.40% increase compared to the previous year [1] - The net profit attributable to shareholders was a loss of 377 million yuan, with a basic earnings per share of -0.87 yuan [1] Research and Development - Continuous investment in research and development is identified as a key support for the company's high-quality growth, with ongoing efforts in the development of innovative drugs being a major factor influencing financial performance [1] - All products have been included in the medical insurance system, leading to a substantial increase in product sales revenue [1] - The company maintains a high level of overall R&D investment, with ongoing progress in products under development [1]

（文章来源：每日经济新闻） 迪哲医药8月22日晚间发布半年度业绩报告称，2025年上半年营业收入约3.55亿元，同比增加74.4%；归 属于上市公司股东的净利润亏损约3.77亿元；基本每股收益亏损0.87元。 ...

迪哲（江苏）医药股份有限公司 关于 2025 年度"提质增效重回报"行动方案的 半年度评估报告 为贯彻中央经济工作会议、中央金融工作会议精神，践行以投资者为本的理念， 推动上市公司持续优化经营、规范治理和积极回报投资者，迪哲（江苏）医药股份 有限公司（简称"公司"）于 2025 年 4 月 30 日发布了《关于 2024 年度"提质增效 重回报"行动方案的年度评估报告以及推动 2025 年度"提质增效重回报"行动方 案》（以下简称"《行动方案》"）。公司根据《行动方案》内容，积极开展和落 实各项工作，现将 2025 年上半年的主要工作成果评估报告如下： 一、舒沃哲®美国获批，核心产品加速前行 公司是一家创新型生物医药企业，专注于恶性肿瘤、免疫性疾病领域创新疗法 的研究、开发和商业化。公司坚持源头创新的研发理念，以推出全球首创药物 （First-in-class）和具有突破性潜力的治疗方法为目标，旨在填补全球未被满足的 临床需求。报告期内，公司持续创新研发投入，提升全球竞争力，2025 年上半年 研发投入达 4.08 亿，2025 年上半年主要产品取得了令人鼓舞的进展： 1. 舒沃哲®上市申请获美国 FDA 优 ...

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 ...