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 ...

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： ZEGFROVY ）的新药上市申请（New ...

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]

作为全球源头创新的研发公司，持续的研发投入是公司实现高质量发展的关键支撑，因此对于创新药的 持续研发投入是公司经营财务状况的主要因素之一。本报告期公司产品均已纳入医保，产品销售收入大 幅增长，实现产品合计销售收入3.55亿元；随着商业化进程的推进，产品销售收入将成为影响公司经营 财务状况的主要因素，同时公司在研产品方面取得了持续进展，整体研发投入仍维持在较高水平。 格隆汇8月22日丨迪哲医药(688192.SH)公布2025年半年度报告，上半年实现营业收入3.55亿元，同比增 长74.40%；归属于上市公司股东的净利润-3.77亿元；基本每股收益-0.87元。 ...

（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 ...