迪哲医药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。2025年上半年，迪哲医药在商业化方面，持续取得突破性进展。在医保赋能的推动下，旗下舒沃哲 ®（通用名：舒沃替尼片）和高瑞哲®（通用名：戈利昔替尼胶囊），销售持续放量，保持高速增长。 本报讯 （记者李亚男）8月22日晚间，迪哲（江苏）医药股份有限公司（以下简称"迪哲医药"）发布 2025半年度报告。今年上半年，公司实现营业收入3.55亿元，同比增长74.4%。实现归属于上市公司股 东的净利润-3.78亿元，同比减亏12%。 值得一提的是，今年7月份，公司核心产品之一的舒沃哲®通过优先审评在美获批上市，成为目前全球 首个且唯一获FDA批准的EGFR二十号外显子插入突变（exon20ins）非小细胞肺癌（NSCLC）国产创新 药，也是中国首个独立研发在美获批的全球首创新药。 今年以来，在核心管线研发方面，迪哲医药也开始全面提速。肺癌治疗领域，舒沃哲®用于一线治疗 EGFR exon20ins NSCLC的全球III期注册临床研究，已于今年上半年完成患者入组，有望重塑该领域全 球治疗格局。 在血液肿瘤领域，高瑞哲®和在研 ...

Core Viewpoint - The company, DIZH Pharmaceutical (688192.SH), is set to present significant research advancements on its first-in-class drugs, GoliXitini (GoliXitini Capsules) and DZD8586, at the upcoming EHA and ICML conferences, focusing on their efficacy and safety in treating hematological malignancies [1][2]. Group 1: GoliXitini Research Findings - GoliXitini is being studied for maintenance therapy in patients with peripheral T-cell lymphoma (PTCL) who have achieved remission after first-line systemic treatment, showing potential to maintain and enhance anti-tumor efficacy with manageable safety [1] - The drug has demonstrated encouraging anti-tumor efficacy and good safety in various clinical studies, including those involving first-line treatment with the CHOP regimen for PTCL and real-world studies for relapsed/refractory T-cell large granular lymphocyte leukemia (r/rT-LGLL) [1] Group 2: DZD8586 Research Findings - DZD8586 has shown an objective response rate (ORR) of 84.2% in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have previously undergone multiple treatments, including those with classic BTK resistance mutations [2] - The safety profile of DZD8586 is controllable, with no observed drug-related bleeding, atrial fibrillation, or major cardiac risks in clinical settings [2] - Latest data from a Phase II clinical study of DZD8586 as a monotherapy for relapsed/refractory diffuse large B-cell lymphoma (r/rDLBCL) will also be presented, indicating good anti-tumor efficacy and safety [2]

Core Insights - Dize Pharmaceutical achieved significant revenue growth in 2024, with operating income reaching 360 million yuan, a year-on-year increase of 294.24%, while the net profit attributable to shareholders was approximately -846 million yuan, a reduction in losses by 24% [1] - In Q1 2025, the company reported operating income of 160 million yuan, a year-on-year growth of 96.32%, with a net profit of approximately -193 million yuan, also showing a reduction in losses by 14% [1] - The company focuses on innovative therapies for malignant tumors and immune diseases, with a competitive product pipeline that includes two leading products in global clinical trials, both of which have been approved for market entry in China and included in the national medical insurance drug list [1] Financial Performance - The sales expense ratio for Q1 2025 was 77%, a significant decrease from the 124% sales expense ratio for the entire year of 2024, indicating improved operational efficiency and effective cost control [2] - The company raised a total of 1.796 billion yuan through a private placement of A-shares, with nearly 1 billion yuan allocated for the research and development of core pipeline drugs including Shuwotai and Gaoruizhe [3] Strategic Developments - The company has established a dedicated commercialization team focused on lung cancer and hematological tumor products, creating a nationwide sales network to meet the growing market demand driven by medical insurance expansion [1] - The CEO highlighted the expectation of record growth in the first year of medical insurance coverage for the two commercialized products, emphasizing the commitment to maximizing shareholder returns through efficient commercial operations [2] - Shuwotai's new drug application has been accepted by the FDA and is under priority review, with ongoing global multi-center Phase III clinical trials advancing [2]

Core Viewpoint - The company has made significant progress in the commercialization of its innovative drugs, with two products included in the National Medical Insurance Directory, leading to substantial revenue growth and reduced net losses. Financial Performance - In Q1 2025, the company achieved revenue of 160 million yuan, a year-on-year increase of 96.32% compared to Q1 2024 [5] - The company reported a net loss attributable to shareholders of 317.2 million yuan, a decrease from the previous year [5] - For the full year 2024, the company recorded sales revenue of 360 million yuan, a year-on-year increase of 294.24% [13] Product Development and Regulatory Approvals - The company's products, Shuwozhe® and Gaoruizhe®, received approval for inclusion in the National Medical Insurance Directory in November 2024, effective from January 1, 2025 [5] - Shuwozhe®'s New Drug Application (NDA) was accepted by the FDA in January 2025, with priority review status granted for treating specific types of lung cancer [6][14] - The company has made advancements in clinical research, with multiple presentations at major conferences, including the European Lung Cancer Conference and the American Society of Clinical Oncology [6][7] Research and Development - The company invested 724 million yuan in R&D in 2024, a decrease of 10.17% year-on-year, focusing on advancing clinical trials and new product development [38] - The company is developing several innovative drugs targeting various cancers, including DZD8586 and DZD6008, which are in different stages of clinical trials [19][20][21] Market and Industry Context - The global oncology drug market is expected to grow significantly, with projections of reaching 419.8 billion USD by 2030, driven by an increasing patient population and rising healthcare expenditures [27][28] - The company operates in a highly competitive and innovative sector, focusing on first-in-class and best-in-class drug development to meet unmet clinical needs [32][31]

本报讯 （记者李亚男）4月16日晚间，迪哲（江苏）医药股份有限公司（以下简称"迪哲医药"）披露向 特定对象发行A股股票发行情况报告书，公司已顺利完成本次定增事项。 发行情况报告书显示，本次定增定价基准日为发行期首日即4月1日，发行价格不低于定价基准日前20个 交易日的80%，即不低于38.10元。根据最终的申购情况，本次发行价格确定为43元/股，募集资金总额 为17.96亿元。 根据公告，共有24个认购对象参与了本次发行申购，最终按照认购价格优先、认购金额优先和收到《申 购报价单》时间优先的原则确定了最终获配发行对象共计14名，包括多家知名公募基金和保险资金为代 表的长期耐心资本，如泰康资产管理有限责任公司、朱雀基金管理有限公司、鹏华基金管理有限公司、 诺德基金管理有限公司、博时基金管理有限公司等，也有瑞士银行有限公司（UBSAG，瑞士银行）这 一合格境外机构投资者QFII，以及江苏无锡生物医药产业专项母基金（有限合伙）。 业内人士表示，本次融资获得众多知名投资者认购，充分说明市场机构投资者对迪哲医药价值和创新药 板块的中长期关注和认可。 迪哲医药相关工作人员表示："本次定增事项顺利完成，有助于公司更快地发展 ...