证券代码：688192 证券简称：迪哲医药 公告编号：2025-57 迪哲（江苏）医药股份有限公司 自愿披露关于高瑞哲®和 Birelentinib 多项研究 入选第 67 届美国临床血液学会（ASH）大会的公告 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。 (1) 国际多中心注册临床研究 JACKPOT8 Part B 最新 2 年随访数据：美国单 中心分析显示，接受高瑞哲®治疗获持续缓解，疗效与耐受性与整体研究人群一 致 1 (2) 高瑞哲®作用机制研究提示，高瑞哲®单药可调节 PTCL 免疫微环境，联 合西达本胺可产生抗 PTCL 的协同增效作用 (3) 高瑞哲®回顾性研究显示，其单药或联合治疗方案针对 r/r PTCL 伴噬血 细胞性淋巴组织细胞增多症（HLH）表现出抗 HLH 和抗肿瘤双重活性，且安全 性良好 2. PTCL 一线治疗领域： 迪哲（江苏）医药股份有限公司（以下简称"公司"）将于 12 月 6 日至 9 日在第 67 届美国临床血液学会（American Society of Hematology， ...

Core Viewpoint - The company, DIZHE Pharmaceutical (688192.SH), will present significant research findings on its core lymphoma treatment products at the upcoming 67th American Society of Hematology (ASH) conference from December 6 to 9 [1] Group 1 - The company will showcase two major products: Golixtin (generic name: Golitinib capsules) and birelentinib (DZD8586) [1] - A total of 15 abstracts from the company have been accepted for presentation at the conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]

Core Viewpoint - The company, DIZHE Pharmaceutical (688192), will present multiple research findings on its key lymphoma treatment products, Golitinib (generic name: Golitinib capsules) and Birelentinib (DZD8586), at the 67th American Society of Hematology Annual Meeting from December 6 to 9 [1] Group 1 - The company has 15 abstracts accepted for presentation at the conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]

Core Viewpoint - The company, DIZHE Pharmaceutical (688192.SH), will present multiple research findings on its key lymphoma treatment products at the upcoming 67th American Society of Hematology (ASH) conference from December 6 to 9, showcasing its robust pipeline and research potential in the field of hematologic oncology [1] Group 1 - The company will unveil research results for two core products: Golitiximab (highly regarded as 高瑞哲®) and birelentinib (DZD8586) [1] - A total of 15 abstracts from the company have been accepted for presentation at the ASH conference, highlighting its extensive pipeline in blood cancer treatment [1] - The participation in this prestigious conference reflects the company's commitment to advancing research in hematologic malignancies [1]

Core Viewpoint - The company, DIZHE Pharmaceutical (688192.SH), will present significant research findings on its core lymphoma treatment products, Golixty (generic name: Golitinib capsules) and birelentinib (DZD8586), at the 67th American Society of Hematology (ASH) conference from December 6 to 9 [1] Group 1 - The company has 15 abstracts accepted for presentation at the ASH conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]

Core Insights - The company, DIZHE Pharmaceutical (688192.SH), will present multiple research findings on its core lymphoma treatment products, Golitinib (高瑞哲®) and birelentinib (DZD8586), at the 67th American Society of Hematology (ASH) conference from December 6 to 9 [1] - A total of 15 abstracts from the company have been accepted for the conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]

Group 1 - The core viewpoint of the article is that China Galaxy has given a "recommended" rating to Dize Pharmaceutical (688192.SH) based on significant developments in its product pipeline [1] - Shuwotini has received overseas approval for market launch, and multiple achievements have been selected for the 2025 WCLC [1] - The dual-target BTK has received fast track designation and is set to be showcased at the 2025 ASH [1]

Core Viewpoint - DIZHE Pharmaceuticals, established in 2017 and listed in 2021, focuses on innovative therapies for malignant tumors and has a competitive product pipeline with two products already on the market [1] Business Performance - For Q3 2025, DIZHE Pharmaceuticals reported revenue of 586 million yuan, ranking 73rd in the industry, while the industry leader, Huadong Medicine, reported revenue of 32.664 billion yuan [2] - The net profit for the same period was -583 million yuan, placing the company 109th in the industry, with the top performer, Heng Rui Medicine, achieving a net profit of 5.76 billion yuan [2] Financial Ratios - As of Q3 2025, the company's debt-to-asset ratio was 51.15%, higher than the industry average of 35.26%, but down from 73.38% year-on-year, indicating reduced debt pressure [3] - The gross profit margin stood at 95.68%, significantly above the industry average of 57.17%, despite a slight decrease from 97.73% in the previous year, reflecting strong profitability [3] Executive Compensation - Chairman and CEO Xiaolin Zhang's compensation for 2024 was 6.0572 million yuan, a decrease of 3.4776 million yuan from 2023 [4] Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 5.01% to 8,806, with an average holding of 46,500 shares, up 108.97% from the previous period [5] Revenue and Profit Forecast - According to Huatai Securities, DIZHE Pharmaceuticals is expected to achieve nearly 800 million yuan in revenue from its product Shuwotini in 2025, with a domestic peak potential of over 2 billion yuan [6] - Donghai Securities highlighted the company's strong R&D and commercialization capabilities, predicting revenues of 700 million, 1.225 billion, and 2.314 billion yuan for 2025 to 2027 [7]

Core Insights - Dize Pharmaceutical (Jiangsu) Co., Ltd. reported a revenue of 586 million yuan for the first three quarters of 2025, marking a 73% year-on-year increase [2] - The company achieved quarterly revenues of 160 million yuan, 195 million yuan, and 231 million yuan in Q1, Q2, and Q3 respectively, with a compound growth rate of 20% [2] Commercialization and Operational Efficiency - The core products, Shuwozhe® (Shuwotini tablets) and Gao Ruizhe® (Golisitinib capsules), have shown significant growth in market penetration and sales revenue, driving robust revenue growth [3] - Dize Pharmaceutical achieved commercial profitability for the first time in H1 2025, with revenues covering costs beyond R&D expenses, indicating a developing financial sustainability model [3] R&D and Product Pipeline - The company is actively expanding clinical research for its two marketed products and has entered Phase III clinical trials for its globally innovative LYN/BTK dual-target inhibitor, birelentinib, which has received Fast Track designation from the FDA [3] - Dize Pharmaceutical is focusing on non-small cell lung cancer (NSCLC), covering approximately 70% of NSCLC patients, and has made significant progress in 11 recent studies presented at the 2025 World Lung Cancer Conference [4][5] Market Potential and Future Plans - The company is targeting a potential market worth billions in the hematological malignancies sector with its core pipelines, Gao Ruizhe® and birelentinib, aimed at T-cell and B-cell lymphomas [5] - Dize Pharmaceutical's CEO highlighted the historical revenue peak driven by the commercialization of core products and emphasized the commitment to addressing unmet clinical needs while enhancing value creation capabilities [6]

Group 1 - The core viewpoint of the news is that Dize Pharmaceutical (688192.SH) has seen significant institutional investment, with 72 institutional investors holding a total of 332 million shares, representing 72.22% of the total share capital as of October 30, 2025 [1] - The top ten institutional investors collectively hold 66.66% of the shares, with a slight increase of 0.15 percentage points compared to the previous quarter [1] Group 2 - In the public fund sector, 24 funds increased their holdings, accounting for 1.45% of the total, while 27 funds decreased their holdings, representing a reduction of 0.38% [2] - Eight new public funds were disclosed this period, while 312 funds were not disclosed compared to the previous quarter [2] - One new foreign institution, Hong Kong Central Clearing Limited, was disclosed this period [2]