事件 公司发布2025 半年度报告，上半年实现营业收入3.55 亿元（+74%），净亏损收窄至3.79 亿元，销售费 用率76%（-24pts），现金及现金等价物达22.51 亿元（+172%）。医保赋能双产品快速放量，商业化收 入增长强劲，亏损进一步缩窄。 核心观点 舒沃替尼一线全球III 期入组完成，临床与适应症拓展双线并进舒沃替尼作为全球首个口服EGFR Exon20ins 抑制剂，不仅在中国和美国获批，还成功进入NCCN 推荐，显示出全球临床价值。其一线全 球III 期注册研究已完成入组，并同步拓展耐药NSCLC 及其他适应症领域，最新数据将在2025 WCLC 披露，注册与适应症拓展齐头并进。 高瑞哲疗效显著，积极推进联用实验 高瑞哲在r/r PTCL 治疗中获CSCO 指南I 级推荐，单药治疗r/r NKTCL首次获得推荐，针对PTCL 维持治 疗获得认可，凭借优异疗效，有望在全球PTCL 市场形成领先优势。同时，公司积极推进高瑞哲与PD-1 联合用于耐药NSCLC 的研究探索，正逐步打开实体瘤应用前景。 管线布局多点开花，创新产品储备丰富 Birelentinib（DZD8586）作为全球首个完 ...

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].