迪哲（江苏）医药股份有限公司 2025年第一季度报告

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]