Summary of Key Points Core Viewpoint - Fudan Zhangjiang (01349) expects a net loss attributable to shareholders of approximately RMB 120 million to RMB 180 million for the year ending December 31, 2025, compared to a net profit of RMB 39.73 million for 2024 [1] Group Performance and R&D Progress - The company is actively advancing its R&D projects, with R&D expenditure as a percentage of revenue continuously increasing. During the reporting period, the Phase III clinical trial for the FDA018 antibody-drug conjugate (anti-Trop2 antibody conjugate SN38 project) was completed ahead of schedule, with over 350 cases enrolled [2] - The company plans to submit a listing application as soon as the data results are collected. The Phase II clinical study for the FDA022 antibody-drug conjugate (anti-HER2 antibody conjugate BB05 project) has completed enrollment, and a clinical discipline communication meeting (EOP2 meeting) with regulators was held during the reporting period [2] - The wholly-owned subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., has been supporting the industrialization of the company's antibody-drug conjugate (ADC) R&D projects, including commercial-scale production technology transfer and production process validation [2] - The development of photodynamic drug projects is progressing as planned, with the application for drug registration for the oral solution of ammonium pentobarbital for intraoperative visualization in high-grade glioma having been accepted [2] - R&D investment during the reporting period was approximately RMB 350 million [2] Sales Strategy Adjustments - In 2024, the doxorubicin liposome injection was included in the national centralized procurement directory, but the company's product, Liposome Doxorubicin, was not selected. Consequently, the company adjusted its sales strategy for this product, including a gradual reduction in market retail prices starting May 1, 2025 [3] - This adjustment led to a corresponding decrease in the profit margin of Liposome Doxorubicin, with a year-on-year reduction in profit contribution of approximately RMB 100 million compared to the same period last year [3]
复旦张江发盈警 预计2025年度归母净亏损约1.2亿至1.8亿元