FUDANZHANGJIANG (01349) Issues Profit Warning, Forecasts 2025 Net Loss Attributable to Owners of Approximately RMB 120 Million to 180 Million

Stock News
01/30

FUDANZHANGJIANG (01349) has announced that the Group anticipates recording an unaudited net loss attributable to owners of the parent of approximately RMB 120 million to 180 million for the year ending December 31, 2025 (2024: audited net profit attributable to owners of the parent of RMB 39.7339 million). The unaudited net loss attributable to owners of the parent after deducting non-recurring gains and losses is expected to be approximately RMB 140 million to 200 million (2024: audited net profit of RMB 5.1452 million after deducting non-recurring gains and losses).

The primary reasons for the performance change in this period are: 1) The Group is actively advancing its R&D projects, leading to a continuous increase in the proportion of R&D investment relative to operating revenue. During the reporting period, patient enrollment for the Phase III clinical trial of FDA018 Antibody-Drug Conjugate (the anti-Trop2 antibody conjugated with SN38 project) for treating triple-negative breast cancer was completed ahead of schedule, with cumulative enrollment exceeding 350 cases; data collection and statistics for this project are currently underway, and the Group plans to submit a New Drug Application as soon as possible. Enrollment for the Phase II clinical study of the FDA022 Antibody-Drug Conjugate (the anti-HER2 antibody conjugated with BB05 project) for HER2-low breast cancer has concluded, and an End-of-Phase II meeting with regulators was held during the reporting period. The Group's wholly-owned subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., continuously supported the industrialization of the Group's ADC R&D projects during the period, undertaking activities such as commercial-scale technology transfer, process validation, and production of later-stage trial samples. Furthermore, the Group's photodynamic drug R&D projects progressed steadily according to plan, including the acceptance of the Marketing Authorization Application for Aminolevulinic Acid Hydrochloride Powder for Oral Solution for the intraoperative visualization of high-grade glioma. The Group's R&D investment during the reporting period was approximately RMB 350 million. 2) In 2024, Doxorubicin Hydrochloride Liposome Injection was included in the National Centralized Drug Procurement list for the first time, but the company's product, Libao® (里葆多®), was not selected. Based on the procurement rules and changes in the competitive landscape, the company prudently adjusted the product's sales strategy during the reporting period, including, but not limited to, implementing a gradual reduction in its market retail price effective May 1, 2025. Consequently, the profit margin for Libao® has decreased correspondingly. Compared with the same period last year, this product's contribution to the Group's profit decreased by approximately RMB 100 million.

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