Strategy to expand the domestic indications for Steboronin

「In March 2026, we filed partial-change applications for marketing authorization for recurrent meningioma and angiosarcoma with the Ministry of Health, Labour and Welfare.」

「We achieved the primary endpoint of this trial. No serious adverse reactions or other safety issues were observed, and there were no new concerns. We will share the trial results with the relevant authorities and continue discussions toward filing applications for approval in the fiscal year ending March 2026 for recurrent high-grade meningioma and angiosarcoma.」

「For recurrent high-grade meningioma and angiosarcoma, excluding head and neck cancer, we will work toward filing applications for approval in fiscal 2025, the target year set out in the Medium-Term Management Plan 2027.」

「In September 2024, the Ministry of Health, Labour and Welfare designated recurrent malignant glioma and recurrent meningioma as orphan diseases. We will continue to seek early approval for these indications.」

「In our drug discovery pipeline, in December 2023 we obtained orphan drug designation for unresectable cutaneous angiosarcoma. This designation provides benefits including priority review in the marketing authorization review process and government research funding.」

「In our domestic business, with a view to expanding the scope of our BNCT business in the future, we entered into an agreement concerning the investigator-initiated Phase I clinical trial for newly diagnosed glioblastoma planned by the University of Tsukuba, and」

「In November 2022, we initiated a domestic Phase II clinical trial for angiosarcoma, and in January 2023, radiation was administered to the first subject. We are also consulting with the Ministry of Health, Labour and Welfare regarding designation as an orphan drug for angiosarcoma.」

「In November 2022, we initiated a domestic Phase II clinical trial for angiosarcoma.」

「Against this backdrop, we steadily advanced efforts to expand the indications for BNCT after completing the 90-day observation period for the primary endpoint of the Phase I clinical trial for malignant melanoma and angiosarcoma, one of our development pipeline programs.」

「Our medium- to long-term management strategy is to expand the indications for Steboronin® in Japan to establish it as the foundation of our business, develop our business globally, particularly in the United States, Europe and Asia, and provide Steboronin® in countries around the world as a new cancer treatment option.」

「In Japan, we submitted a clinical trial notification in September 2019 and are proceeding with preparations for a Phase II clinical trial while conducting a Phase I clinical trial.」

「Our medium- to long-term management strategy is to expand the indications for Steboronin® in Japan to establish it as the foundation of our business, develop our business globally, particularly in the United States and Europe, and provide Steboronin® in countries around the world as a new cancer treatment option.」