TOKYO, Mar 24 (Pulse News Wire) – Stella Pharma Corporation (4888.T) announced today that it submitted a partial manufacturing and marketing approval application to the Ministry of Health, Labour and Welfare for its boron neutron capture therapy (BNCT) drug, "Borofaran (10B)," targeting inoperable skin angiosarcoma. The application follows positive results from a domestic Phase II clinical trial conducted jointly with CICS Co., Ltd., which showed an efficacy rate of 50.0% (95% confidence interval: 22.2% to 77.8%).
The main evaluation criterion was the effectiveness within 90 days post-BNCT treatment based on central image assessment. Additionally, the median progression-free survival time was recorded at 6.3 months (95% confidence interval: 0.6 to indeterminate). No severe adverse effects were reported during the study, suggesting the potential of BNCT as a promising new treatment option for patients suffering from inoperable skin angiosarcoma. Angiosarcoma is a rare malignant tumor classified under soft tissue tumors affecting blood vessels, predominantly occurring in elderly individuals' scalp skin.
Current treatments such as chemotherapy and radiation are often ineffective, making BNCT a sought-after alternative. In December 2023, the drug received orphan drug designation from the Ministry of Health, Labour and Welfare, providing incentives such as research funding support and priority review processes. This accelerates the regulatory approval timeline compared to general pharmaceutical products. Stella Pharma remains committed to advancing BNCT as a viable therapeutic choice for cancer patients.
The impact on the company's fiscal year 2026 March term performance is expected to be minor.
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