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Business Overview
Stella Pharma aims to commercialize BNCT (boron neutron capture therapy) as a new treatment option for cancer. This technology uses a nuclear fission reaction between the boron stable isotope B-10 and thermal neutrons to selectively destroy cancer cells through radiation therapy. Because BNCT selectively destroys cancer cells, it is expected to minimize damage to normal tissue and improve patients' quality of life (QOL) after treatment.
Stella Pharma obtained manufacturing and marketing approval for Steboronine® in 2020. This product is used to treat unresectable locally advanced or locally recurrent head and neck cancer. Currently, BNCT treatment is being conducted at Sohgo Southeastern Tohoku Hospital and Osaka Medical and Pharmaceutical University Hospital, with revenue generation achieved through a direct sales model via pharmaceutical wholesalers.
Steboronine® (SPM-011), Stella Pharma's development product, has been designated as a subject of the Ministry of Health, Labour and Welfare's Breakthrough Therapy Designation program. The product is manufactured using borofalan (10B) containing high-purity B-10 as the active pharmaceutical ingredient and has the characteristic of selectively accumulating in cancer cells. This enables effective therapeutic responses against cancer cells.
Stella Pharma is building a development pipeline to expand the applicable diseases for BNCT boron pharmaceuticals. The company is conducting clinical trials targeting recurrent malignant glioma, recurrent high-grade meningioma, melanoma, angiosarcoma, newly diagnosed glioblastoma, and thoracic malignancies. Through these efforts, Stella Pharma aims to expand the indications for Steboronine® and provide treatment to more patients.
Stella Pharma is advancing joint research and clinical trials with accelerator manufacturers to promote BNCT adoption and awareness both domestically and internationally. The company is also pursuing regulatory approvals in the United States, Europe, and Asia with an eye toward entering overseas markets. The company positions expansion into the oncology field, where significant growth is anticipated, as a key growth strategy.
Management Policy
Stella Pharma is advancing the practical implementation of BNCT (boron neutron capture therapy) as a new treatment option for cancer. This technology is a form of radiation therapy that selectively destroys cancer cells while minimizing damage to healthy tissue. Stella Pharma obtained manufacturing and marketing approval for Steboronine® in 2020 and it is currently used as a treatment for head and neck cancer.
The company aims to increase awareness of BNCT and secure stable revenue, with sales growth as a key management metric. In the medium to long term, the strategy is to expand approved indications within Japan and pursue global expansion centered on the United States, Europe, and Asia, positioning Steboronine® as a new cancer treatment option.
Stella Pharma is pursuing expanded indications to address medical needs for diseases where effective treatments have not yet been established. In international expansion, the company aims to deepen partnerships with global pharmaceutical companies to achieve early market entry. This approach is intended to accelerate BNCT adoption.
Under its "Medium-Term Management Plan 2027," the company is committed to remaining the front-runner in BNCT pharmaceuticals. Key priorities include expanding approved indications, international expansion, strengthening the new product pipeline, enhancing financial position, acquiring and developing talented personnel, and maintaining stable supply. Through these initiatives, the company aims to achieve sustainable growth.