Sumitomo Heavy Industries, Ltd.
Official住友重機械工業 株式会社· Corporate Number: 9010701005032
About this English name
Registered English name from gBizINFO (Japanese Government corporate registry).
Enforcement records (3)
- Oct 5, 2017先駆け審査指定制度対象品目の募集薬事法Ministry of Health, Labour and Welfare
Boron Neutron Capture Therapy (BNCT) system for recurrent malignant glioma, inoperable local recurrent head and neck cancer, and locally advanced head and neck cancer (non-squamous cell carcinoma)
- Oct 5, 2017先駆け審査指定制度対象品目の募集Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and Welfare
The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, with the aim of facilitating their early practical use in Japan.
- Feb 28, 2017指定薬事法Ministry of Health, Labour and Welfare
This is a device used for neutron beam irradiation in boron neutron capture therapy (BNCT). The applicable diseases are malignant glioma and head and neck cancer. A Phase I clinical trial conducted domestically with 12 cases reported a one-year survival rate of 66.7%. A clinical study targeting head and neck cancer conducted at the same university with 62 cases reported an response rate of 58%, suggesting high efficacy.
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Language
日本語版を見る (Japanese)Registry data
- Corporate Number (法人番号)
- 9010701005032
- Registered address
- 東京都品川区大崎２丁目１番１号
- Status
- Active
For compliance use
This profile aggregates public Japanese government records. Always cross-reference the Corporate Number when matching this entity in your systems — Japanese English company names are often inconsistent across sources.