指定 against Sumitomo Heavy Industries, Ltd.
Action summary
- Company
- Sumitomo Heavy Industries, Ltd.OfficialOriginal: 住友重機械工業株式会社Corporate Number: 9010701005032
- Governing law
- 薬事法薬事法
- Action type
- 指定指定
- Action date
- February 28, 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
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.
Show original Japanese text
ホウ素中性子捕捉療法（BNCT）に用いる中性子線を照射するための装置である。適応疾患は、悪性神経膠腫と頭頸部癌である。国内で実施中の第I相治験（12例）で確認した1年生存率は66.7％、同大学で実施した頭頸部癌を対象とした臨床研究（62例）で確認した奏効率は58％であるとの報告があり、高い有効性が示唆されている。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
Watch this company
Get an email when Sumitomo Heavy Industries, Ltd. has new enforcement actions or registry changes (representative, address, business status). Sign-in is via a one-time email link — no password.
Language
日本語版を見る (Japanese)Company info
- English name
- Sumitomo Heavy Industries, Ltd. Official
- Japanese name
- 住友重機械工業 株式会社
- Corporate Number
- 9010701005032
- Registered address
- 東京都品川区大崎２丁目１番１号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.