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Sumitomo Heavy Industries, Ltd.

住友重機械工業 株式会社· Corporate Number: 9010701005032

住友重機械工業株式会社は東京都品川区大崎に本店を置き、法人として現存している企業である。薬事法に関して2017年10月に2件の処分歴がある。

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Public Record Summary

Actions in last 3 years
0records
Actions in last year
0records
Latest action
about 8 years ago

5 Oct 2017

Total penalties
-

Enforcement and administrative action history

薬事法先駆け審査指定制度対象品目の募集
Confirmed entity match

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)

5 Oct 2017Ministry of Health, Labour and Welfare
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Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices先駆け審査指定制度対象品目の募集
RepeatConfirmed entity match

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.

5 Oct 2017Ministry of Health, Labour and Welfare
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薬事法指定
Confirmed entity match

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.

28 Feb 2017Ministry of Health, Labour and Welfare
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Language

日本語版を見る (Japanese)

Registry data

English name
Sumitomo Heavy Industries, Ltd.
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
Status
Active

Note: This company may not have detailed gBizINFO data, or RegBase has not completed enrichment yet. The public sources below may contain supplemental registry information.

View on gBizINFO ↗View on National Tax Agency Corporate Number site ↗

gBizINFO: fetched 25 Apr 2026

Data sources

Breakdown by law

Breakdown by action type

  • 先駆け審査指定制度対象品目の募集
    2
  • 指定
    1

About this English name

Registered English name from gBizINFO (Japanese Government corporate registry).

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