Approval and Licensing Risk for Gene Medicine Projects
First written in FY2016. 22 of 23 entries say "Restated". Latest entry: FY2025-H1.
The whole theme swung hardest in 2022: 3 of 16 companies on the "Worse" side.
17 other companies' latest entry also says "Restated".
- FY2025-H1RestatedAnnual report
「During the current interim consolidated accounting period, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2024RestatedAnnual report
「また、当社が開発・販売中の体外診断用医薬品や開発中の遺伝子治療薬は、医薬品医療機器等法をはじめとする関連の法規の規制を受けており、商業活動のためには所轄官公庁の承認または許可が必要になります。」
体外診断用医薬品・遺伝子治療薬に関する承認・許認可リスクを継続して記載している。 - FY2024-Q3RestatedAnnual report
「During the first nine months of the fiscal year, there were no new business risks and no material changes to the business risks described in the previous fiscal year's securities report.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2023-Q3RestatedAnnual report
「During the first nine months of the fiscal year, there were no new business risks and no material changes to the business risks described in the previous fiscal year's securities report.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2023-Q2RestatedAnnual report
「During the six-month period ended the second quarter of the current consolidated fiscal year, there were no new business risks or material changes to the business risks described in the previous fiscal year's Annual Securities Report.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2023-Q1RestatedAnnual report
「During the first quarter of the current consolidated fiscal year, there were no newly arising business or other risks, and no material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2022-Q3RestatedAnnual report
「During the first nine months of the fiscal year, there were no new business risks and no material changes to the business risks described in the previous fiscal year's securities report.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2022-Q2RestatedAnnual report
「During the six-month period ended the second quarter of the current consolidated fiscal year, there were no new business risks or material changes to the business risks described in the previous fiscal year's Annual Securities Report.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2022-Q1RestatedAnnual report
「During the first quarter of the current consolidated fiscal year, there were no newly arising business or other risks, and no material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2021-Q2RestatedAnnual report
「During the six-month period ended the second quarter of the current consolidated fiscal year, there were no new business risks or material changes to the business risks described in the previous fiscal year's Annual Securities Report.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2021-Q1RestatedAnnual report
「During the first quarter of the current consolidated fiscal year, there were no newly arising business or other risks, and no material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、新規発生または重要な変更はないとしている。 - FY2020-Q3RestatedAnnual report
「No new business or other risks arose during the nine months ended 31 December. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2020-Q2RestatedAnnual report
「No new business or other risks arose during the six months ended 30 September. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2019-Q3RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the third quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2019-Q2RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the second quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2019-Q1RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the first quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2018-Q3RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the third quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2018-Q2RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the second quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2018-Q1RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the first quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2017-Q3RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the third quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2017-Q2RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the second quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2017-Q1RestatedAnnual report
「There were no newly arising business or other risks during the cumulative consolidated period for the first quarter. Nor were there any material changes to the business or other risks described in the securities report for the previous fiscal year.」
遺伝子医療プロジェクトの許認可リスクについて、重要な変更はないとしている。 - FY2016First statedAnnual report
「当社グループが遺伝子医療事業で研究開発を進めている個々のプロジェクトについて、かかる許認可が得られなかった場合には、当社グループの事業戦略に影響を及ぼす可能性があります。」
医薬品医療機器等法、再生医療等安全性確保法、カルタヘナ法等の規制を挙げている。