Commercialization of the proprietary regenerative cell therapy SB623
First written in FY2017-Q1. 23 of 38 entries say "Restated". Latest entry: 2026-10-05.
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- 2026-10-05AdvancedOther Disclosures
「今回の投与は、北海道大学病院において、所定の手続きを経て実施されました。」
アクーゴ®は販売開始後、実際の医療現場で市販後1例目の投与に至り、事業化が販売段階から治療実施段階へ進んだ。 - FY2027-H1AdvancedAnnual report
「Subsequently, Acugo® was listed on the National Health Insurance drug price list in May 2026, its drug price was set at ¥72 million, and sales began.」
For Acugo®, inclusion in the National Health Insurance drug price list and the determination of its ¥72 million drug price in May 2026 led to the start of sales. SB623's commercialisation progressed from the approval and shipment-preparation stage to the sales execution stage. - FY2026AdvancedAnnual report
「In July 2024, the previous fiscal year, Acugo® obtained conditional, time-limited marketing approval in Japan. In December 2025, the current fiscal year, a partial change to the marketing approval was approved, lifting the shipping restrictions. Preparations for sales are under way, and the initial shipment is expected in the second half of the following fiscal year (August 2026–January 2027).」
For Acugo®, approval of the partial change to the marketing approval was obtained in December 2025, lifting the shipping restrictions. The Company proceeded with sales preparations and expects the initial shipment in August 2026–January 2027. - FY2026-H1AdvancedAnnual report
「Two manufacturing runs have now met all acceptance criteria in specification testing and characterisation and have been judged compliant. In June 2025, the Company completed a partial change application for Acugo®'s marketing approval. Following review by the authorities and the relevant committee, approval is expected in the second half of the fiscal year ending January 2026 (August 2025–January 2026). Acugo® is then scheduled to be launched after its inclusion in the National Health Insurance drug price list.」
For Acugo®, 2 commercial-product manufacturing runs were completed successfully, and the partial change application for the marketing approval was also completed. The next steps were defined as obtaining approval in the second half of the fiscal year ending January 2026 and launching the product after its inclusion in the National Health Insurance drug price list. - FY2025AdvancedAnnual report
「To confirm equivalence and comparability, one of approximately 2 planned batches of commercial product was manufactured and judged compliant after meeting all acceptance criteria in specification testing and characterisation. Manufacturing of the remaining batch to obtain a second compliant result has already begun. If that batch is compliant, the Company will use the results to file a partial change application for the marketing approval and seek approval to lift the shipping restrictions. Accordingly, Acugo® is expected to become available for shipment in the second quarter (May–July 2025).」
For Acugo®, 1 of approximately 2 commercial-product manufacturing runs was judged compliant based on specification testing and characterisation, and the second run was started. The next steps and timing were defined, including the partial change application after compliance and the expected availability for shipment in May–July 2025. - FY2025-H1AdvancedAnnual report
「On 31 July of the following month, the Ministry of Health, Labour and Welfare granted Acugo® conditional, time-limited marketing approval in Japan for the indication of improving motor paralysis in the chronic phase following traumatic brain injury.」
SB623 obtained conditional, time-limited marketing approval in Japan, reaching a significant regulatory milestone toward commercialisation. - FY2024-Q3RestatedAnnual report
「Against this backdrop, the Group advanced research and development with the aim of commercialising its proprietary regenerative cell therapy SB623, primarily targeting central nervous system disorders with high unmet medical needs.」
The basic policy of primarily targeting central nervous system disorders with high unmet medical needs and advancing research and development toward the commercialisation of SB623 has been reaffirmed. - FY2024-Q2RestatedAnnual report
「Against this backdrop, the Group advanced research and development with the aim of commercialising its proprietary regenerative cell therapy SB623, primarily targeting central nervous system disorders with high unmet medical needs.」
The basic policy of targeting central nervous system disorders with high unmet medical needs and advancing research and development toward the commercialisation of SB623 has been reaffirmed. - FY2024-Q1RestatedAnnual report
「Against this backdrop, the Group advanced research and development with the aim of commercialising its proprietary regenerative cell therapy SB623, primarily targeting central nervous system disorders with high unmet medical needs.」
The basic policy of targeting central nervous system disorders with high unmet medical needs and advancing research and development toward the commercialisation of SB623 has been reaffirmed. - FY2023RestatedAnnual report
「Against this backdrop, the Group advanced research and development with the aim of commercialising its proprietary regenerative cell therapy SB623, primarily targeting central nervous system disorders with high unmet medical needs.」
The basic policy of primarily targeting central nervous system disorders with high unmet medical needs and advancing research and development toward the commercialisation of SB623 has been reaffirmed. - FY2023-Q3RestatedAnnual report
「Against this backdrop, the Group advanced research and development with the aim of commercialising its proprietary regenerative cell therapy SB623, primarily targeting central nervous system disorders with high unmet medical needs.」
The basic policy of advancing research and development toward the commercialisation of SB623, primarily targeting central nervous system disorders with high unmet medical needs, has been reaffirmed. - FY2023-Q2RestatedAnnual report
「The Group advanced research and development with the aim of commercialising its proprietary regenerative cell therapy SB623, primarily targeting central nervous system disorders with high unmet medical needs.」
The basic policy of commercialising SB623 as a regenerative cell therapy for central nervous system disorders and continuing research and development has been reaffirmed. - FY2023-Q1RestatedAnnual report
「Against this backdrop, the Group advanced research and development with the aim of commercialising its proprietary regenerative cell therapy SB623, primarily targeting central nervous system disorders with high unmet medical needs.」
The basic policy of primarily targeting central nervous system disorders with high unmet medical needs and advancing research and development toward the commercialisation of SB623 has been reaffirmed. - FY2022-Q2RestatedAnnual report
「Against this backdrop, the Company is pursuing the commercialisation of its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders」
The basic policy of commercialising SB623 as a new treatment for central nervous system disorders has been reaffirmed. - FY2021-Q3RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The basic policy of commercialising SB623 as a treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2021-Q1RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2020RestatedAnnual report
「The Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a new treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2020-Q3RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2020-Q1RestatedAnnual report
「Against this backdrop, the Group, comprising the Company and its consolidated subsidiary SanBio, Inc. (Mountain View, California, United States), is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a new treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2019RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2019-Q3RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a new treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2019-Q2RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a new treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2018RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a core product for central nervous system disorders and advancing development primarily in Japan and the United States has also been reaffirmed in the annual report. - FY2018-Q3RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a new treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2018-Q2RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a new treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2018-Q1RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a new treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2017RestatedAnnual report
「Against this backdrop, the Group, comprising the Company and its consolidated subsidiary SanBio, Inc. (Mountain View, California, United States), is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a core product for central nervous system disorders and advancing development primarily in Japan and the United States has also been reaffirmed in the annual report. - FY2017-Q3RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States with the aim of commercialising its proprietary regenerative cell therapy SB623 as a new treatment for central nervous system disorders.」
The policy of commercialising SB623 as a new treatment for central nervous system disorders and advancing development primarily in Japan and the United States has been reaffirmed. - FY2017-Q2RestatedAnnual report
「Against this backdrop, the Group is advancing development primarily in Japan and the United States toward the commercialisation of its proprietary regenerative cell therapy SB623.」
The policy of advancing development primarily in Japan and the United States toward the commercialisation of the regenerative cell therapy centred on SB623 is reiterated. - FY2017-Q1First statedAnnual report
「The Group is advancing development primarily in Japan and the United States toward the commercialisation of its proprietary regenerative cell therapy SB623.」
The commercialisation policy for the regenerative cell business centred on SB623 is set out.