Management Objectives Focused on Development Program Progress and Pipeline Expansion
First written in FY2018. 11 of 27 entries say "Restated". Latest entry: 2026-09-17.
5 other companies' latest entry also says "Restated".
- FY2026ReframedAnnual report
「Based on the track record of アクーゴ®, which received conditional and time-limited approval in Japan, the Group aims to become a global leader in regenerative medicine through 3 pillars: realizing its U.S. business, succeeding in cerebral infarction, and establishing Japan as the central base.」
Based on アクーゴ®'s domestic approval track record, the management objectives were organized around 3 pillars: the U.S. business, cerebral infarction and establishing Japan as the central base. - FY2026-H1RestatedAnnual report
「The Company will pursue its initiatives with greater awareness of the "back to our roots" concept, which it has identified since the previous fiscal year as an important pillar of its medium- to long-term growth strategy. Specifically, it will target 2 diseases, chronic-stage cerebral infarction and chronic-stage traumatic brain injury, in the U.S. market, where the patient population is large.」
In parallel with preparations for the launch of アクーゴ® in Japan, the Company reaffirmed its "back to our roots" growth strategy of bringing regenerative medicine from Japan to the world and its focus on cerebral infarction and traumatic brain injury in the United States. - FY2025ReframedAnnual report
「Based on the track record of アクーゴ®, which received conditional and time-limited approval in Japan, the Group aims to become a global leader in regenerative medicine through 3 pillars: restarting its U.S. business, taking on cerebral infarction again, and establishing Japan as its central base.」
The management objectives were reorganized and restructured from a phase centered on the domestic approval application and approval process into 3 pillars based on アクーゴ®'s track record: restarting the U.S. business, taking on cerebral infarction again, and establishing Japan as the central base. - FY2025-H1ReframedAnnual report
「Going forward, the Company will return to its founding vision, unchanged since its establishment, of "bringing regenerative medicine from Japan to the world" and resume advancing its global business. With the United States, its largest market, at the center, it plans to consult with regulatory authorities in Japan and the United States on conducting new clinical trials for chronic-stage cerebral infarction and other indications, drawing on アクーゴ®'s track record in Japan.」
The Company's management focus shifted from prioritizing the domestic approval application and approval process to advancing a global business centered on the United States and new clinical trials based on アクーゴ®'s track record in Japan. - FY2024AdvancedAnnual report
「The Company is currently giving top priority to the development program for SB623, its proprietary regenerative cell therapy, for chronic-stage traumatic brain injury in Japan.」
Under the management objective of prioritizing development program progress, the domestic chronic-stage traumatic brain injury program was advanced as the highest priority and, following the Pharmaceutical Affairs Council's deliberations, moved to the stage of submitting additional quality-related data. - FY2024-Q3SoftenedAnnual report
「We are currently responding to the PMDA’s review to obtain approval and steadily preparing our sales infrastructure so that we can promptly begin sales after approval. The timing of approval is not something we can determine, but we aim to obtain approval in March 2024.」
Under its policy of prioritizing development program progress, the approval target was changed from "during the current fiscal year" as stated previously to March 2024. The Company continues to respond to the review and prepare its sales structure. - FY2023AdvancedAnnual report
「To obtain approval, we are addressing regulatory review matters and issues relating to yield, which has decreased compared with the time of application, and aim to obtain approval during the current fiscal year.」
Under its management objective of prioritizing development program progress, the Company proceeded with the review process and addressed manufacturing yield issues after completing the approval application, setting approval during the current fiscal year as its target. - FY2023-Q3RestatedAnnual report
「To obtain approval, we will respond to the PMDA’s review while steadily preparing our sales infrastructure so that we can promptly begin sales after approval.」
The Company reaffirmed that, under its management focus on development program progress and establishment of a manufacturing and marketing structure, it is in the stage of responding to the PMDA review and preparing for sales following completion of the approval application. - FY2023-Q2RestatedAnnual report
「To obtain approval, we will respond to the PMDA’s review while steadily preparing our sales infrastructure so that we can promptly begin sales after approval.」
The Company reaffirmed that, under its management focus on development program progress and establishment of a manufacturing and marketing structure, it is in the stage of responding to the PMDA review and preparing for sales following completion of the approval application. - FY2023-Q1RestatedAnnual report
「Following the designation, the Company held consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) under the Sakigake Designation System, completed the Sakigake comprehensive evaluation consultation in January 2022, and in March 2022 completed its first domestic application for marketing approval of a regenerative medical product (the "approval application").」
The Company reaffirmed that, with respect to its management objective of prioritizing development program progress and the pipeline, it is in the stage of responding to the PMDA review following completion of the domestic approval application. - FY2022AdvancedAnnual report
「For the domestic SB623 chronic-stage traumatic brain injury program, the Company completed the Sakigake comprehensive evaluation consultation by January 2022 and, in March 2022, completed its first application in Japan for marketing approval of a regenerative medical product.」
The completion of the domestic approval application for the SB623 chronic-stage traumatic brain injury program was added as a specific milestone under the management objective of prioritizing development program progress. - FY2022-Q3AdvancedAnnual report
「The SB623 chronic-phase traumatic brain injury program is currently in the phase of the Sakigake Comprehensive Evaluation Consultation. This consultation is divided into five parts: clinical, nonclinical, quality, reliability and GCTP, and authorization to file is obtained for each part.」
A specific development milestone was reported under the management objective of prioritizing development program progress: the SB623 chronic-stage traumatic brain injury program had advanced to the Sakigake comprehensive evaluation consultation stage. - FY2022-Q2RestatedAnnual report
「Going forward, in order to maximize the value of SB623 through the selective allocation and concentration of management resources, the company will prioritize preparations for domestic development of the ischemic stroke and intracerebral hemorrhage programs in parallel with preparations for filing a domestic marketing authorization application for SB623 for chronic traumatic brain injury as soon as possible.」
The Company reaffirmed its management focus on the domestic approval application for SB623 and domestic development of the cerebral infarction and cerebral hemorrhage programs to maximize the value of SB623. - FY2021-Q3RestatedAnnual report
「To maximize the value of SB623 through the selective allocation and concentration of management resources, the Company will prioritize domestic development of its cerebral infarction and cerebral hemorrhage programs in parallel with preparations for the earliest possible domestic approval application for SB623 for chronic-stage traumatic brain injury.」
To maximize the value of SB623, the Company reaffirmed its policy of selectively allocating and concentrating management resources, prioritizing preparations for the domestic approval application and domestic development of the cerebral infarction and cerebral hemorrhage programs in parallel. - FY2021-Q2ReframedAnnual report
「To maximize the value of SB623 through the selective allocation and concentration of management resources, the Company will prioritize domestic development of its cerebral infarction and cerebral hemorrhage programs in parallel with preparations to file a domestic approval application for SB623 for chronic-stage traumatic brain injury during the current fiscal year. The global Phase III SB623 traumatic brain injury study, which had been scheduled to begin during the current fiscal year, has been postponed until the following fiscal year or later.」
The management policy focused on development program progress was reoriented toward prioritizing the domestic approval application and domestic development of the cerebral infarction and cerebral hemorrhage programs, while postponing the global Phase III traumatic brain injury study. - 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 Company reaffirmed its management focus on advancing the SB623 development program and pursuing commercialization during the research and development stage. - FY2020RestatedAnnual report
「While the Group remains in the research and development stage, it is not setting management indicators such as ROA and ROE as targets, but is conducting its business activities with a focus on progress in development programs and pipeline expansion.」
The Company reaffirmed management objectives focused on development program progress, pipeline expansion and establishment of a manufacturing and marketing structure, rather than ROA and ROE. - FY2020-Q1AdvancedAnnual report
「The Phase II clinical trials in Japan and the United States for the Group's SB623 chronic-stage traumatic brain injury program, which it is advancing independently, involved 61 subjects and produced favorable results in November 2018: "The SB623 treatment group demonstrated a statistically significant improvement in motor function compared with the control group and achieved the primary endpoint." In April 2019, the domestic chronic-stage traumatic brain injury program was designated by the Ministry of Health, Labour and Welfare as an eligible product under the Sakigake Designation System for regenerative medical products.」
Following achievement of the primary endpoint in the development program, the domestic program made specific progress in the approval process through its Sakigake designation. - FY2019Failure to achieve the primary endpoint in the chronic-stage cerebral infarction studyAnnual report
「In January 2019, the Phase 2b clinical trial of the SB623 chronic-stage cerebral infarction program, conducted in the United States jointly with Dainippon Sumitomo Pharma Co., Ltd. in 163 subjects, produced analysis results showing that its primary endpoint had not been met.」
As the Company places priority on development program progress as a management objective, the Phase IIb chronic-stage cerebral infarction study failed to achieve its primary endpoint, and the Company has moved to a detailed analysis and reconsideration of its future plans. - FY2019-Q3AdvancedAnnual report
「The SB623 treatment group achieved the primary endpoint, demonstrating a statistically significant improvement in motor function compared with the control group.」
The chronic-stage traumatic brain injury study, a key development program, achieved its primary endpoint, adding a specific milestone to the management objective of advancing development programs. - FY2019-Q2RestatedAnnual report
「Through this financing, the Group aims to strengthen its capital and use the funds raised for growth investments, thereby steadily addressing the business-critical issues underlying its medium- to long-term growth, including research and development for geographic expansion and expansion of indications, and the establishment of manufacturing, logistics and sales structures for commercialization, with the aim of enhancing corporate value.」
The Group reaffirmed its approach of using the funds raised for growth investments and pursuing geographic expansion, expansion of indications and establishment of a commercialization structure as management objectives during the research and development stage, with the aim of enhancing corporate value. - FY2018First statedAnnual report
「We believe that the most important management priority is to reliably and swiftly advance the entire process, from research and development through clinical development and the establishment of a manufacturing and marketing structure with the post-marketing stage in mind. Accordingly, while the Group remains in the research and development stage, it is not setting management indicators such as ROA and ROE as targets, but is conducting its business activities with a focus on progress in development programs and pipeline expansion.」
The Company indicated that, rather than ROA and ROE, progress in development programs and pipeline expansion are its principal management objectives during the research and development stage.