Early launch of SB623 using Japan’s accelerated approval system
First written in FY2017. 19 of 38 entries say "Advanced", first in FY2019-Q3. Latest entry: FY2027-H1.
No other company in this theme has enough history to compare yet.
- FY2027-H1AchievedAnnual 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.」
The key objective of launching SB623 in Japan using the expedited approval system has been achieved through inclusion in the National Health Insurance drug price list and the launch of sales. - FY2026AdvancedAnnual report
「In December 2025, following approval of partial changes to the marketing authorization particulars, we began preparing for the launch. We plan to achieve the initial shipment in the second half of the following consolidated fiscal year. We also plan to conduct post-marketing clinical trials and other studies within the 7-year marketing authorization period, which is an approval condition, and obtain full approval.」
Following approval of partial changes to the approved particulars after conditional and time-limited approval, the process has been outlined as initial shipment in the second half of the following consolidated fiscal year and obtaining full approval within the 7-year approval period. - FY2026-H1AdvancedAnnual report
「After 2 manufacturing runs, all standards were met in specification testing and characterization analyses, and the product was determined to be compliant. Following this, we completed the application for approval of partial changes to the marketing authorization particulars for Akugo® in June 2025. Following the authorities’ review and committee deliberations, we expect to obtain approval in the second half of the fiscal year ending January 2026 (August 2025 to January 2026). We plan to launch Akugo® after its inclusion in the National Health Insurance drug price list. We also plan to promote the adoption of Akugo® in Japan and, during that process, conduct post-marketing clinical trials and other studies within the 7-year marketing authorization period, which is the second approval condition, and obtain full approval.」
The early approval strategy has progressed to the stage of 2 compliant commercial product manufacturing runs, completion of the application for approval of partial changes to the approved particulars, anticipated approval in the second half of the fiscal year ending January 2026, launch following inclusion in the National Health Insurance drug price list, and obtaining full approval within the 7-year period. - FY2025AdvancedAnnual report
「Manufacturing for the remaining 1 conformity assessment has already begun. If the product passes this assessment, we will use the results to submit an application for partial changes to the approved marketing authorization particulars and aim to obtain approval to lift the shipment restrictions. Accordingly, we expect Akugo® to become ready for shipment in the second quarter (May to July 2025). Thereafter, we plan to promote the adoption of Akugo® in Japan and, during that process, conduct post-marketing clinical trials and other studies within the 7-year marketing authorization period, which is the second approval condition, and obtain full approval.」
The early commercialization strategy following conditional and time-limited approval has been specified as a process consisting of the remaining manufacturing conformity assessment, approval of partial changes to the approved particulars, readiness for shipment in May to July 2025, and obtaining full approval within the 7-year approval period. - FY2025-H1AdvancedAnnual report
「Going forward, we will return to our founding vision, unchanged since the company was established, of “bringing regenerative medicine from Japan to the world,” and resume advancing our global business. With the United States, the largest market, as our primary focus, and based on our track record with Akugo® in Japan, we plan to consult with regulatory authorities in Japan and the United States toward conducting new clinical trials for chronic cerebral infarction and other conditions. For the chronic traumatic brain injury program, which has received conditional and time-limited approval in Japan, we will work toward launching Akugo®. First, while promptly carrying out approximately 2 batches of commercial product manufacturing, we will confirm comparability/equivalence, one of the approval conditions, and work toward being in a position to ship the product during the first quarter of the fiscal year ending January 2026 (February to April 2025). Thereafter, we plan to promote the adoption of Akugo® in Japan and, during that process, conduct post-marketing clinical trials and other studies within the 7-year marketing authorization period, which is the second approval condition, and obtain full approval.」
The next-stage plan has been specified: obtaining conditional and time-limited approval using Japan’s expedited approval system, carrying out approximately 2 batches of commercial product manufacturing, becoming ready for shipment during the first quarter of the fiscal year ending January 2026, and obtaining full approval following post-marketing clinical trials and other studies within the 7-year approval period. - FY2025-Q1AdvancedAnnual report
「This application had been designated for continued deliberation at the meeting of the Regenerative Medical Products and Biotechnology Committee of the Pharmaceutical Affairs and Food Sanitation Council held on 25 March 2024. Accordingly, on 12 June, the Ministry of Health, Labour and Welfare announced that the committee would meet on 19 June. The agenda includes deliberation of “whether to grant marketing authorization for the regenerative medical product Akuugo Intracerebral Implantation Injection, developed by the company as SB623, and whether conditions and a time limit are required, as well as whether a re-examination period should be designated.” The committee will therefore deliberate whether to approve the company’s SB623 product.」
The domestic early approval strategy has progressed to the stage at which the Pharmaceutical Affairs Council will deliberate on whether to grant approval, the conditions and time limit, and whether a re-examination period is required following continued deliberations. - FY2024AdvancedAnnual report
「For the domestic SB623 chronic traumatic brain injury program, based on the results of deliberations at the Regenerative Medical Products and Biologically Derived Technologies Subcommittee of the Pharmaceutical Affairs and Food Sanitation Council held on 25 March 2024, we will consult with the authorities and submit additional quality-related data and other materials toward obtaining marketing authorization as soon as possible.」
Following deliberations by the Pharmaceutical Affairs Council, the early approval strategy has progressed to the stage of submitting additional quality-related data and consulting with the authorities toward obtaining approval. - 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 the domestic early approval strategy, the target timing for obtaining approval was changed from “during the current fiscal year” as of the previous update to March 2024. Responses to PMDA’s review and preparations for launching sales following approval are continuing. - FY2024-Q2RestatedAnnual report
「We are currently responding to the PMDA’s review and addressing the yield-related issue, namely, that yield has declined compared with the time of filing, in order to obtain approval. We are also 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 during the current fiscal year.」
The early approval strategy of pursuing approval of SB623 in Japan and the prompt launch of sales following approval while responding to PMDA’s review and addressing the yield issue has been reaffirmed. - FY2024-Q1RestatedAnnual report
「We are currently responding to the PMDA’s review and addressing the yield-related issue, namely, that yield has declined compared with the time of filing, in order to obtain approval. We are also 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 during the current fiscal year.」
The early approval strategy of pursuing approval during the current fiscal year while responding to PMDA’s review and addressing the yield issue has been reaffirmed. - FY2023AdvancedAnnual report
「For the domestic SB623 chronic traumatic brain injury program, we completed the Sakigake comprehensive evaluation consultation by January 2022 and completed our first application for marketing authorization of a regenerative medical product in March 2022. Although the timing of approval cannot be determined by our company, we are responding to the regulatory authorities’ review and addressing the issue of reduced yield, compared with the yield at the time of application, with the aim of obtaining approval during the current fiscal year.」
Following completion of the Sakigake comprehensive evaluation consultation and the application for approval, the program has progressed to the stage of responding to the review, including addressing the reduced-yield issue, with the aim of obtaining approval during the current fiscal year. - 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 domestic early approval strategy of responding to PMDA’s review and establishing a structure for the prompt launch of sales following approval has been reaffirmed. - 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 domestic early approval strategy of responding to PMDA’s review and establishing a structure for the prompt launch of sales following approval has been reaffirmed. - FY2023-Q1RestatedAnnual 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.」
For the domestic early approval strategy, the policy of responding to PMDA’s review and preparing for the prompt launch of sales following approval has been reaffirmed. - FY2022AdvancedAnnual report
「We completed the Sakigake comprehensive evaluation consultation by January 2022 and completed our first application for marketing authorization of a regenerative medical product in March 2022.」
Specific progress in Japan’s early approval strategy has been reported, including completion of the Sakigake comprehensive evaluation consultation and completion of our first application for approval in March 2022. - 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.」
For the domestic early approval strategy for SB623, the process has moved to the Sakigake comprehensive evaluation consultation phase, and the procedures for proceeding to the application for approval after obtaining permission to submit each of the 5 parts have been specified. - FY2022-Q2RestatedAnnual report
「We will continue discussions with PMDA toward obtaining marketing authorization in Japan for SB623 as soon as possible, while steadily preparing to establish a sales structure following approval.」
The policy of proceeding with discussions with PMDA and pursuing early approval of SB623 in Japan and establishment of a sales structure following approval has been reaffirmed. - FY2021SoftenedAnnual report
「We will continue discussions with PMDA toward obtaining marketing authorization in Japan for SB623 as soon as possible.」
The policy of pursuing expedited approval in Japan and discussions with PMDA are continuing, but the previously specified submission timing during the fiscal year ending January 2021 was not provided, and the wording has changed to “as soon as possible.” - FY2021-Q3SoftenedAnnual report
「In Japan, we are actively consulting with the Pharmaceuticals and Medical Devices Agency (PMDA) under the SAKIGAKE designation system, aiming to submit an application for marketing approval during the fiscal year ending January 2021. However, we currently expect that the application is highly likely to be delayed beyond the fiscal year ending January 2021.」
Although discussions with PMDA regarding an application for approval of SB623 in Japan using the expedited approval system and other measures are progressing, it was indicated that the planned submission during the fiscal year ending January 2021 is highly likely to be delayed. - FY2021-Q1RestatedAnnual report
「We are currently consulting with the Pharmaceuticals and Medical Devices Agency (PMDA) and plan to submit an application for marketing approval as a regenerative medical product during the fiscal year ending January 2021 (February 2020 to January 2021).」
Following consultations with PMDA, the plan to submit an application for approval of SB623 in Japan during the fiscal year ending January 2021 by utilizing the conditional and time-limited approval system and other measures has been reaffirmed. - FY2020AdvancedAnnual report
「We are currently conducting face-to-face consultations and preliminary meetings with the PMDA. We plan to complete the SAKIGAKE comprehensive evaluation consultation and submit an application for marketing approval as a regenerative medical product during the fiscal year ending January 2021 (February 2020 to January 2021).」
In addition to pursuing utilization of the expedited approval system, we have consulted with PMDA and plan to hold a Sakigake comprehensive evaluation consultation and submit an application for approval during the fiscal year ending January 2021. - FY2020-Q3SoftenedAnnual report
「The planned timing of the application for approval was reviewed and changed to the fiscal year ending January 2021 (February 2020 to January 2021) to allow sufficient time to prepare for commercial production and fulfill the responsibility of ensuring a stable post-launch supply.」
The planned timing for submitting an application for approval under Japan’s conditional and time-limited approval system was pushed back to the fiscal year ending January 2021 to prioritize preparations for product manufacturing. - FY2020-Q1AdvancedAnnual report
「In April 2019, the domestic chronic-phase traumatic brain injury program was designated by the Ministry of Health, Labour and Welfare as a product eligible for the SAKIGAKE designation system for regenerative medical products. This designation makes it possible to receive priority consultations and reviews from the Pharmaceuticals and Medical Devices Agency (PMDA) concerning regulatory approval. We aim to use this benefit and Japan's conditional and time-limited approval system for regenerative medical products to submit an application for marketing approval as a regenerative medical product during the fiscal year ending January 2020 (February 2019 to January 2020).」
Following the specific progress of SB623 being designated for the Sakigake designation system, the plan to submit an application for approval during the fiscal year ending January 2020 by utilizing the conditional and time-limited approval system is moving forward. - FY2019RestatedAnnual report
「For the chronic traumatic brain injury program in Japan, we aim to submit an application for marketing authorization as a regenerative medical product during the fiscal year ending January 2020 (February 2019 to January 2020), utilizing Japan’s conditional and time-limited approval system for regenerative medical products.」
The plan to pursue early practical use of SB623 in Japan by utilizing Japan’s conditional and time-limited approval system and submit an application for approval during the fiscal year ending January 2020 has been reaffirmed. - FY2019-Q3AdvancedAnnual report
「Accordingly, for the chronic-phase traumatic brain injury program in Japan, we aim to use the conditional and time-limited approval system for regenerative medical products in Japan and submit an application for marketing approval during the fiscal year ending January 2020.」
Following achievement of the primary endpoint in the chronic traumatic brain injury trial, the plan to submit an application for approval during the fiscal year ending January 2020 by utilizing the conditional and time-limited approval system has been reaffirmed, with specific progress reported. - FY2019-Q2RestatedAnnual report
「In particular, for the chronic-phase traumatic brain injury program in Japan, we aim to submit an application for marketing approval by using Japan's conditional and time-limited approval system for regenerative medical products. The application is scheduled to be submitted during the fiscal year ending January 2020.」
The plan to pursue early practical use of SB623 by utilizing Japan’s conditional and time-limited approval system and submit the application for approval during the fiscal year ending January 2020 has been reaffirmed. - FY2018Specification of target timingAnnual report
「Going forward, following a 6-month observation period, we will aim for the earliest commercialization among our SB623 programs by utilizing Japan’s conditional and time-limited expedited approval system. Specifically, we aim to announce the results during the fiscal year ending January 2019 and submit the application for approval during the fiscal year ending January 2020.」
The timing for the policy of achieving the earliest commercialization using Japan’s expedited approval system has been specified as a 6-month observation period, announcement of results during the fiscal year ending January 2019, and submission of the application for approval during the fiscal year ending January 2020. - FY2018-Q3RestatedAnnual report
「For this program, we aim to utilize the conditional and time-limited marketing authorization system for regenerative medical products launched under Japan’s revised Pharmaceutical Affairs Law, and are working toward bringing it into practical use in Japan ahead of anywhere else in the world.」
For the SB623 chronic traumatic brain injury program, the plan to pursue early practical use in Japan by utilizing Japan’s conditional and time-limited marketing authorization system has been reaffirmed. - FY2018-Q2RestatedAnnual report
「For this program, we aim to utilize the conditional and time-limited marketing authorization system for regenerative medical products launched under Japan’s revised Pharmaceutical Affairs Law, and are working toward bringing it into practical use in Japan ahead of anywhere else in the world.」
For the SB623 chronic traumatic brain injury program, the plan to pursue early practical use in Japan by utilizing Japan’s conditional and time-limited marketing authorization system has been reaffirmed. - FY2017First statedAnnual report
「In Japan, we plan to further accelerate development activities toward early commercialization, with a view to utilizing the expedited approval system for regenerative medical products.」
A plan has been presented to pursue early commercialization of SB623 in Japan by utilizing the expedited approval system for regenerative medical products.