Establishment of the Manufacturing, Logistics and Sales Framework for SB623 After Commercialization
First written in FY2018. 31 of 47 entries say "Advanced", first in FY2019-Q3. Latest entry: 2026-10-05.
2 other companies' latest entry also says "Advanced".
- FY2027-H1AdvancedAnnual report
「Following the start of sales, we are providing information to healthcare professionals through lectures and other activities to promote the proper use of Acugo® and are building a stable supply system.」
After the launch of アクーゴ®, the Company moved into the stage of operating and maintaining systems for providing information to healthcare professionals and ensuring stable supply. - FY2026AdvancedAnnual report
「The first shipment of アクーゴ® is scheduled for the following fiscal year. The manufacturing, logistics and sales structures established to date will be put into operation, and full-scale operations will be conducted successfully.」
The manufacturing, logistics and sales structures are planned to move from the establishment stage to the full-scale operating stage accompanying the first shipment of アクーゴ®. - FY2026-H1AdvancedAnnual report
「The Company subsequently manufactured the commercial product to obtain compliance in approximately 2 manufacturing runs in order to confirm comparability and consistency, one of the approval conditions. The 2 manufacturing runs have already met all specification test and characterization criteria and have been determined to be compliant. Following this result, in June 2025 the Company completed an application for partial changes to the marketing approval particulars for アクーゴ®. The Company currently expects to obtain approval in the second half of the fiscal year ending January 2026 (August 2025-January 2026), following the regulatory review and committee deliberations. アクーゴ® is scheduled to be launched after its inclusion in the NHI drug price list.」
Following compliance in 2 commercial product manufacturing runs and completion of the application for partial changes to the approved particulars, the manufacturing, logistics and sales structure moved into the stage of preparing for launch after approval is obtained in the second half of the fiscal year ending January 2026 and inclusion in the NHI drug price list. - FY2025AdvancedAnnual report
「If the results are deemed compliant, the Company will use them to apply for partial changes to the marketing approval particulars and seek approval to lift the shipment restrictions. At the same time, it will steadily proceed with establishing domestic manufacturing, logistics and sales structures.」
The process for the post-marketing structure for アクーゴ® has been specified, with the second commercial product manufacturing compliance assessment, application for partial changes, approval to lift the shipment restrictions, and establishment of domestic manufacturing, logistics and sales structures to proceed in parallel after the first commercial product manufacturing compliance assessment. - FY2025-H1AdvancedAnnual report
「To satisfy the conditions relating to the shipment, the Group will promptly manufacture approximately 2 batches of commercial product, confirm the comparability and consistency of the investigational product and the commercial product, and, based on the results, apply for inclusion in the National Health Insurance drug price list and for partial changes to the approved particulars. To enable shipment as soon as possible, the Group is proceeding with commercial product manufacturing on the assumption that shipment will become possible in the first quarter of the fiscal year ending January 2026 (February-April 2025).」
A specific process was presented for establishing the post-marketing structure for アクーゴ®, including commercial product manufacturing to satisfy the approval conditions, confirmation of comparability and consistency, NHI drug price listing, and an application for partial changes to the approved particulars, with the aim of enabling shipment in the first quarter of the fiscal year ending January 2026. - FY2024RestatedAnnual report
「In parallel, the Company will proceed with establishing manufacturing, logistics and sales structures for the domestic rollout of SB623 after approval.」
The policy of proceeding in parallel with the approval process to establish manufacturing, logistics and sales structures for the domestic rollout of SB623 after approval was reaffirmed. - FY2024-Q3RestatedAnnual report
「The Company is currently responding to the PMDA review while steadily preparing to establish a sales structure so that it can begin marketing promptly after approval is obtained.」
The company continues to prepare to establish a sales system so that sales can begin promptly after SB623 approval. - FY2024-Q2RestatedAnnual report
「The company is steadily advancing preparations to establish a sales system so that sales can begin promptly after approval.」
The company continues to prepare to establish a sales system so that sales can begin promptly after SB623 approval. - FY2024-Q1RestatedAnnual report
「The company is steadily advancing preparations to establish a sales system so that sales can begin promptly after approval.」
The company continues to prepare to establish a sales system so that sales can begin promptly after SB623 approval. - FY2023RestatedAnnual report
「The Company will continue to establish a stable supply system, including the joint development with SUZUKEN CO.,LTD. of the R-SAT system, a distribution management system designed to ensure reliable delivery of products to patients under strict quality control. It will also work to establish a system promoting appropriate use, including the preparation of materials providing product information to medical institutions, development of a system for distributing those materials, and development of a patient eligibility assessment system.」
The company continues to establish systems for stable supply and appropriate use after approval, including joint development of the R-SAT system with SUZUKEN CO.,LTD., provision of information to medical institutions and a patient eligibility assessment system. - FY2023-Q3AdvancedAnnual report
「① Establishment of the manufacturing system and inventory buildup after the launch of the SB623 chronic traumatic brain injury program 6,846 November 2022-November 2024／② Costs of establishing the post-launch distribution system and promoting distribution activities for the SB623 chronic traumatic brain injury program 2,110 November 2022-November 2024」
A specific plan was presented to allocate the proceeds from the 34th Stock Acquisition Rights to manufacturing, inventory buildup and establishment of a distribution system for SB623 after commercialization. - 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 policy of preparing to establish a sales system in order to begin sales promptly after SB623 approval has been reconfirmed. - 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.」
Regarding the post-commercialization sales system for SB623, the policy of preparing for a prompt sales launch after approval in parallel with responding to the PMDA review has been reconfirmed. - FY2022AdvancedAnnual report
「Based on the progress of the domestic SB623 chronic traumatic brain injury program described above, we have begun establishing the manufacturing, logistics and sales systems needed to ensure a stable supply and appropriate use of regenerative medical products, which differ in nature from conventional pharmaceuticals.」
Following completion of the domestic marketing authorization application, the company has begun establishing post-commercialization manufacturing, logistics and sales systems and is advancing concrete preparations, including the R-SAT system, product information provision and patient eligibility assessment. - FY2022-Q3AdvancedAnnual report
「The company entered into the commitment line agreement below with Resona Bank to fund the establishment of post-launch manufacturing, logistics and sales systems for SB623. 1. Borrowing limit: ¥1,000 million 2. Agreement date: 15 December 2021 3. Commitment period: 14 January 2022 to 30 June 2023」
A ¥1,000 million commitment line agreement was newly signed with Resona Bank to establish manufacturing, logistics and sales systems after SB623 commercialization. - 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 continuing preparations to establish a sales system following SB623 approval has been reconfirmed, but no new specific milestones have been presented. - FY2021AdvancedAnnual report
「In February 2021, the company established a subsidiary in Singapore in preparation for a global supply chain for the group's regenerative cell therapy products, including SB623, expansion of sales territories in Asia and business development activities.」
The establishment of a Singapore subsidiary focused on Asian expansion and a global supply chain was achieved as part of efforts to establish global post-commercialization supply and sales systems. - FY2021-Q3RestatedAnnual report
「During the third quarter of the consolidated cumulative period, manufacturing-related costs associated with the marketing authorization application for the SB623 chronic traumatic brain injury program were the main expense item」
Manufacturing-related preparations and expenditures for SB623's domestic marketing authorization application are continuing, and the policy of establishing a post-commercialization manufacturing and supply system has been reconfirmed. - FY2021-Q2AdvancedAnnual report
「In parallel, preparations for domestic commercialization of SB623 are progressing smoothly, and a system centered on the Medical Affairs division to support medical institutions is taking shape.」
Specific progress was reported on preparations for domestic commercialization of SB623, with a system centered on the Medical Affairs division to support medical institutions still under development. - FY2021-Q1RestatedAnnual report
「During the first quarter of the consolidated cumulative period, manufacturing-related costs associated with the marketing authorization application for the SB623 chronic traumatic brain injury program were the main expense item」
Manufacturing-related preparations and expenditures for the domestic marketing authorization application are continuing, and the policy of establishing a post-commercialization manufacturing and supply system has been reconfirmed. - FY2020AdvancedAnnual report
「In parallel, as part of preparations to establish distribution and sales systems, the company has agreed with SUZUKEN CO.,LTD. to enter into a basic transaction agreement concerning the commercial flow for supplying regenerative cell therapy products and to jointly develop and begin implementing the R-SAT system, which provides end-to-end management from traceability through delivery of regenerative cell therapy products to patients to post-administration patient support.」
Regarding the post-commercialization system, concrete steps are under way to establish manufacturing, logistics, sales and patient support capabilities, including manufacturing outsourcing with Hitachi Chemical, a basic distribution agreement with SUZUKEN CO.,LTD., and the launch of joint development of the R-SAT system. - FY2020-Q3RestatedAnnual report
「To allow sufficient time to prepare for commercial product manufacturing and fulfill the responsibility of ensuring a stable supply after commercialization」
The policy of prioritizing production preparations for SB623 commercialization and establishing a stable supply system has been reconfirmed as the reason for reviewing the timing of the marketing authorization application. - FY2020-Q2AdvancedAnnual report
「In parallel, efforts are also under way in preparation for commercialization, and in August 2019 the company entered into a basic agreement with SUZUKEN CO.,LTD. concerning the distribution and commercial flow of regenerative cell therapy products.」
Regarding the post-commercialization distribution and sales system, the company entered into a basic agreement with SUZUKEN CO.,LTD. in August 2019 concerning the commercial flow for distributing regenerative cell therapy products. - FY2020-Q1AdvancedAnnual report
「This financing was undertaken in anticipation of demand for SB623 sales in Japan, the United States and Europe. The funds are planned to be allocated to diversifying contract manufacturers and securing SB623 inventory in order to increase mass-production capacity and establish a stable supply system.」
Regarding the post-commercialization supply system for SB623, specific preparations and uses of funds were presented, including increasing mass-production capacity, diversifying contract manufacturers and securing inventory. - FY2019AdvancedAnnual report
「As part of preparations to establish the manufacturing system, the company entered into a manufacturing outsourcing partnership with Hitachi Chemical Co., Ltd. and, as part of preparations to establish distribution and sales systems, began joint research with CareNet, Inc. and 3 other companies.」
Regarding the establishment of the post-commercialization system for SB623, the company confirmed its manufacturing outsourcing partnership with Hitachi Chemical and the launch of joint research with CareNet and 3 other companies to establish distribution and sales systems. - FY2019-Q3AdvancedAnnual report
「As part of preparations to establish distribution and sales systems, the company has decided to conduct joint research with CareNet, Inc. and 3 other companies and has begun these efforts.」
To establish distribution and sales systems for SB623, the company decided to conduct joint research with CareNet and 3 other companies and began these efforts. - FY2019-Q2RestatedAnnual report
「The funds raised are planned to be allocated to growth initiatives, including ① establishing manufacturing, logistics and sales systems after SB623 commercialization, ② research and development related to the chronic ischemic stroke program in Japan and regional expansion ahead of future sales of SB623, and ③ research and development to expand SB623 into new indications and introduce new substances.」
The use of proceeds from the 13th Stock Acquisition Rights has reconfirmed the establishment of manufacturing, logistics and sales systems after SB623 commercialization. - FY2018First statedAnnual report
「We will work to establish manufacturing and quality control systems capable of supporting global operations, including manufacturing systems and capacity to stably supply substantial quantities of the cell therapy to medical institutions, particularly once marketing in Japan becomes possible, as well as logistics and sales systems to ensure smooth product delivery to medical institutions.」
Separate from establishing commercial-scale production technology, the company identified the establishment of global manufacturing, quality control, logistics and sales systems in preparation for commercialization as a key issue. The post-filing use of funds also included a plan to allocate ¥8,000 million to establishing these systems from April 2018 to January 2022.