Annuncio • Mar 17
SanBio Company Limited, Annual General Meeting, Apr 22, 2026 SanBio Company Limited, Annual General Meeting, Apr 22, 2026. Annuncio • Nov 07
SanBio Company Limited has filed a Follow-on Equity Offering in the amount of ¥14.922 billion. SanBio Company Limited has filed a Follow-on Equity Offering in the amount of ¥14.922 billion.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 6,000,000
Price\Range: ¥2487
Discount Per Security: ¥109.36 Annuncio • Oct 28
SanBio Company Limited to Report Q3, 2026 Results on Dec 15, 2025 SanBio Company Limited announced that they will report Q3, 2026 results on Dec 15, 2025 Annuncio • Sep 14
SanBio Company Limited to Report Q2, 2026 Results on Sep 12, 2025 SanBio Company Limited announced that they will report Q2, 2026 results on Sep 12, 2025 Annuncio • May 29
SanBio Co., Ltd. Announces Results of the Third Commercial Production Run to Meet the Approval Conditions for the Shipment of AKUUGO Suspension for Intracranial Implantation SanBio Co. Ltd. announced on April 18, 2025, that the expected yield from the third manufacturing of AKUUGO® Suspension for Intracranial Implantation was successfully secured, regarding the three production runs required for the release of shipments. The Company has completed specification testing and characteristic analysis for the third manufacturing run and has confirmed its results. The third manufacturing run cleared all specification requirements and was deemed compliant as well. With the fulfilment of the shipment conditions for AKUUGO, the company plans to promptly file a partial change application and proceed with obtaining full product approval. Annuncio • May 03
SanBio Company Limited to Report Q1, 2026 Results on Jun 13, 2025 SanBio Company Limited announced that they will report Q1, 2026 results on Jun 13, 2025 Annuncio • Feb 06
SanBio Company Limited Announces Results of the Second Commercial Production Run of AKUUGO SanBio Company Limited announced on December 6, 2024, that it had secured the planned production yield for the second commercial production run of AKUUGO® Suspension for Intracranial Implantation (INN: vandefitemcel), conducted to meet the shipment conditions required for obtaining product approval. The Company has completed specification testing and characteristic analysis for the second manufacturing run and has confirmed its results. The second manufacturing run cleared all specification requirements and was deemed compliant. The third manufacturing run has already commenced. With the compliance of this manufacturing run, the company will run one more manufacturing compliant with necessary specifications and plans to file a partial change application and subsequently obtain approval for the partial change to meet the shipment conditions. As a result, the anticipated timing for AKUUGO® to become eligible for shipment remains unchanged, with shipment expected to begin in the second quarter of the fiscal year ending January 31, 2026 (May-July 2025). AKUUGO suspension for intracranial implantation (INN: vandefitemcel) is a human (allogeneic) bone marrow-derived modified mesenchymal stem cell that is produced by modifying and culturing mesenchymal stem cells derived from the bone marrow aspirate of healthy adults. The transplantation of AKUUGO into damaged nerve tissues in the brain is expected to trigger the release of FGF-2 (a type of protein) and other substances, which in turn will promote the natural regenerative ability of damaged nerve cells and induce proliferation and differentiation of nerve cells. Annuncio • Jan 28
SanBio Company Limited to Report Fiscal Year 2025 Results on Mar 17, 2025 SanBio Company Limited announced that they will report fiscal year 2025 results on Mar 17, 2025 Annuncio • Dec 04
SanBio Company Limited announced that it expects to receive ¥1.99992672 billion in funding from Athos Capital Limited SanBio Company Limited announced a private placement to issue 2,295,600 common shares at issue price of ¥871.2 per share for gross proceeds of ¥1,999,926,720 on December 2, 2024. The transaction includes participation from new investor,Athos Asia Event Driven Master Fund. The transaction will happen through third party allocation. The issue date will be December 18, 2024. The transaction has been approved at board of director meeting of the company. The company will incur issuance cost of ¥98,996,000 and the net proceeds will be ¥1,900,930,720. Annuncio • Nov 17
SanBio Company Limited Announces the Results of the First Commercial Production Run of AKUUGO SanBio Co. Ltd. announced on July 31, 2024, that it had obtained conditional and time-limited approval for AKUUGO suspension for intracranial implantation from the Ministry of Health, Labour and Welfare and that it planned to conduct about two commercial production runs to meet the shipment conditions required under this approval. They hereby provide the results of the first production run. The first production run did not meet the specification standards. However, only one specification value was non-compliant, while all other specification values, including the yield--a key issue identified during the approval review process--were compliant. Moreover, the results of the characterization analysis were equivalent to those of the clinical trials product. They anticipated some non-conforming products due to batch-to-batch variability arising from the heterogeneity of cells, a critical raw material for AKUUGO®, and they consider the non-conformity of the first manufacturing lot to be within expectations. Regarding the outlook, since the manufacturing process has already been established and approved, they have commenced the second production run. After obtaining manufacturing results that conform to the specifications for the second time, they will file an application for a partial change and aim to obtain approval for the subsequent partial change. As a result, the expected timeline for completing the two commercial production runs required to begin shipments of AKUUGO® has been delayed by a quarter, from the first quarter of the fiscal year ending January 2026 (February-April 2025) to the second quarter of the same fiscal year (May-July 2025). This matter will have only a minimal impact on the financial performance of the current fiscal year. Annuncio • Oct 29
SanBio Company Limited to Report Q3, 2025 Results on Dec 16, 2024 SanBio Company Limited announced that they will report Q3, 2025 results on Dec 16, 2024 Annuncio • Jul 31
Sanbio Co., Ltd. Obtains Marketing Approval for AKUUGO Suspension for Intracranial Implantation SanBio Co. Ltd. announced that on July 31, 2024, it obtained conditional and time-limited marketing approval for the human somatic stem cell-processed product "AKUUGO suspension for intracranial implantation" in Japan, for the indication of improving chronic motor paralysis resulting from traumatic brain injury. Details of product overview and conditional and time-limited marketing approved for AKUUGO are provided in the attached reference material. The company expects shipment and sales to begin in the first quarter of the fiscal year ending January 31, 2026. Moreover, to satisfy the conditions for full approval, the company plan to conduct post-marketing clinical trials and other necessary studies within the seven-year marketing authorization period with the aim of obtaining full approval. Based on track record of having obtained conditional and time- limited marketing approval for AKUUGO, the company plan to reallocate resources concentrated on the SB623 program for TBI to expanding indications and regions for the product. Through AKUUGO, company hope to bring hope to the lives of as many TBI patients as possible. The approval of AKUUGO was based on the results of the global Phase 2 clinical trial SanBio conducted in Japan and the United States. Dr. Nobuhito Saito, Professor of Neurology at the University of Tokyo led the clinical trial, commented as follows. Thaw the cell suspension for intracranial implants, wash it with the dedicated preparation solution, and adjust the concentration of the cell suspension to 1.67 x 106 cells/100uL using the dedicated preparation solution. Cleanse the micro-syringe fixed with the cannula from the dedicated delivery device set with the dedicated preparation solution before filling it with the prepared cell suspension. Date of marketing approval, July 31, 2024, Product image, Vial containing cell suspension for intracraial implantation, Dry shipper, Hard case and dry shipper for transportation, Dedicated preparation solution, Dedicated preparation solution, dedicated preparation solution, Dedicated delivery device set, Outer package for dedicated delivery device set. Condition of approval. Considering the limited manufacturing record for the Product, the Company shall promptly collect information on the Product's quality based on a pre-determined plan, and evaluate and report on the equivalence/homogeneity, in terms of quality, of the investigational product (clinical trials product) and the Product intended for commercial distribution. Based on the evaluation results, the Company shall apply for a partial change of approved matters. It shall not ship the Product until the partial change application has been approved. The Company must ensure that the Product is used in medical facilities fully equipped to handle emergencies, by physicians who possess sufficient knowledge and experience in the diagnosis and treatment of traumatic brain injury and stereotactic treatment. Annuncio • Jul 27
SanBio Company Limited to Report Q2, 2025 Results on Sep 17, 2024 SanBio Company Limited announced that they will report Q2, 2025 results on Sep 17, 2024 Annuncio • Jun 13
SanBio Company Limited Announces Update on Status of Manufacturing and Marketing Approval for Sb623 Chronic Traumatic Brain Injury Program in Japan On March 26, 2024, SanBio Co. Ltd. (the "Company") provided an update on the progress toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan, stating it was concluded to continue the deliberation at a later date by the Pharmaceutical Affairs and Food Sanitation Council's Subcommittee on Regenerative Medicine Products (the "Subcommittee") and company planned to engage in further consultations with the regulatory authorities and to submit additional information such as additional data addressing quality. the Ministry of Health, Labour and Welfare announced that the Pharmaceutical Affairs and the Subcommittee will hold a meeting on June 19, and company learned that the Subcommittee will deliberate, among others, on whether to grant marketing approval for the regenerative medicine "AKUUGO suspension for intracranial implantation", whether to stipulate conditions and a time limit for the approval, and whether to designate a reexamination period. Accordingly, the Subcommittee will determine whether to grant the Company's development product SB623 marketing approval in the meeting. SB623 (INN: vandefitemcel) is a human (allogeneic) bone marrow-derived modified mesenchymal stem cell that is produced by modifying and culturing mesenchymal stem cells derived from the bone marrow aspirate of healthy adults. Implantation of SB623 cells into injured nerve tissues in the brain is expected to trigger the brain's natural regenerative ability to restore lost functions. SB623 is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and ischemic stroke. Annuncio • May 05
SanBio Company Limited to Report Q1, 2025 Results on Jun 13, 2024 SanBio Company Limited announced that they will report Q1, 2025 results on Jun 13, 2024 Annuncio • Mar 19
SanBio Company Limited, Annual General Meeting, Apr 24, 2024 SanBio Company Limited, Annual General Meeting, Apr 24, 2024. Agenda: To consider to reduce the amounts of stated capital and capital reserves and to make an appropriation of other capital surplus. Annuncio • Jan 28
SanBio Company Limited to Report Fiscal Year 2024 Results on Mar 18, 2024 SanBio Company Limited announced that they will report fiscal year 2024 results on Mar 18, 2024 Annuncio • Jan 25
Sanbio Co., Ltd. Provides Update on Status of Manufacturing and Marketing Approval for Sb623 Chronic Traumatic Brain Injury Program in Japan SanBio Co. Ltd. provided an update on the progress toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan, stating it aims to achieve approval by March 2024 and is actively engaged in the review process. Amidst this situation, the Ministry of Health, Labour and Welfare announced on January 22 that the Pharmaceutical Affairs and Food Sanitation Council's Subcommittee on Regenerative Medicine Products (the "Sub committee") would hold a meeting on February 5. However, developmental product SB623, which is undergoing approval review as a treatment for TBI under the framework of the Sakigake Designation System, was not included in the agenda for this meeting. Annuncio • Dec 14
SanBio Company Limited Provides Update on Status of Manufacturing and Marketing Approval for SB623 Chronic Traumatic Brain Injury (TBI) Program in Japan SanBio Company Limited provided an update on the progress toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan, stating that the Company was focused on resolving the issue related to the production yield and responding to production-related review by regulatory authorities, with the goal of obtaining approval by the end of the current fiscal year. The Company hereby provides another progress update, to ensure timely disclosure to concerned patients and their families, as well as shareholders and investors who await the approval of SB623. SB623 is undergoing approval review under the framework of the Sakigake Designation System as a treatment for chronic effects associated with TBI. The production yield-related issue has been resolved, and the review process is proceeding to a conclusion. However, given the status of the review process, it will take some more time until approval is granted, and for this reason, the Company now expects to obtain approval in March 2024. Although the timing of approval is outside of the Company's control, SanBio will continue to work as one and do utmost to obtain approval. Annuncio • Oct 14
SanBio Company Limited to Report Q3, 2024 Results on Dec 14, 2023 SanBio Company Limited announced that they will report Q3, 2024 results on Dec 14, 2023 Annuncio • Jul 29
SanBio Company Limited to Report Q2, 2024 Results on Sep 15, 2023 SanBio Company Limited announced that they will report Q2, 2024 results on Sep 15, 2023 Annuncio • May 13
SanBio Company Limited to Report Q1, 2024 Results on Jun 14, 2023 SanBio Company Limited announced that they will report Q1, 2024 results on Jun 14, 2023 Annuncio • Feb 03
SanBio Company Limited to Report Fiscal Year 2023 Results on Mar 16, 2023 SanBio Company Limited announced that they will report fiscal year 2023 results on Mar 16, 2023 Annuncio • Jan 20
SanBio Co., Ltd. Announces Board Changes SanBio Co. Ltd. announced that at a meeting held on January 20, 2023, its Board of Directors resolved to make the following changes to senior management (representative director and corporate officer). Representative Director, Executive Vice President, and COO Akihiro Tsujimura has submitted his resignation for personal reasons and the Company has accepted it. Due to the resignation of Mr. Tsujimura, Corporate Officer and Business Head (Japan/Asia) Naoki Tsukahara will be appointed executive corporate officer responsible for HR, Japan Regulatory Affairs & Quality Compliance Japan, and Japan/Asia business, and will take over some of the responsibilities of Mr. Tsujimura. Effective date of change is January 20, 2023. 
