View ValuationSanBio 향후 성장Future 기준 점검 6/6SanBio (는) 각각 연간 52.6% 및 38.4% 수익과 수익이 증가할 것으로 예상됩니다. EPS는 연간 18.1% 만큼 성장할 것으로 예상됩니다. 자기자본이익률은 3년 후 53.2% 로 예상됩니다.핵심 정보52.6%이익 성장률18.08%EPS 성장률Biotechs 이익 성장25.2%매출 성장률38.4%향후 자기자본이익률53.21%애널리스트 커버리지Low마지막 업데이트26 Mar 2026최근 향후 성장 업데이트업데이트 없음모든 업데이트 보기Recent updates공시 • Mar 17SanBio Company Limited, Annual General Meeting, Apr 22, 2026SanBio Company Limited, Annual General Meeting, Apr 22, 2026.공시 • Nov 07SanBio 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: ¥109.36공시 • Oct 28SanBio Company Limited to Report Q3, 2026 Results on Dec 15, 2025SanBio Company Limited announced that they will report Q3, 2026 results on Dec 15, 2025공시 • Sep 14SanBio Company Limited to Report Q2, 2026 Results on Sep 12, 2025SanBio Company Limited announced that they will report Q2, 2026 results on Sep 12, 2025공시 • May 29SanBio Co., Ltd. Announces Results of the Third Commercial Production Run to Meet the Approval Conditions for the Shipment of AKUUGO Suspension for Intracranial ImplantationSanBio 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.공시 • May 03SanBio Company Limited to Report Q1, 2026 Results on Jun 13, 2025SanBio Company Limited announced that they will report Q1, 2026 results on Jun 13, 2025공시 • Mar 17+ 1 more updateSanBio Company Limited, Annual General Meeting, Apr 23, 2025SanBio Company Limited, Annual General Meeting, Apr 23, 2025.공시 • Feb 06SanBio Company Limited Announces Results of the Second Commercial Production Run of AKUUGOSanBio 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.공시 • Jan 28SanBio Company Limited to Report Fiscal Year 2025 Results on Mar 17, 2025SanBio Company Limited announced that they will report fiscal year 2025 results on Mar 17, 2025공시 • Dec 04SanBio Company Limited announced that it expects to receive ¥1.99992672 billion in funding from Athos Capital LimitedSanBio 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.공시 • Nov 17SanBio Company Limited Announces the Results of the First Commercial Production Run of AKUUGOSanBio 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.공시 • Oct 29SanBio Company Limited to Report Q3, 2025 Results on Dec 16, 2024SanBio Company Limited announced that they will report Q3, 2025 results on Dec 16, 2024공시 • Jul 31Sanbio Co., Ltd. Obtains Marketing Approval for AKUUGO Suspension for Intracranial ImplantationSanBio 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.공시 • Jul 27SanBio Company Limited to Report Q2, 2025 Results on Sep 17, 2024SanBio Company Limited announced that they will report Q2, 2025 results on Sep 17, 2024공시 • Jun 13SanBio Company Limited Announces Update on Status of Manufacturing and Marketing Approval for Sb623 Chronic Traumatic Brain Injury Program in JapanOn 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.공시 • May 05SanBio Company Limited to Report Q1, 2025 Results on Jun 13, 2024SanBio Company Limited announced that they will report Q1, 2025 results on Jun 13, 2024공시 • Mar 19SanBio Company Limited, Annual General Meeting, Apr 24, 2024SanBio 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.공시 • Jan 28SanBio Company Limited to Report Fiscal Year 2024 Results on Mar 18, 2024SanBio Company Limited announced that they will report fiscal year 2024 results on Mar 18, 2024공시 • Jan 25Sanbio Co., Ltd. Provides Update on Status of Manufacturing and Marketing Approval for Sb623 Chronic Traumatic Brain Injury Program in JapanSanBio 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.공시 • Dec 14SanBio Company Limited Provides Update on Status of Manufacturing and Marketing Approval for SB623 Chronic Traumatic Brain Injury (TBI) Program in JapanSanBio 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.공시 • Oct 14SanBio Company Limited to Report Q3, 2024 Results on Dec 14, 2023SanBio Company Limited announced that they will report Q3, 2024 results on Dec 14, 2023공시 • Jul 29SanBio Company Limited to Report Q2, 2024 Results on Sep 15, 2023SanBio Company Limited announced that they will report Q2, 2024 results on Sep 15, 2023공시 • Jun 15+ 1 more updateSanBio Co., Ltd. Updates on Status of Manufacturing and Marketing Approval for SB623 Chronic Traumatic Brain Injury Program in JapanSanBio Co. Ltd. announced that it was working to resolve the issue of production yield, to bring yield back to the level at the time of application filing toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan during the current fiscal year ending January 2024. The Company announced that whether the issue is resolved should be known by June 2023 and will be reported at the result briefing for the first quarter of the fiscal year ending January 2024. The Company hereby provides a progress update, to ensure timely disclosure to concerned patients, their families, as well as shareholders and investors who await the approval of SB623. SB623 is under review in the Sakigake Designation System for approval as a treatment for chronic effects associated with TBI. Toward obtaining approval, the Company is currently focused on resolving the issue related to the production yield and responding to production-related review. Although the company have yet to fully recover the production yield obtained at the time of application filing, additional data from the latest production run has led to measures that could resolve the yield-related issue. A production run with implemented measures is currently underway, and results are expected in August. Although the timing of approval is outside of the Company's control, by resolving the yield-related issue and responding to production-related review in a timely manner, presently the Company's goal remains to obtain approval during the current fiscal year. 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. Traumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. The estimated global incidence of acute TBI during 2016 was 27 million cases, and the estimated global prevalence of chronic impairment secondary to TBI was 55.5 million cases. Overall, TBI and long-term motor deficits secondary to TBI significantly impair a person's self-care, employability, and quality of life, and are major burdens on healthcare systems worldwide. In the United States, approximately 43% of surviving hospitalized persons with TBI experience long-term disabilities, and it is estimated that 3.17 million people are living with long-term disabilities secondary to TBI.공시 • May 13SanBio Company Limited to Report Q1, 2024 Results on Jun 14, 2023SanBio Company Limited announced that they will report Q1, 2024 results on Jun 14, 2023공시 • Feb 03SanBio Company Limited to Report Fiscal Year 2023 Results on Mar 16, 2023SanBio Company Limited announced that they will report fiscal year 2023 results on Mar 16, 2023공시 • Jan 20SanBio Co., Ltd. Announces Board ChangesSanBio 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.이익 및 매출 성장 예측OTCPK:SNBI.F - 애널리스트 향후 추정치 및 과거 재무 데이터 (JPY Millions)날짜매출이익자유현금흐름영업현금흐름평균 애널리스트 수1/31/202930,7037,510N/AN/A31/31/202819,2693,45826426951/31/20273,418-3,08465365851/31/2026N/A-3,842-3,792-3,760N/A10/31/2025N/A-3,444N/AN/AN/A7/31/2025N/A-3,570-3,955-3,952N/A4/30/2025N/A-4,270N/AN/AN/A1/31/2025N/A-2,882-3,607-3,603N/A10/31/2024N/A-2,914N/AN/AN/A7/31/2024N/A-2,166-3,880-3,831N/A4/30/2024N/A-2,162N/AN/AN/A1/31/2024N/A-2,644-4,819-4,765N/A10/31/2023N/A-5,684N/AN/AN/A7/31/2023N/A-5,192-6,106-6,094N/A4/30/2023N/A-5,870N/AN/AN/A1/31/2023N/A-5,559-7,441-7,434N/A10/31/2022N/A-3,320N/AN/AN/A7/31/2022N/A-4,697-7,080-7,048N/A4/30/2022N/A-4,132N/AN/AN/A1/31/2022N/A-4,677-6,602-6,546N/A10/31/2021N/A-1,659N/AN/AN/A7/31/2021N/A-2,312-6,267-6,189N/A4/30/2021N/A-2,738N/AN/AN/A1/31/2021N/A-3,385-5,353-5,215N/A10/31/202023-6,718N/AN/AN/A7/31/202020-6,316-5,619-5,430N/A4/30/2020258-5,928N/AN/AN/A1/31/2020447-5,157-5,823-5,717N/A10/31/2019597-4,651N/AN/AN/A7/31/2019753-3,927N/A-4,619N/A4/30/2019772-2,819N/AN/AN/A1/31/2019741-2,920N/A-3,968N/A10/31/2018687-2,331N/AN/AN/A7/31/2018656-2,705N/A-2,107N/A4/30/2018525-3,680N/AN/AN/A1/31/2018490-3,940N/A-1,906N/A10/31/2017562-3,302N/AN/AN/A7/31/2017514-2,966N/A-3,099N/A4/30/2017447-2,655N/AN/AN/A1/31/2017949-1,835N/A-1,796N/A10/31/2016833-2,209N/AN/AN/A7/31/20161,447-1,693N/A-1,290N/A4/30/20161,515-1,156N/AN/AN/A1/31/20161,174-988N/A-1,362N/A10/31/20151,208-647N/AN/AN/A더 보기애널리스트 향후 성장 전망수입 대 저축률: SNBI.F 은 향후 3년 동안 수익을 낼 것으로 예상되며, 이는 절약률(3.4%)보다 빠른 성장으로 간주됩니다.수익 vs 시장: SNBI.F (는) 향후 3년 동안 평균 시장 성장보다 높은 수익을 올릴 것으로 예상됩니다.고성장 수익: SNBI.F 향후 3년 내에 수익을 낼 것으로 예상됩니다.수익 대 시장: SNBI.F 의 수익(연간 38.4%)이 US 시장(연간 11.7%)보다 빠르게 성장할 것으로 예상됩니다.고성장 매출: SNBI.F 의 수익(연간 38.4%)은 연간 20%보다 빠르게 증가할 것으로 예상됩니다.주당순이익 성장 예측향후 자기자본이익률미래 ROE: SNBI.F의 자본 수익률은 3년 후 53.2%로 매우 높을 것으로 예상됩니다.성장 기업 찾아보기7D1Y7D1Y7D1YPharmaceuticals-biotech 산업의 고성장 기업.View Past Performance기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/03/29 07:15종가2025/12/30 00:00수익2026/01/31연간 수익2026/01/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스SanBio Company Limited는 10명의 분석가가 다루고 있습니다. 이 중 5명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Hidemaru YamaguchiCitigroup IncStephen BarkerJefferies LLCMiyabi YamakitaJefferies LLC7명의 분석가 더 보기
공시 • Mar 17SanBio Company Limited, Annual General Meeting, Apr 22, 2026SanBio Company Limited, Annual General Meeting, Apr 22, 2026.
공시 • Nov 07SanBio 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
공시 • Oct 28SanBio Company Limited to Report Q3, 2026 Results on Dec 15, 2025SanBio Company Limited announced that they will report Q3, 2026 results on Dec 15, 2025
공시 • Sep 14SanBio Company Limited to Report Q2, 2026 Results on Sep 12, 2025SanBio Company Limited announced that they will report Q2, 2026 results on Sep 12, 2025
공시 • May 29SanBio Co., Ltd. Announces Results of the Third Commercial Production Run to Meet the Approval Conditions for the Shipment of AKUUGO Suspension for Intracranial ImplantationSanBio 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.
공시 • May 03SanBio Company Limited to Report Q1, 2026 Results on Jun 13, 2025SanBio Company Limited announced that they will report Q1, 2026 results on Jun 13, 2025
공시 • Mar 17+ 1 more updateSanBio Company Limited, Annual General Meeting, Apr 23, 2025SanBio Company Limited, Annual General Meeting, Apr 23, 2025.
공시 • Feb 06SanBio Company Limited Announces Results of the Second Commercial Production Run of AKUUGOSanBio 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.
공시 • Jan 28SanBio Company Limited to Report Fiscal Year 2025 Results on Mar 17, 2025SanBio Company Limited announced that they will report fiscal year 2025 results on Mar 17, 2025
공시 • Dec 04SanBio Company Limited announced that it expects to receive ¥1.99992672 billion in funding from Athos Capital LimitedSanBio 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.
공시 • Nov 17SanBio Company Limited Announces the Results of the First Commercial Production Run of AKUUGOSanBio 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.
공시 • Oct 29SanBio Company Limited to Report Q3, 2025 Results on Dec 16, 2024SanBio Company Limited announced that they will report Q3, 2025 results on Dec 16, 2024
공시 • Jul 31Sanbio Co., Ltd. Obtains Marketing Approval for AKUUGO Suspension for Intracranial ImplantationSanBio 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.
공시 • Jul 27SanBio Company Limited to Report Q2, 2025 Results on Sep 17, 2024SanBio Company Limited announced that they will report Q2, 2025 results on Sep 17, 2024
공시 • Jun 13SanBio Company Limited Announces Update on Status of Manufacturing and Marketing Approval for Sb623 Chronic Traumatic Brain Injury Program in JapanOn 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.
공시 • May 05SanBio Company Limited to Report Q1, 2025 Results on Jun 13, 2024SanBio Company Limited announced that they will report Q1, 2025 results on Jun 13, 2024
공시 • Mar 19SanBio Company Limited, Annual General Meeting, Apr 24, 2024SanBio 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.
공시 • Jan 28SanBio Company Limited to Report Fiscal Year 2024 Results on Mar 18, 2024SanBio Company Limited announced that they will report fiscal year 2024 results on Mar 18, 2024
공시 • Jan 25Sanbio Co., Ltd. Provides Update on Status of Manufacturing and Marketing Approval for Sb623 Chronic Traumatic Brain Injury Program in JapanSanBio 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.
공시 • Dec 14SanBio Company Limited Provides Update on Status of Manufacturing and Marketing Approval for SB623 Chronic Traumatic Brain Injury (TBI) Program in JapanSanBio 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.
공시 • Oct 14SanBio Company Limited to Report Q3, 2024 Results on Dec 14, 2023SanBio Company Limited announced that they will report Q3, 2024 results on Dec 14, 2023
공시 • Jul 29SanBio Company Limited to Report Q2, 2024 Results on Sep 15, 2023SanBio Company Limited announced that they will report Q2, 2024 results on Sep 15, 2023
공시 • Jun 15+ 1 more updateSanBio Co., Ltd. Updates on Status of Manufacturing and Marketing Approval for SB623 Chronic Traumatic Brain Injury Program in JapanSanBio Co. Ltd. announced that it was working to resolve the issue of production yield, to bring yield back to the level at the time of application filing toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan during the current fiscal year ending January 2024. The Company announced that whether the issue is resolved should be known by June 2023 and will be reported at the result briefing for the first quarter of the fiscal year ending January 2024. The Company hereby provides a progress update, to ensure timely disclosure to concerned patients, their families, as well as shareholders and investors who await the approval of SB623. SB623 is under review in the Sakigake Designation System for approval as a treatment for chronic effects associated with TBI. Toward obtaining approval, the Company is currently focused on resolving the issue related to the production yield and responding to production-related review. Although the company have yet to fully recover the production yield obtained at the time of application filing, additional data from the latest production run has led to measures that could resolve the yield-related issue. A production run with implemented measures is currently underway, and results are expected in August. Although the timing of approval is outside of the Company's control, by resolving the yield-related issue and responding to production-related review in a timely manner, presently the Company's goal remains to obtain approval during the current fiscal year. 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. Traumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. The estimated global incidence of acute TBI during 2016 was 27 million cases, and the estimated global prevalence of chronic impairment secondary to TBI was 55.5 million cases. Overall, TBI and long-term motor deficits secondary to TBI significantly impair a person's self-care, employability, and quality of life, and are major burdens on healthcare systems worldwide. In the United States, approximately 43% of surviving hospitalized persons with TBI experience long-term disabilities, and it is estimated that 3.17 million people are living with long-term disabilities secondary to TBI.
공시 • May 13SanBio Company Limited to Report Q1, 2024 Results on Jun 14, 2023SanBio Company Limited announced that they will report Q1, 2024 results on Jun 14, 2023
공시 • Feb 03SanBio Company Limited to Report Fiscal Year 2023 Results on Mar 16, 2023SanBio Company Limited announced that they will report fiscal year 2023 results on Mar 16, 2023
공시 • Jan 20SanBio Co., Ltd. Announces Board ChangesSanBio 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.