SanBio（SNBO.Y）株式概要サンバイオ株式会社は、中枢神経系再生細胞医薬品の開発・製造・販売を行っている。 詳細SNBO.Y ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長2/6過去の実績0/6財務の健全性4/6配当金0/6報酬収益は年間55.07%増加すると予測されています 過去5年間の収益は年間2.2%増加しました。 リスク分析今後3年間の収益は年平均2.2%減少すると予測されている。 株式の流動性は非常に低い 収益が 100 万ドル未満 ( ¥0 )現在は利益が出ておらず、今後3年間で利益が出る見込みはない +2 さらなるリスクすべてのリスクチェックを見るSNBO.Y Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$2.81該当なし内在価値ディスカウントEst. Revenue$PastFuture-6b3b2016201920222025202620282031Revenue JP¥9.0Earnings JP¥1.6AdvancedSet Fair ValueView all narrativesSanBio Company Limited 競合他社Ovid TherapeuticsSymbol: NasdaqCM:OVIDMarket cap: US$437.8mvTv TherapeuticsSymbol: NasdaqCM:VTVTMarket cap: US$411.5mPrelude TherapeuticsSymbol: NasdaqGS:PRLDMarket cap: US$411.4mMonopar TherapeuticsSymbol: NasdaqCM:MNPRMarket cap: US$419.5m価格と性能株価の高値、安値、推移の概要SanBio過去の株価現在の株価JP¥2.8152週高値JP¥5.4852週安値JP¥2.81ベータ0.391ヶ月の変化0%3ヶ月変化n/a1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化-39.54%最新ニュースお知らせ • Mar 17SanBio Company Limited, Annual General Meeting, Apr 22, 2026SanBio Company Limited, Annual General Meeting, Apr 22, 2026.お知らせ • 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お知らせ • 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お知らせ • 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お知らせ • 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.お知らせ • 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最新情報をもっと見るRecent updatesお知らせ • Mar 17SanBio Company Limited, Annual General Meeting, Apr 22, 2026SanBio Company Limited, Annual General Meeting, Apr 22, 2026.お知らせ • 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お知らせ • 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お知らせ • 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お知らせ • 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.お知らせ • 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お知らせ • Mar 17+ 1 more updateSanBio Company Limited, Annual General Meeting, Apr 23, 2025SanBio Company Limited, Annual General Meeting, Apr 23, 2025.お知らせ • 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.お知らせ • 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お知らせ • 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.お知らせ • 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.お知らせ • 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お知らせ • 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.お知らせ • 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お知らせ • 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.お知らせ • 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お知らせ • 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.株主還元SNBO.YUS BiotechsUS 市場7D0%1.0%1.3%1Yn/a34.2%27.7%株主還元を見る業界別リターン: SNBO.YがUS Biotechs業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: SNBO.Y US市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is SNBO.Y's price volatile compared to industry and market?SNBO.Y volatilitySNBO.Y Average Weekly Movementn/aBiotechs Industry Average Movement10.9%Market Average Movement7.2%10% most volatile stocks in US Market16.6%10% least volatile stocks in US Market3.0%安定した株価: SNBO.Y 、 US市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: 過去 1 年間のSNBO.Yのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト200129Keita Moriwww.sanbio.comサンバイオ株式会社は、中枢神経系の再生細胞医薬品の開発、製造、販売を行っている。同社はSB623を開発し、米国と日本で外傷性脳損傷を対象とした第2相臨床試験を完了した。同社の研究パイプラインには、虚血性・出血性脳卒中、加齢黄斑変性、網膜色素変性、パーキンソン病、脊髄損傷、アルツハイマー病に対するSB623、末梢神経損傷に対するSB618、筋ジストロフィー疾患に対するSB308、がんに対するMSC1、炎症性疾患や視神経炎に対するMSC2がある。同社は2001年に設立され、東京に本社を置いている。もっと見るSanBio Company Limited 基礎のまとめSanBio の収益と売上を時価総額と比較するとどうか。SNBO.Y 基礎統計学時価総額US$427.31m収益（TTM）-US$13.45m売上高(TTM)n/a0.0xP/Sレシオ-31.8xPER（株価収益率SNBO.Y は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計SNBO.Y 損益計算書（TTM）収益JP¥0売上原価JP¥0売上総利益JP¥0その他の費用JP¥2.16b収益-JP¥2.16b直近の収益報告Apr 30, 2024次回決算日該当なし一株当たり利益（EPS）-31.50グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率24.9%SNBO.Y の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2024/07/07 02:24終値2024/04/09 00:00収益2024/04/30年間収益2024/01/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋SanBio Company Limited 5 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。10 アナリスト機関Hidemaru YamaguchiCitigroup IncStephen BarkerJefferies LLCMiyabi YamakitaJefferies LLC7 その他のアナリストを表示
お知らせ • Mar 17SanBio Company Limited, Annual General Meeting, Apr 22, 2026SanBio Company Limited, Annual General Meeting, Apr 22, 2026.
お知らせ • 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
お知らせ • 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
お知らせ • 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
お知らせ • 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.
お知らせ • 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
お知らせ • Mar 17SanBio Company Limited, Annual General Meeting, Apr 22, 2026SanBio Company Limited, Annual General Meeting, Apr 22, 2026.
お知らせ • 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
お知らせ • 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
お知らせ • 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
お知らせ • 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.
お知らせ • 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
お知らせ • Mar 17+ 1 more updateSanBio Company Limited, Annual General Meeting, Apr 23, 2025SanBio Company Limited, Annual General Meeting, Apr 23, 2025.
お知らせ • 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.
お知らせ • 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
お知らせ • 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.
お知らせ • 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.
お知らせ • 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
お知らせ • 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.
お知らせ • 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
お知らせ • 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.
お知らせ • 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
お知らせ • 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.
