Company Profile

About Us

Company Profile

Company Name
SanBio Company Limited
SanBio, Inc. Founded
February 2001
SanBio, Ltd. Established
February 2013
Representative
Directors
Keita Mori, President
Toru Kawanishi, Executive Chairman
Founding Scientist
Dr. Hideyuki Okano, Professor of Keio Medical School
Headquarters
St. Luke Tower 13F, 8-1 Akashi-cho, Chuo-ku, Tokyo, 104-0044
Subsidiaries
SanBio, Inc. ( 231 S. Whisman Road, Mountain View, CA, 94041-1522 USA )
SanBio Asia Pte. Ltd. ( 105 Cecil Street #07-03 Singapore 069534 )
Scope of Business
Development, production and sales of regenerative cell medicines
Capital
6,407 Million Yen
Fiscal Year End
January 31st
Number of Employees
65 (as of January 2023, consolidated)
Trade Banks
Mizuho Bank, Roppongi Branch
Sumitomo Mitsui Banking Corporation, Hibiya Branch
MUFG Bank
Resona Bank, Shimbashi Branch

History

2001
2001
  • Feb. Company Profile
2002
  • Nov. SanBio, Inc. acquired intellectual rights on the core technology from Yokohama TLO. Co., Ltd.
2009
  • Oct. Agreement with Teijin Ltd. on exclusive marketing rights in Japan for SB623 as a stroke therapy
2010
  • May. United States Food and Drug Administration (FDA) clearance for the IND (Investigational New Drug) application of SB623 as a cell therapy for patients with chronic neurological deficits
  • Sep. Option agreement with Dainippon Sumitomo Pharma Co., Ltd. on SB623 for deficits due to stroke in the U.S. and Canada
2011
  • Jan. Phase 1/2a clinical trial of SB623 for patients with chronic deficits due to stroke initiated in the U.S.
2013
  • Feb. Japanese subsidiary, SanBio Co., Ltd., established
  • May. FDA clearance for IND application of SB623 as a treatment for traumatic brain injury deficits under its preexisting IND
  • Aug. Completion of the administration of SB623 to patients with chronic deficits due to stroke in the Phase 1/2a clinical trial in the U.S.
  • Aug. Relocation of main office of SanBio Co., Ltd., to Kaigan, Minato-ku, Tokyo
2014
  • Jan. Organizational restructuring by the reversal of U.S. parent-Japanese subsidiary (Japanese subsidiary is now the parent company)
  • Feb. Presentation of data from the Phase 1/2a clinical trial of SB623 in patients with chronic deficits due to stroke at the International Stroke Conference 2014 (San Diego, U.S.) (by Dr. Gary Steinberg, Chairman, Department of Neurosurgery, Stanford University, the principal investigator for this trial)
  • Jun. FDA End of Phase 2 meeting review of the Phase 1/2a study and subsequent clearance to start a Phase 2b trial on SB623 for patients with chronic deficits due to stroke
  • Sep. Joint development and license agreement with Dainippon Sumitomo Pharma Co., Ltd. on SB623 for chronic stroke in the U.S. and Canada
  • Dec. Relocation of main office of SanBio Co., Ltd., to Akashi-cho, Chuo-ku, Tokyo
2015
  • Apr. Listing on Mothers, Tokyo Stock Exchange (Ticker symbol: 4592)
  • Jul. Start of full-scale development of SB623 for the treatment of chronic motor deficits secondary to traumatic brain injury in Japan
  • Oct. Initiation of Phase 2 clinical trial of SB623 for patients with chronic motor deficits due to traumatic brain injury in the U.S.
  • Dec. Initiation of Phase 2b clinical trial of SB623 for patients with chronic motor deficits due to stroke in the U.S.
2016
  • Mar. First two subjects randomized in Phase 2b clinical trial of SB623 for patients with chronic motor deficits due to stroke in the U.S./div>
  • Apr. Japan Pharmaceuticals and Medical Devices Agency (PMDA) clearance to start a Phase 2 Global trial on SB623 for patients with chronic motor deficits due to traumatic brain injury
  • Jul. First subject randomized in Phase 2 clinical trial of SB623 for patients with chronic motor deficits due to traumatic brain injury in the U.S.
  • Oct. First subject randomized in Phase 2 clinical trial of SB623 for patients with chronic motor deficits due to traumatic brain injury in Japan
2017
  • Jun. Received a $20 million grant from the California Institute of Regenerative Medicine (CIRM) in support of Phase 2b clinical trial for the treatment of chronic motor deficits due to stroke
  • Dec. Completion of the administration of SB623 to patients with chronic deficits due to stroke in the Phase 2b clinical trial in the U.S.
2018
  • Feb. Termination of licensing agreement with Teijin Ltd. on exclusive marketing rights in Japan for SB623 as a stroke therapy
  • Apr. Completion of the administration of SB623 to patients with chronic motor deficits due to traumatic brain injury in the Phase 2 clinical trial in both the U.S. and Japan
2019
  • Apr. SB623 awarded Sakigake Designation from the Ministry of Health, Labour and Welfare as a regenerative medicine product

    SB623 designated an advanced therapy medicinal product (ATMP) by the European Medicines Agency (EMA)
  • Jul. Obtained a license to manufacture and market regenerative medicine products in Japan
  • Sep. SB623 (for chronic motor deficit due to traumatic brain injury) granted regenerative medicine advanced therapy (RMAT) designation by the US Food and Drug Administration (FDA)
  • Dec. Terminated joint development and license agreement with Sumitomo Dainippon Pharma Co., Ltd. regarding SB623 (for chronic motor deficit due to ischemic stroke) in the US and Canada
2020
  • Mar. Entered into a business alliance with Ocumension (Hong Kong) Limited for R&D and commercialization of regenerative medicines in ophthalmology in Greater China
  • Jun. SB623 granted orphan regenerative medicine designation by the Minister of Health, Labour and Welfare, for its efficacy in ameliorating chronic effects of traumatic brain injury
2021
  • Feb. Established SanBio Asia Pte. Ltd., the group’s first subsidiary in Asia outside Japan, in Singapore
2022
  • Mar. Completed an application filing with Japan’s Ministry of Health, Labour, and Welfare for manufacture and marketing approval as a regenerative medicine product, as a treatment for chronic motor deficit from traumatic brain injury
  • Apr. Transitioned to the Growth Market, Tokyo Stock Exchange
  • Dec. Obtained a license to manufacture regenerative medicine products (Packaging, Labeling, Storage) in Japan

Office

SanBio Company Limited

St. Luke Tower 13F, 8-1 Akashi-cho, Chuo-ku, Tokyo, 104-0044
Tel: +81-(3)-6264-3481

SanBio Inc.

231 S. Whisman Road,
Mountain View, CA 94041-1522 USA

+1-650-625-8965 tel
+1-650-625-8969 fax

SanBio Asia Pte. Ltd.

105 Cecil Street #07-03
Singapore 069534

CEO Message Mission&Vision Regenerative
Medicine Business
Environment Leadership Company Profile