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
