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History

February 2001 SanBio, Inc. established in California, U.S.
November 2002 SanBio, Inc. acquired intellectual rights on the core technology from Yokohama TLO. Co., Ltd.
October 2009 Agreement with Teijin Ltd. on exclusive marketing rights in Japan for SB623 as a stroke therapy
May 2010 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
September 2010 Option agreement with Dainippon Sumitomo Pharma Co., Ltd. on SB623 for deficits due to stroke in the U.S. and Canada
January 2011 Phase 1/2a clinical trial of SB623 for patients with chronic deficits due to stroke initiated in the U.S.
February 2013 Japanese subsidiary, SanBio Co., Ltd., established
May 2013 FDA clearance for IND application of SB623 as a treatment for traumatic brain injury deficits under its preexisting IND
August 2013 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.
December 2013 Relocation of main office of SanBio Co., Ltd., to Kaigan, Minato-ku, Tokyo
January 2014 Organizational restructuring by the reversal of U.S. parent-Japanese subsidiary (Japanese subsidiary is now the parent company)
February 2014 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)
June 2014 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
September 2014 Joint development and license agreement with Dainippon Sumitomo Pharma Co., Ltd. on SB623 for chronic stroke in the U.S. and Canada
December 2014 Relocation of main office of SanBio Co., Ltd., to Akashi-cho, Chuo-ku, Tokyo
April 2015 Listing on Mothers, Tokyo Stock Exchange (Ticker symbol: 4592)
July 2015 Start of full-scale development of SB623 for the treatment of chronic motor deficits secondary to traumatic brain injury in Japan
October 2015 Initiation of Phase 2 clinical trial of SB623 for patients with chronic motor deficits due to traumatic brain injury in the U.S.
December 2015 Initiation of Phase 2b clinical trial of SB623 for patients with chronic motor deficits due to stroke in the U.S.
March 2016 First two subjects randomized in Phase 2b clinical trial of SB623 for patients with chronic motor deficits due to stroke in the U.S.
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