| 2001-02 |
Established SanBio, Inc. in California, USA. |
| 2002-11 |
Acquired intellectual property rights for the basic seed technology, which forms the core of the current development products, from Yokohama TLO Inc. |
| 2007 |
SB623 obtains a license for the manufacturing and sale of regenerative medicine and related products in Japan. |
| 2009 |
SB623 designated as a target item under the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation in the chronic traumatic brain injury field. |
| 2009-10 |
Entered into an exclusive implementation license agreement for SB623 in Japan for stroke with Teijin Inc. |
| 2010-05 |
Obtained IND approval from the US FDA for SB623 stroke indication. |
| 2010-09 |
Signed option agreements for SB623 stroke in the US and Canada with Dai Nippon Sumitomo Pharma Co., Ltd. |
| 2011-01 |
Initiated Phase 1/2a clinical trials in the US for SB623 chronic stroke indication. |
| 2012 |
Termination of the joint development and license agreement for SB623 in the chronic ischemic stroke indication in the United States and Canada with Sumitomo Dainippon Pharma Co., Ltd. |
| 2013-02 |
Established the Japanese subsidiary SanBio Inc. |
| 2013-05 |
Obtained IND approval from the US FDA for SB623 traumatic brain injury indication. |
| 2013-08 |
Completed dosing of patients in Phase 1/2a clinical trials for SB623 stroke in the US. Moved SanBio Inc.'s headquarters to Kaigan, Minato-ku, Tokyo. |
| 2013-08 |
Completed dosing of patients in the Phase 1/2a clinical trial for SB623 stroke in the United States. |
| 2013-08 |
Moved the headquarters of Sanbio Co., Ltd. to Kaigan, Minato-ku, Tokyo. |
| 2014-01 |
Implemented a reverse parent-child corporate restructuring (Japanese subsidiary became parent company). |
| 2014-02 |
Results of Phase 1/2a clinical trials for SB623 stroke were presented at the International Stroke Conference 2014 in San Diego, USA (presented by Professor Gary Steinberg, Chief of Neurosurgery at Stanford University, and clinical trial lead). |
| 2014-06 |
Obtained US FDA approval to conclude Phase 1/2a and commence Phase 2b for SB623 chronic stroke indication. |
| 2014-09 |
Signed joint development and licensing agreements for SB623 chronic stroke in the US and Canada with Dai Nippon Sumitomo Pharma Co., Ltd. |
| 2014-12 |
Moved SanBio Inc.'s headquarters to 8-1 Akasaka-cho, Chuo-ku, Tokyo. |
| 2015-04 |
Listed on the Tokyo Stock Exchange Mothers market (ticker: 4592). |
| 2015-07 |
Commenced full-scale development of SB623 for traumatic brain injury in Japan. |
| 2015-10 |
Initiated Phase 2 clinical trials for SB623 traumatic brain injury in the US. |
| 2015-12 |
Initiated Phase 2b clinical trials for SB623 chronic stroke in the US. |
| 2016-03 |
Enrolled the first patient in Phase 2b clinical trials for SB623 chronic stroke in the US. |
| 2016-04 |
In the field of SB623 traumatic brain injury, the PMDA accepted the clinical trial submission for a US-Japan global Phase 2 study. |
| 2016-07 |
In the Phase 2 clinical trial for SB623 traumatic brain injury, the first participant was enrolled in the United States. |
| 2016-10 |
In the Phase 2 clinical trial for SB623 traumatic brain injury, the first participant was enrolled in Japan. |
| 2017 |
Established Usonian Investments LLC in 2017 and assumed the roles of CEO and CIO. |
| 2017-06 |
Received a total grant of $20 million from the California Institute for Regenerative Medicine (CIRM) for a Phase 2b stroke clinical trial. |
| 2017-12 |
Enrollment of participants in the US for the Phase 2b clinical trial of SB623 chronic stroke has been completed. |
| 2018-02 |
Agreed to terminate the exclusive implementation license agreement with Teijin Corporation for the use of SB623 in chronic stroke in Japan. |
| 2018-04 |
Enrollment of participants in the Phase 2 clinical trial of SB623 chronic traumatic brain injury in Japan and the US has been completed. |
| 2019-04 |
SB623 was designated as a subject item under the 'Accelerated Review System' for regenerative medicine products by the Ministry of Health, Labour and Welfare. SB623 also received designation as an advanced therapy medicinal product from the European Medicines Agency (EMA). |
| 2019-04 |
SB623 designated as a target item under the 'Accelerated Review Designation System' for regenerative medicine and related products by the Ministry of Health, Labour and Welfare. |
| 2019-04 |
SB623 receives designation as an advanced therapy medicinal product from the European Medicines Agency (EMA). |
| 2019-07 |
Obtained a license for the manufacturing and sale of regenerative medicine products for SB623 domestically. |
| 2019-09 |
SB623 was designated as a target item under the FDA's Regenerative Medicine Advanced Therapy (RMAT) program in the chronic traumatic brain injury field. |
| 2019-12 |
Terminated the joint development and license agreement for SB623 in chronic stroke between Daiichi Sankyo Co., Ltd. and the US and Canada. |
| 2020-03 |
Signed a business partnership agreement with OCUMENSION (HONG KONG) LIMITED for research, development, and commercialization of regenerative cell therapies for retinal diseases in Greater China. |
| 2020-06 |
Received designation as a regenerative medicine product for rare diseases from the Minister of Health, Labour and Welfare for the benefit of improving sequelae in traumatic brain injury with SB623. |
| 2021-02 |
Established its first subsidiary in Asia, SANBIO ASIA PTE. LTD., in Singapore. |
| 2022-03 |
Completed the application for manufacturing and sales approval of regenerative medicine products with the Ministry of Health, Labour and Welfare for the benefit of improving motor function impairment after traumatic brain injury with SB623. |
| 2022-04 |
Transitioned to the Tokyo Stock Exchange Growth Market. |
| 2022-12 |
Obtained a domestic license for manufacturing of regenerative medicine products (packaging, labeling, storage). |
