SanBio

SanBio is a Japanese regenerative medicine company engaged in the development, manufacturing and sale of cell therapy products. Its main development candidate, SB623, targets central nervous system disorders including chronic traumatic brain injury and chronic cerebral infarction. The company was founded in February 2001 in California as SanBio, Inc., and the Japanese entity SanBio Company Limited was established in February 2013; it listed on the Tokyo Stock Exchange Mothers market in April 2015 under securities code 4592. Its mission is to provide value to patients and other stakeholders through the development of regenerative medicine, with a vision of becoming a global leader in the regenerative medicine field.

SanBio, Inc. was established in California, United States, in February 2001. In November 2002, the company received an assignment of intellectual property related to the basic seed technology that became the foundation of its current development products from Yokohama TLO Company, Limited. In October 2009, it concluded an exclusive license agreement for SB623 in Japan for cerebral infarction with Teijin Limited. In May 2010, it obtained an IND from the U.S. FDA for SB623 for cerebral infarction, and in September 2010 concluded an option agreement with Dainippon Sumitomo Pharma Co., Ltd. for cerebral infarction in the United States and Canada. In January 2011, it began a Phase 1/2a clinical trial in the United States for chronic cerebral infarction. In February 2013, the Japanese entity SanBio Company Limited was established, and in May 2013 it obtained FDA IND approval for SB623 for traumatic brain injury. In August 2013, patient dosing in the U.S. Phase 1/2a trial for cerebral infarction was completed, and the head office was relocated to Kaigan, Minato-ku, Tokyo. In January 2014, a corporate reorganization reversed the parent-subsidiary relationship between Japan and the United States, making the Japanese entity the parent company. In February 2014, results of the Phase 1/2a trial for cerebral infarction were reported at the International Stroke Conference 2014 in San Diego. In June 2014, FDA approval was obtained for completion of Phase 1/2a and conduct of Phase 2b for chronic cerebral infarction, and in September 2014 a joint development and license agreement for the United States and Canada was concluded with Dainippon Sumitomo Pharma. In December 2014, the head office was relocated to Akashicho, Chuo-ku, Tokyo. In April 2015, the company listed on the Tokyo Stock Exchange Mothers market (securities code: 4592). In July 2015, it began full-scale development of SB623 for traumatic brain injury in Japan; in October 2015 it started a U.S. Phase 2 clinical trial for traumatic brain injury; and in December 2015 it started a U.S. Phase 2b clinical trial for chronic cerebral infarction. In March 2016, the first U.S. subject was enrolled in the Phase 2b clinical trial for chronic cerebral infarction. In April 2016, a clinical trial notification for a Japan-U.S. global Phase 2 trial for traumatic brain injury was accepted by the Pharmaceuticals and Medical Devices Agency (PMDA). In July 2016, the first U.S. subject was enrolled in the Phase 2 trial for traumatic brain injury, and in October 2016 the first Japanese subject was enrolled. In June 2017, the company obtained a total of USD 20 million in grant funding from the California Institute for Regenerative Medicine (CIRM) for the Phase 2b clinical trial for cerebral infarction.

Aiming to be a global leader in the regenerative medicine field, developing allogeneic cell therapy products to reach as many patients as possible.

• SB623

  Main development candidate targeting central nervous system disorders including chronic traumatic brain injury and chronic cerebral infarction.

• アクーゴ🄬脳内移植用注

  Product launched as a new treatment option for chronic motor paralysis associated with traumatic brain injury.

1. 1サンバイオ －再生医療（細胞治療薬）sanbio.com
2. 2会社概要 | サンバイオ －再生医療（細胞治療薬）sanbio.com
3. 3SanBioについて | サンバイオ －再生医療（細胞治療薬）sanbio.com
4. 4ミッション&ビジョン | サンバイオ －再生医療（細胞治療薬）sanbio.com
5. 5SanBio (Japan)wikidata.org