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Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.
Hitachi Chemical has entered into agreements with Daiichi Sankyo and SanBio Group to manufacture regenerative medicines developed by the respective companies. On March 19, 2018, Hitachi signed an agreement with Daiichi Sankyo to conduct clinical manufacturing of that company’s regenerative medicine for the Japanese market, and on March 13, 2018, it signed an agreement with SanBio to manufacture late-stage clinical products and commercial products of SB623, a proprietary regenerative medicine being developed by SanBio.
For Daiichi Sankyo, Hitachi plans to start manufacturing the clinical product at its new facility in Yokohama City, Kanagawa Prefecture, Japan. For SanBio, Hitachi will manufacture SB623 for the United States and Japanese markets using its global facilities.
SanBio is developing and pursuing rapid commercialization in Japan and the US of SB623 as a new drug candidate for central nervous system disorders. The drug candidate is in a Phase IIb clinical trial for treating chronic motor deficit from ischemic stroke and in a Phase II global trial for treating chronic motor deficit from traumatic brain injury.
"We are delighted to have reached an agreement to work with the Hitachi Chemical Group as our long-term SB623 supply partner. They are a world leader in the fields of healthcare, high technology, consumer, and other products with a reputation for quality and reliability. Their global reach will not only enable us to serve Japan and the US but potentially other worldwide regenerative medicine markets," said Keita Mori, CEO of SanBio, in a company press release.
"We look forward to meeting the global development and manufacturing requirements for SB623, for the benefit of patients with central nervous system disorders," said Robert A. Preti, PhD, general manager of the Hitachi Chemical Regenerative Medicine Business Sector and CEO of HCATS, in the press release. "This agreement demonstrates the advantages and multinational reach of HCATS's globally harmonized PCT services platform, as it will leverage our capabilities for contract manufacturing of regenerative medicine products both in Japan (Yokohama) and the US (New Jersey and California)."
In May 2017, Hitachi Chemical wholly acquired Hitachi Chemical Advanced Therapeutics Solutions, a contract manufacturer of regenerative medicine products in the US. The company will begin operation of its process development/contracting manufacturing facility in Yokohama City with the PCT platform, the global cell therapy manufacturing and development service platform of the Hitachi Chemical Regenerative Medicine Business Sector, in April 2018. This facility will be the company’s third global base and largest-scale facility in Japan.
The PCT service platform includes contract development and manufacturing organization services at current good manufacturing practices standards, including clinical manufacturing, commercial manufacturing, and manufacturing development.
Hitachi plans to operate the contracted manufacturing business for regenerative medicine in Japan and around the world, including Europe and the US.