SanBio Co Ltd
TSE:4592
SanBio Co Ltd
SanBio Co., Ltd. engages in the development, production and sale of regenerative cells medicines. The company is headquartered in Chuo-Ku, Tokyo-To. The company went IPO on 2015-04-08. The firm has the research and development base in the United States and conducts research, development, manufacture and sale of regenerative cell medicines in Japan. The firm aims to sell therapeutic agents for diseases with high unmet medical needs, mainly in diseases of the central nervous system. The company is involved in the manufacture, development, non-clinical studies, clinical trials of technologies introduced from research institutes such as universities. The firm has five regenerative cell drugs, including the main product candidate SB623 (nerve regenerative cells), SB618 (function-enhancing type & Mesenchymal stem cells), SB308 (muscle stem cells), MSC1 (mesenchymal stem cells), and MSC2 (mesenchymal stem cells).
SanBio Co., Ltd. engages in the development, production and sale of regenerative cells medicines. The company is headquartered in Chuo-Ku, Tokyo-To. The company went IPO on 2015-04-08. The firm has the research and development base in the United States and conducts research, development, manufacture and sale of regenerative cell medicines in Japan. The firm aims to sell therapeutic agents for diseases with high unmet medical needs, mainly in diseases of the central nervous system. The company is involved in the manufacture, development, non-clinical studies, clinical trials of technologies introduced from research institutes such as universities. The firm has five regenerative cell drugs, including the main product candidate SB623 (nerve regenerative cells), SB618 (function-enhancing type & Mesenchymal stem cells), SB308 (muscle stem cells), MSC1 (mesenchymal stem cells), and MSC2 (mesenchymal stem cells).
Financials: SanBio spent JPY 1.8 billion in the last 6 months, mainly on activities for AKUUGO approval, and holds JPY 2.7 billion in cash and cash equivalents.
Guidance Revision: Operating expense forecast was revised upward from JPY 3.5 billion to JPY 3.9 billion, due to increased manufacturing-related expenses for AKUUGO inventory.
Regulatory Progress: Submitted data for AKUUGO's partial change approval in Japan, with a decision expected between August and January.
US Phase III Milestone: Reached agreement with the FDA on Phase III clinical trial design for TBI in the United States.
Strengthened Liquidity: Secured JPY 3 billion in new commitment lines from major Japanese banks to support financial stability.
Future Outlook: Plans include launching AKUUGO for TBI in Japan, preparing for commercialization in the US, and expanding into new indications like stroke.
