SanBio Company Limited
4592・Growth Market・Pharmaceuticals
Business
SanBio Co., Ltd. is a regenerative medicine specialist company that conducts research, development, manufacturing, and sales of cell therapy drugs at two locations: Japan (Tokyo) and the United States (California), under its mission of "delivering value to stakeholders, including patients, through the development of regenerative medicine." Its flagship product SB623 (Akuugo®) is the world's first treatment for chronic traumatic brain injury, made by processing and cryopreserving allogeneic mesenchymal stromal cells derived from the bone marrow fluid of healthy donors; it obtained conditional and time-limited manufacturing and marketing approval in Japan in July 2024. The company broadly targets central nervous system disorders with high unmet medical needs, including chronic cerebral infarction, cerebral hemorrhage, retinal diseases, spinal cord injury, Parkinson's disease, and Alzheimer's disease. Listed on the TSE Growth Market.
Business Model
There are six types of revenue: ① upfront payments, ② milestone income, ③ development cooperation fees, ④ royalty income, ⑤ product supply income, and ⑥ product sales income (direct sales). During the development stage, mainly ①–③ are recorded, while after product launch, ④ and ⑤ are recorded under the license-out model and ⑥ under the direct-sales model. For Akuugo®, the company has chosen the direct-sales model, and with the NHI price listing and launch scheduled for May 2026, it expects to record its first product sales income (⑥). By retaining ownership of the product supply rights itself, the company also maintains a structure that secures supply income from any licensees.
Company Strengths
SB623 (Akuugo®) obtained conditional and time-limited manufacturing and marketing approval in Japan in July 2024, and in December 2025 also received a partial approval change to lift the shipment restriction condition. It is recognized by regulatory authorities as the world's first therapeutic drug for motor paralysis due to chronic traumatic brain injury, and has received the triple designation of Sakigake Designation, Orphan Regenerative Medical Product Designation, and FDA RMAT Designation.
The company has established its own mass-production technology capable of culturing homogeneous cells from donor bone marrow fluid in large quantities, cryopreserving, transporting, and thawing them for administration. Unlike autologous transplantation, the same product can be used to treat many patients. Furthermore, because the company retains product supply rights in-house, it has a revenue structure that allows it to earn both product supply income and royalty income from licensees, on a dual basis.
Following the overseas offering of new shares in November 2025, cash and cash equivalents increased to ¥14,815 million (up ¥11,962 million from the end of the previous fiscal year). SB623's target indications range across chronic cerebral infarction, cerebral hemorrhage, retinal diseases, spinal cord injury, Parkinson's disease, and Alzheimer's disease, among others, and the company holds a pipeline of five cell therapy drugs, including SB618, SB308, MSC1, and MSC2.
ENVALITH's Perspective
Performance Trend
Operating loss over the past five fiscal years peaked at ¥7,899 million in FY2023 and has continued to narrow, reaching ¥3,795 million in FY2026. In Q1 of FY2027 (ending January 2027), operating loss improved to ¥953 million (vs. ¥1,007 million in the same period of the prior year). R&D expenses decreased slightly to ¥681 million (vs. ¥723 million in the same period of the prior year). Ordinary loss improved substantially to ¥779 million (vs. ¥1,750 million in the same period of the prior year), but this was largely attributable to an external factor: a foreign exchange gain of ¥177 million (versus a foreign exchange loss of ¥712 million in the same period of the prior year). Operating revenue has continued to be zero, and product sales recognition following the listing of Akuugo® on the NHI drug price list (May 2026) will not begin until Q2 or later. The full-year forecast calls for operating revenue of ¥396 million and an operating loss of ¥5,229 million.
Growth Strategy
Building on the domestic launch of Akuugo®, the company aims to accelerate global expansion through a U.S. Phase 3 trial and expansion into the cerebral infarction indication
In May 2026, the company achieved listing on the National Health Insurance (NHI) drug price list (drug price ¥72 million) and commenced sales. Transition from conditional and time-limited approval to full approval is the next regulatory milestone. The forecast for full-year business revenue in the first year is limited at ¥396 million, but accumulating a domestic product track record will form the foundation for full approval and global expansion.
The company has reached agreement with the FDA on the Phase 3 trial design and is proceeding with preparations to initiate the clinical trial. U.S. approval acquisition also considers utilizing the RMAT (Regenerative Medicine Advanced Therapy) designation system for expedited approval, aiming to enter the world's largest market. Trial initiation, completion, and approval acquisition will require substantial time and cost.
The company plans to hold discussions with the PMDA and is advancing preparations toward trial initiation. It aims to expand indications based on the technology and regulatory track record established with chronic-phase TBI. The cerebral infarction patient population is larger than that of TBI, and market size expansion is expected upon approval acquisition.
The company positions the expansion of SB623 into indications such as chronic cerebral infarction and retinal disease, as well as global expansion into regions beyond the United States, as medium- to long-term growth opportunities. Revenue generation through licensing-out or partnerships is also maintained as an option.
Last updated: July 17, 2026