SanBio Company Limited

Business Details

SanBio Group develops and researches SB623 (product name: Akuugo®), an allogeneic cell therapy product processed from mesenchymal stromal cells derived from bone marrow fluid of healthy donors, as its core product, targeting central nervous system diseases with high unmet medical needs such as chronic traumatic brain injury and chronic cerebral infarction. The company obtained conditional and time-limited manufacturing and marketing approval in July 2024, obtained partial approval to lift the shipment restriction condition in December 2025, and achieved listing on the National Health Insurance (NHI) drug price list at ¥72 million with sales commencement in May 2026. The company is proceeding in parallel with domestic direct sales and the promotion of U.S. clinical trials.

Recent Overview

Akuugo® was listed on the NHI drug price list at ¥72 million and sales commenced in May 2026; 1Q loss improved significantly year-on-year

In the first quarter of FY2027 (ending January 2027) (February to April 2026), the company recorded R&D expenses of ¥680 million, primarily due to costs related to obtaining partial approval for changes to matters concerning the manufacturing and marketing approval of Akuugo®, resulting in an operating loss of ¥953 million (compared to ¥1,007 million in the same period of the prior year). Due to the recording of foreign exchange gains of ¥177 million, the ordinary loss improved significantly to ¥779 million (compared to ¥1,750 million in the same period of the prior year). In May 2026, Akuugo® was listed on the NHI drug price list at ¥72 million and sales commenced. In the United States, the company reached agreement with the FDA on the Phase 3 trial design, and discussions with the PMDA are planned for domestic cerebral infarction. There is no change to the full-year earnings forecast (business revenue of ¥396 million, operating loss of ¥5,229 million).

Key Products

Growth Drivers

• Generation of the first domestic product sales revenue through the listing of Akuugo® on the NHI drug price list at ¥72 million and commencement of sales in May 2026
• Full-scale operation of manufacturing, logistics, and sales systems following the approval to lift the shipment restriction condition obtained in December 2025
• Establishment of a foundation for the restart of U.S. operations through agreement with the U.S. FDA on the Phase 3 trial design
• Indication expansion through planned discussions with the PMDA and advancement of preparations for clinical trial initiation in the domestic cerebral infarction program
• Diversity of the pipeline for indication expansion of SB623 to chronic cerebral infarction, retinal diseases, and other areas
• A funding base for R&D and commercialization activities supported by cash on hand of ¥13,997 million (end of FY2027 (ending January 2027) 1Q)

Risks

• The research and development phase with zero business revenue continues, with a substantial loss forecast for the full-year FY2027 (ending January 2027) operating loss of ¥5,229 million
• As sales of Akuugo® have only just commenced, uncertainty remains regarding the pace of adoption, as completion of in-hospital procedures at administering institutions is a prerequisite for initial shipment
• Because the approval is conditional and time-limited, post-marketing clinical trials must be conducted and full approval obtained within the 7-year manufacturing and marketing approval period
• Conducting and completing the U.S. Phase 3 clinical trial requires substantial funding and a long period of time, making continuous fundraising essential
• Foreign exchange fluctuation risk (the company recorded a foreign exchange gain of ¥177 million in the current 1Q, whereas it recorded a foreign exchange loss of ¥712 million in the same period of the prior year, indicating significant volatility)
• Cash and deposits are decreasing by approximately ¥1,000 million each quarter, making cash burn management a challenge until business revenue becomes substantial