SanBio’s quarter to April 30 looked, at first glance, like biotech purgatory: no revenue, a ¥953 million operating loss and an ¥836 million net loss. But the more important development sits just outside the reporting window. In May, the company said AKUGO, its regenerative medicine product for chronic traumatic brain injury, was added to Japan’s reimbursement list at ¥72 million and commercial sales began. SanBio also said it had reached agreement with the US Food and Drug Administration on the design of a Phase 3 trial for traumatic brain injury, and that it plans consultations with Japan’s PMDA on cerebral infarction studies.
| Stage | Timing | What SanBio said |
|---|---|---|
| Conditional approval in Japan | July 2024 | AKUGO won conditional and time-limited manufacturing and marketing approval. |
| Approval change on shipment restriction | December 2025 | SanBio said a partial change approval was granted in connection with lifting the shipment-restriction condition. |
| Reimbursement listing | May 2026 | AKUGO was listed on Japan’s reimbursement price list at ¥72 million. |
| Commercial start | May 2026 | Sales commenced in Japan. |
| US next step | Current status | SanBio said it reached agreement with FDA on the design of a Phase 3 trial for traumatic brain injury and is preparing to start the trial. |
| Japan expansion step | Next step | SanBio said it plans PMDA consultations for cerebral infarction studies and is preparing for trial start. |
That timing explains why the top line is still blank without making the quarter irrelevant. The reported period ran from February through April, so it closed before the May reimbursement listing and sales start. SanBio kept unchanged its forecast for ¥396 million in revenue and a net loss of ¥5,133 million for the year ending January 2027.
The costs, meanwhile, are still unmistakably clinical-stage. Research and development spending was ¥680 million in the quarter, mainly tied to the approval change related to AKUGO’s manufacturing and marketing authorization. Cash and deposits fell by ¥1,085 million from the end of January. Losses narrowed from a year earlier, but not because launch revenue had already shown up in the quarter. Reported earnings were helped by a ¥177 million foreign-exchange gain, which SanBio separately said arose mainly from foreign-currency loans and related receivables involving consolidated subsidiaries. The same disclosure also described a ¥55 million deferred tax adjustment linked to those positions.
What matters now is execution. A reimbursement price of ¥72 million gives AKUGO a clear commercial unit on paper, and clearing reimbursement and shipment-related regulatory steps is a real milestone for a Japanese regenerative-medicine launch. But SanBio did not disclose early sales volume, hospital adoption or patient uptake in the cited materials. The US milestone is also an agreement on trial design, not the start of Phase 3 itself. For now, SanBio has moved from proving it can get AKUGO to market to proving it can sell it, and expand the platform beyond Japan.