SanBio's SB623 Therapy Reaches Market at ¥72mn, But Revenue Stays at Zero

SanBio's cell therapy for chronic traumatic brain injury, known by its development code SB623, has cleared every regulatory step needed to reach a patient's bedside, yet the company's own books show it has yet to generate a single yen of product revenue.

The therapy won conditional, time-limited manufacturing and marketing approval in July 2024. A follow-up approval in December 2025 lifted the shipping restriction that had kept it off the market, clearing the way for Japan's health authorities to add it to the national drug price list in May 2026 at ¥72mn. Sales began shortly after.

That launch has not yet shown up in SanBio's ledger. For the six months to July 31, 2026, the company again booked zero product revenue, even as spending tied largely to the approval process pushed research and development costs to ¥1.23bn.

A ¥185.8mn foreign-exchange gain helped narrow the bottom line, cutting the ordinary loss to ¥1.73bn from ¥2.48bn a year earlier, and the net loss attributable to shareholders to ¥1.79bn from ¥2.00bn, aided by the same currency swing.

Cash and equivalents fell ¥2.14bn over the half to ¥12.68bn, and net assets dropped ¥1.88bn to ¥11.72bn. To offset accumulated deficits, shareholders approved cutting both capital and capital reserves by ¥1.70bn each, a 20.29% reduction that took effect in June. SanBio still holds ¥3bn in undrawn bank credit lines, but those commitments carry covenants tied to maintaining minimum cash and net-asset levels and to the therapy's regulatory standing.

SanBio says it is now building physician outreach and supply infrastructure for the therapy at home, while pursuing a Phase 3 trial design it has agreed with the U.S. Food and Drug Administration and a planned discussion with Japan's drug regulator on expanding into stroke treatment. None of that changes the immediate arithmetic: a priced, approved product that has yet to book its first sale.