Announced details
Improvement of motor paralysis in the chronic phase associated with traumatic brain injury; future expansion of indications to cerebral infarction and other conditions
Change from baseline in FMMS at Week 24, the primary endpoint: 8.3±10.6 in 46 patients in the SB623 group and 2.3±4.7 in 15 patients in the sham-surgery group, p=0.0401
Date of marketing authorization: 31 July 2024; within the seven-year marketing authorization period stipulated as an approval condition
NHI drug price: ¥72,716,528
The document refers to a previous disclosure stating that the consolidated earnings forecast for the fiscal year ending January 2027 had been revised, but does not specify the financial impact.
The company does not address Contract Value.
International joint Phase II clinical trial TBI-01 (United States, Japan and Ukraine)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Akugo® Intracerebral Implant Injection (generic name: vandefitemcel) |
| Offering price | NHI drug price: ¥72,716,528 |
| Launch date | Initial shipments are expected between August 2026 and January 2027 (scheduled). |
| Applicable area | Improvement of motor paralysis in the chronic phase associated with traumatic brain injury; future expansion of indications to cerebral infarction and other conditions |
| Registration number and expiry date | Date of marketing authorization: 31 July 2024; within the seven-year marketing authorization period stipulated as an approval condition |
| Quantitative Effects | Change from baseline in FMMS at Week 24, the primary endpoint: 8.3±10.6 in 46 patients in the SB623 group and 2.3±4.7 in 15 patients in the sham-surgery group, p=0.0401 |
| Impact on Business Performance | The document refers to a previous disclosure stating that the consolidated earnings forecast for the fiscal year ending January 2027 had been revised, but does not specify the financial impact. |
| Source | International joint Phase II clinical trial TBI-01 (United States, Japan and Ukraine) |
Items this document does not state (10)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The final drug price and eligibility for public health insurance coverage were officially confirmed by the Official Gazette notice dated 20 May 2026. As medical institutions require a certain period to complete formulary adoption procedures and other preparations before initial shipments, shipments are expected in the second half of the period.