SanBio Company Limited [4592.T]
TOKYO, May 20 (Pulse News Wire) – Sanbio Company Limited (4592.T) announced today that its brain implant therapy drug, Acougo (generic name: Bandefitumel), has been officially listed in the drug price standards effective immediately. The listing follows approval by the Central Social Insurance Medical Council on May 13, 2026.
Acougo is indicated for improving chronic motor paralysis associated with traumatic brain injury. It involves transplanting human mesenchymal stem cells derived from bone marrow into damaged areas of the brain through a specialized injection device. Each treatment uses 5 × 10^6 cells suspended in 300 μL of solution, administered via three pathways at intervals of 5 to 6 mm deep within the brain tissue. Clinical trials conducted in multiple international sites showed significant improvement in patients treated with Acougo compared to those receiving placebo surgery.
The primary endpoint analysis demonstrated a mean difference of 8.3 ± 10.6 points versus 2.3 ± 4.7 points for the placebo group, indicating statistical significance (p < 0.05). SanBio plans to gradually introduce Acougo into medical institutions beginning in the second half of 2026, pending necessary regulatory procedures. The company also intends to conduct post-marketing clinical studies and safety assessments over the next seven years to ensure continued approval. Additionally, SanBio aims to expand Acougo's application globally, targeting conditions such as stroke, based on the newly established pricing structure.
Discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) for domestic stroke applications are scheduled, while preparations for Phase 3 trials in collaboration with the FDA continue.
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