Stella Pharma Receives PMDA Approval for New Manufacturing Site Addition

TOKYO, Aug 07 (Pulse News Wire) – Stella Pharma Corporation (4888.T) announced today that it has received confirmation of receipt of its application to amend approval items related to adding a new manufacturing site for its boron drug agent, Steboronine® (generic name: Borofuran (10B)), used in BNCT therapy. The amendment seeks to incorporate a new domestic contract manufacturer to bolster supply stability and enhance production capacity.

This move is crucial for Stella Pharma's long-term growth strategy in BNCT, aiming to ensure stable supply and support future demand expansion. The company previously entered into a development subcontract agreement with a new domestic manufacturer in October 2025 following the quasi-bankruptcy of its primary contractor. Since then, the company has completed pilot plant trials and conducted quality evaluations, process validations, and stability tests in preparation for commercial-scale production.

Looking ahead, Stella Pharma expects to undergo regulatory review and GMP suitability inspections through the Pharmaceutical and Medical Devices Agency (PMDA). According to previous statements made on April 28, 2026, the company anticipates securing approval around January 2027. The submission aligns with the company’s strategic timeline and underscores its commitment to reinforcing supply infrastructure for Steboronine®.

Moving forward, Stella Pharma remains focused on achieving steady supply under the new manufacturing framework post-approval, positioning itself for further growth in the BNCT sector.