Notice of receipt of partial approval changes for addition of a manufacturing site to ensure stable supply of Stavaronin®

Background and purpose

StellaPharma is strengthening its stable supply framework for the BNCT therapeutic Stavaronin®, expanding its long-term manufacturing and supply base. This release announces receipt of a partial approval change to add a new domestic contract manufacturing site as a manufacturing facility. As part of a plan to transfer from a major contract manufacturer undergoing quasi-bankruptcy, the company is proceeding with pilot-plant prototype manufacturing, quality assessments, and manufacturing trials and process validation at a commercial plant to rebuild a stable supply framework.

Outlook and business impact

After approval, commercial manufacturing can be conducted at the new site, improving supply stability and capacity to meet future demand growth. Reviews will be conducted by PMDA and GMP conformity inspections, with an anticipated approval timing around January 2027. The BNCT business growth strategy includes expanding indications and overseas expansion, and this filing is positioned as an important initiative contributing to expanded treatment opportunities and enhanced corporate value.