To contribute to healthy and fulfilling lives for people around the world, improve quality of life, and create a prosperous future, Seikagaku Corporation engages in the manufacturing and research and development of pharmaceuticals. Ever since its founding, Seikagaku has focused on the importance of glycoscience, creating created innovative pharmaceuticals and medical devices as a pioneer in this emerging field. 
 

In the fiscal year ended March 31, 2025, Seikagaku achieved two significant advancements in our drug development pipelines. 　
 

The first advancement was receipt of a complete response letter (CRL) concerning SI-6603, a treatment for lumbar disc herniation. Since acceptance of the Biologics License Application (BLA) by the U.S. Food and Drug Administration in May 2024, we have been responding to the FDA approval review. Although broad support for approval was received at an Advisory Committee Meeting, an FDA examination process, additional observations made, mainly concerning the manufacturing facility and control of the drug substance and drug product, and the review did not result in approval of SI-6603. Going forward, we will respond to the CRL observations as Seikagaku’s highest priority matter in preparation for resubmission at an early date. 
 

The second important advancement was the initiation of Phase III clinical studies for Gel-One, a treatment for osteoarthritis, in Japan. Gel-One is already available in overseas markets, and a single injection is expected to provide long-term pain relief. By seeking indication of Gel-One for treatment of osteoarthritis of the knee and hip, we expect to be able to provide a new treatment method to patients in Japan.
 

I request the continued understanding and support of our shareholders and other stakeholders in the coming years.

June 2025
 Ken Mizutani
 President & CEO