Under our medium-term management plan, which began in the fiscal year ending March 2023, we have been pursuing five key initiatives, including “Maximizing the product value of SI-6603 (treatment for lumbar disc herniation)” and “Accelerate R&D utilizing unique drug-discovery technologies”.

Regarding SI-6603, which received a non-approval decision from the U.S. Food and Drug Administration (FDA) in March 2025, we are diligently addressing the FDA’s feedback in preparation for resubmission. This remains our highest priority, and we aim to resubmit by March 2026.
For Gel-One, a treatment for osteoarthritis currently in Phase III clinical trials in Japan, we have entered into a joint development and sales agreement with Ono Pharmaceutical Co., Ltd. Through the combined efforts of both companies, we will steadily advance development toward early approval.
Furthermore, for SI-449, an adhesion barrier, we submitted an application for medical device manufacturing and marketing approval in Japan in August 2025. SI-449 is an adhesion barrier primarily composed of cross-linked chondroitin sulfate, developed using our proprietary glycosaminoglycan cross-linking technology. Unlike existing products, we believe its powdered form is designed to meet medical needs in laparoscopic surgery. We are currently working through the review process to obtain approval.

By advancing research and development, including SI-6603, which we expect to be our next growth driver, we are committed to contributing to the improvement of health and quality of life for patients worldwide, while striving to further enhance our corporate value.

We sincerely ask for the continued understanding and support of our shareholders and all stakeholders.

December 2025
 Ken Mizutani
 President & CEO