Seikagaku engages in research and development of innovative drugs that contribute to health and fulfill the lives of people around the world.

Seikagaku continues to take on the challenge of addressing unmet medical needs by fully leveraging its cutting-edge glycoscience technologies and extensive know-how cultivated over many years. We regard it as our social mission to create original and innovative pharmaceuticals and medical devices and to help open up a brighter future for patients around the world.

The medium-term management plan that commenced in the fiscal year ended March 2023 concluded in 2026. While recognizing that further challenges remain in order to achieve the targets initially set, we were able to gain a solid sense of accomplishment as a “period for realizing growth.” We believe the results achieved during this period will serve as an important foundation for Seikagaku’s future leap forward and as a valuable experience that broadens our outlook toward the next stage. Going forward, we will continue to vigorously promote initiatives aimed at the steady launch of late-stage development products and at strengthening and expanding our pipeline to achieve sustainable growth.

Regarding SI-6603 (U.S.), a treatment for lumbar disc herniation, we received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in March 2025. Although approval was not granted, the clinical risk-benefit profile of this product was discussed at an Advisory Committee meeting held in January 2025, and its approval was supported. We have been making every effort to address the manufacturing and quality control issues noted in the CRL, and in March 2026 we resubmitted the application. We will continue our efforts toward obtaining approval and launching the product as early as possible.
 

In addition, SI-449 (Japan), an adhesion barrier, was submitted for approval in August 2025 and obtained approval in April 2026. We are currently preparing for its launch. We expect that, by taking advantage of the characteristics of this novel powder formulation with excellent spreadability, it will be widely used in the fields of gastrointestinal surgery and obstetrics/gynecology. We will also advance development of this product with a view not only to the Japanese market but also to global expansion.

Furthermore, Gel-One, which is already marketed in the U.S., Italy, and Taiwan, is currently being evaluated in Japan in two Phase III clinical trials and a long-term study for the treatment of osteoarthritis of the knee and hip joints. Enrollment is progressing steadily, and we are moving forward with the aim of providing a new treatment option following ARTZ and JOYCLU.

At our research laboratories, in addition to creating new development themes in our existing fields such as orthopedic disorders and ophthalmic disorders, we are also working to enhance innovative research themes that realize integration with new modalities, leveraging our research achievements in the field of glycoscience cultivated for approximately 80 years. We are also seeing progress in new disease areas. We will continue our daily research efforts so that we can present concrete themes in the near future.

The Research & Development Division will continue working to enhance our pipeline in order to respond to the unmet needs of a greater number of patients. For Seikagaku, which derives more than 50% of its sales from overseas markets, the globalization of each division is also an important issue. By collaborating with our overseas subsidiaries and partners, we will do our utmost to deliver our products to global markets as early as possible.

Our drug discovery efforts focus on glycosaminoglycan (GAG), one of the components of glycosaminoglycans, which are complex carbohydrates with which we have long been involved. Over approximately 80 years, we have accumulated a wealth of experience and know-how in GAG drug discovery research as well as in production and formulation technologies. For example, in the field of osteoarthritis, we have brought to market ARTZ, based on hyaluronic acid itself, followed by Gel-One, a cross-linked hyaluronic acid product, and JOYCLU, in which hyaluronic acid is chemically bound to diclofenac, an anti-inflammatory analgesic. In other words, in addition to GAG itself, we will continue our efforts to create new pharmaceuticals and medical devices by combining GAG with a variety of technologies and modalities.

We will also continue to take on challenges in disease areas in which these novel GAG and GAG-related substances can be expected to demonstrate the greatest efficacy, not only in the orthopedic disorders and ophthalmic disorders in which we have traditionally focused, but also in areas such as the urological disorders, where SI-449 has been launched as an adhesion barrier and SI-722 is under development.

Seikagaku’s Management Creed states: “Under the principle of respect for learning, we contribute to human wellbeing by creating and supplying the world with safe and useful pharmaceutical products based on glycoscience.” In keeping with this creed, we have made glycoscience the core foundation of our business and explicitly adopted a stance of respect for learning. Seikagaku’s origin is closely bound up with this creed.

In 1950, Seikagaku became the first company in the world to successfully produce chondroitin sulfate, which is a sort of GAG, on a commercial scale. This breakthrough laid the foundation for our current business, which is centered on glycoscience. The manufacture of chondroitin sulfate marked the starting point for expansion of our business to bulk products, as well as reagents and diagnostics, and this has led to the strengthening of our ties to glycoscience related academia and research institutes.

Through this close relationship with academia, we acquired the idea of applying hyaluronic acid in pharmaceuticals. R&D activities spanning many years culminated in 1987 with the successful development and launch of ARTZ, the world’s first joint function improving agent whose main ingredient is hyaluronic acid. The development of HERNICORE, a treatment for lumbar disc herniation that contains condoliase, an enzyme that degrades GAG, also originated from collaboration with academia.

Seikagaku will continue to make glycoscience the central focus of R&D activities and, on the basis of research results in the field of glycoscience achieved in collaboration with universities and research institutes, strive to create pharmaceuticals and medical devices and deliver them to patients around the world. 

GAG are formed when amino sugars (sugars that include nitrogen atoms) and uronic acids (a class of sugar acids) or galactose are linked together to form chain-like structures (sugar chains). Sugar chains are known in the life sciences as the third biological chain, along with nucleic acids and proteins, but they have complex chemical structures because they are molecules that handle various kinds of information within living organisms. In research in areas such as structural analysis, automatic synthesis, and large-scale synthesis, this complexity poses characteristic difficulties not found in other biological materials.

However, long-term efforts in the industry and academia have advanced the structural analysis and synthesizing technologies of sugar chains. In addition, the genes of sugar-chain synthesizing enzymes and degrading enzymes have been comprehensively identified, and our understanding of the homeostasis of sugar chains in living organisms and their pathological function is advancing.

This progress in glycoscience technologies is closely linked with Seikagaku’s drug discovery research.

Seikagaku possesses a GAG compound library, GAG-related enzymes, and wide-ranging technologies for manipulating these substances.We actively utilize these assets, accumulated in the course of research spanning many years, in drug discovery activities.We have also developed a global network of collaborating glycoscience researchers and engage in multiple joint research projects with universities and research institutes.
 

Specifically, we continue to focus on drug discovery for orthopedic disorders and ophthalmic diseases and have also begun utilizing GAG-related technology to expand new fields. At the same time, we make efforts to maximize the value of our products on the market or themes in development through expansion of indications, additional formulations, changes in dosage and administration, etc.
 

Until now, Seikagaku has pursued a drug discovery approach aimed primarily at enhancing the bioactivity of GAG through modification and processing. In addition, we are currently working on new drug delivery systems (DDS) that utilize GAG. Going forward, we will also incorporate approaches focused on the biological functions of glycans to further expand the possibilities of drug discovery.Furthermore, going forward, we will also adopt an approach focused on the biological functions of sugar chains to open up new possibilities in drug discovery.
 

In our DDS, we are researching technologies that utilize the characteristics of modified GAG to freely control drug dose and the location and timing of release. We will pursue drug discovery and development capable of responding to a wide range of unmet medical needs by designing GAG for various modalities—not only low-molecular compounds, but also so-called middle molecules, such as peptides and nucleic acids, and high polymers, such as proteins—and providing Seikagaku’s own DDS.

While we strive to speed-up in-house development, we are also keen to introduce development themes from outside research institutes, bioventure companies and pharmaceutical companies. In addition to orthopedic disorders, we target diseases and therapies having high unmet medical needs. We periodically review in-licensing candidates, always seeking balance with the progress of other development themes. We are also working to strengthen our research network in Japan and overseas, as well as to streamline the R&D organizational structure. 

Although Seikagaku is smaller in scale than major pharmaceutical manufacturers, by entrusting the sales of its pharmaceuticals and other products to third parties, it is able to concentrate a large portion of its management resources on new drug development. This is reflected in the fact that 20% to 30% of its sales revenue is allocated to research and development expenses, and that approximately 20% of the Seikagaku Group’s consolidated employees are engaged in research and development. Going forward as a research and development-oriented pharmaceutical company, we will continue to maintain a strong commitment to R&D.