Seikagaku engages in research and development of innovative drugs that contribute to health and fulfill the lives of people around the world.
Seikagaku Corporation considers its social mission to be to continue the creation of original and, innovative pharmaceuticals and medical devices that respond to unmet medical needs utilizing the glycoscience-related technology and expertise that we have accumulated over many years and to deliver these products to patients around the world.
Under the three-year mid-term management plan that ended in the fiscal year ended March 31, 2022 in keeping with the slogan “Innovative Thinking,” Seikagaku implemented important measures to ensure its position as a pharmaceutical company with lasting social and economic value around the world through innovative drug discovery that utilizes knowledge of glycoscience. During the period of the management plan, although our activities were affected by plan delays and other obstacles arising from the COVID-19, we were able to launch the joint function improvement agent JOYCLU in Japan and steadily advance to the late development stage two pipeline drugs: in the U.S., SI-6603, a treatment for lumbar disc herniation, and in Japan, SI-449, an adhesion barrier. Going forward, we will make the early approval and launch of these drugs a priority. In May 2022, we initiated a Phase III clinical study in the U.S. for SI-614, a treatment for dry eye. Also, to make the use of JOYCLU safer for patients, we are working to identify the cause of shock or anaphylaxis associated with its administration.
Furthermore, in addition to the progress made with these development pipelines, in the area of research, efforts to create research seeds that offer prospects for future global business expansion through the strengthening and utilization of unique GAG*-related drug discovery technologies and pursuit of an open innovation strategy have begun to produce results.
We will continue to actively engage in R&D as a science-driven professional organization with the aim of meeting unmet medical needs of patients around the world.
*GAG: Glycosaminoglycan(One of the constituents of complex carbohydrates)
In order to rapidly and continuously create new products, Seikagaku engages in efficient R&D activities by focusing on target compounds and prioritizing target diseases. The focus of our drug discovery is glycosaminoglycans (GAG), which are the structural components known as glycoconjugates.
In research spanning nearly 70 years, we have accumulated a wealth of experience and expertise related to GAG drug discovery research and GAG production and formulation technologies. Today, we apply hyaluronic acid or unmodified GAG in pharmaceuticals and also engage in research and development of modified GAG produced using a cross-linking technology as well as enzymes and other substances that act on GAG. Given the properties of GAG, we focus mainly on orthopedic disorders and ophthalmic diseases as high-priority areas for now, where we have expertise through the development of such products as ARTZ Dispo joint function improving agent and OPEGAN ophthalmic viscoelastic device.
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, GAGrelated 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 followed a drug discovery approach of increasing the bioactivity of GAG, mainly through GAG modification and processing, and we are currently applying GAG to drug delivery systems (DDSs). 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 combining Seikagaku’s DDS technologies with drugs and technologies that other companies possess, not only low-molecular compounds, but also proteins and middle molecules such as peptides and nucleic acids.
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.
Seikagaku, while its scale is small compared with major pharmaceutical companies, invests much of its management resources in new drug development by entrusting sales of its products to other companies. This is apparent in the basic policy that 25 to 30% of net sales is invested in R&D expenses each year and one third of all employees is engaged in R&D (about 45% on a non-consolidated basis). Seikagaku continues to emphasize R&D activities as a R&D-oriented pharmaceutical company.