Strengthening Glycoscience Platform Technologies and the Development Pipeline

「The company filed an application for marketing approval for a medical device in August 2025 and is responding to the review process toward approval.」

「• Results showing statistically significant improvement for the primary and secondary endpoints of the domestic pivotal trial of SI-449, an adhesion-prevention material (July 2023) • Initiation in Japan of Phase III clinical trials of Gel-One for osteoarthritis of the knee and hip (February 2025)」

「In the pivotal trial in gastrointestinal surgery that has been conducted since May 2020, results obtained in July 2023 showed a statistically significant adhesion-prevention effect for both the primary endpoint, the presence or absence of postoperative adhesions, and the secondary endpoints, the severity and extent of adhesions. No significant safety issues were identified.」

「We will apply and expand our core technologies in glycoscience to create new development projects in existing areas and innovative research projects, including new disease areas, while promoting various alliances. Through these efforts, we aim to achieve the early and continuous launch of new drugs that will be key to future business growth.」

「In the primary endpoint of the Phase III clinical trial conducted since May 2022, no statistically significant improvement was observed. In response, we are analyzing the data obtained and considering our future development policy.」

「Follow-up ended in March 2023 for an additional trial in the Phase III clinical program, and in May of the same year we obtained top-line results showing a statistically significant improvement in the primary endpoint. We will now prepare for an early approval application. Follow-up for a Phase III clinical trial evaluating efficacy and safety ended in June 2023, and the data obtained are currently being analyzed.」

「Although the trial schedule had been delayed by the impact of the spread of COVID-19, subject enrollment was completed in September 2022 for the pivotal trial in gastrointestinal surgery.」

「In March 2022, subject enrollment was completed for an additional trial in the Phase III clinical program. The plan is to conduct data analysis and prepare an approval application after a 1-year follow-up period.」

「In November 2021, we began a pilot trial in the field of gynecology. The trial is being conducted to expand the range of applications by confirming operability and safety in gynecology.」

「To achieve the early and continuous launch of new drugs that will be key to future business growth, we will pursue efficient activities by narrowing the target substances and priority diseases, while expanding the number of projects by strengthening our proprietary drug-discovery technologies and leveraging open innovation.」

「To achieve the early and continuous launch of new drugs that will be key to future business growth, we will pursue efficient activities by narrowing the target substances and priority diseases, while expanding the number of projects by strengthening our proprietary drug-discovery technologies and leveraging open innovation.」

「In Japan, we obtained marketing approval on 23 March 2021 for the indications of osteoarthritis of the knee and hip under the name Joicur joint injection 30 mg, a joint-function improvement agent, and began sales in May of the same year.」

「Based on the results of 3 Phase III clinical trials conducted in Japan, we filed an application in January 2020 for domestic marketing approval for the indications of osteoarthritis of the knee, hip and ankle joints. At a meeting of the Second Subcommittee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council held in January 2021, approval for the knee and hip indications was endorsed. We will continue to take appropriate steps toward obtaining marketing approval in cooperation with our sales partner.」

「Based on the results of 3 Phase III clinical trials conducted in Japan, we filed an application in January 2020 for domestic marketing approval for the indications of osteoarthritis of the knee, hip and ankle joints. We have been responding promptly to inquiries from the regulatory authorities, and as of the end of September 2020, we had not seen any impact on the review from COVID-19 and understood that it was proceeding smoothly.」

「We are responding promptly and appropriately to inquiries from the regulatory authorities, and understand that the review is proceeding according to schedule at this time.」

「Following confirmation of favorable results in the pilot trial launched in May 2018, we began a pivotal trial in May 2020 to evaluate efficacy, safety and operability, including the prevention of postoperative adhesions.」

「Based on the results of 3 Phase III clinical trials conducted in Japan, we filed an application in January 2020 for domestic marketing approval for the indications of osteoarthritis of the knee, hip and ankle joints.」

「For SI-613, a treatment for osteoarthritis, 3 domestic Phase III clinical trials have been completed, and preparations are under way to file for approval during the current fiscal year based on their results.」

「For SI-613, a treatment for osteoarthritis, follow-up ended in June this year for the clinical trial targeting osteoarthritis in four sites other than the knee, one of the 3 Phase III clinical trials being jointly developed with 小野薬品工業株式会社 in Japan, and the program advanced to the analysis of the data obtained. In February this year, we obtained top-line results showing a statistically significant improvement in a pivotal trial for osteoarthritis of the knee, and data from a long-term administration trial are scheduled to become available in September this year. Taking the results of these 3 trials into account, we will aim to file an application for marketing approval in the first half of 2020.」

「In February 2019, we obtained top-line results from a pivotal trial for the knee joint showing a statistically significant improvement in the WOMAC score, the primary endpoint, 12 weeks after the first dose. WOMAC is an assessment measure for knee pain.」

「Our group aims to develop as a global category pharma company that focuses its R&D on glycobiology, our area of expertise, and contributes to healthy and fulfilling lives for people worldwide. To achieve the early and continuous launch of new drugs that will be key to future business growth, we are strengthening our R&D capabilities and working to expand our domestic and international glycobiology research networks.」

「Our group aims to develop as a global category pharma company that focuses its R&D on glycobiology, our area of expertise, and contributes to healthy and fulfilling lives for people worldwide. To achieve the early and continuous launch of new drugs that will be key to future business growth, we are strengthening our R&D capabilities and working to expand our domestic and international glycobiology research networks.」

「In May 2018, we began a domestic clinical pilot trial of SI-449, an anti-adhesion material used in surgical procedures.」

「We will establish core technologies and build a strong R&D organization for further growth, in order to strengthen our drug-discovery and life-cycle-management pipeline supporting the next generation of growth.」

「In September 2017, we began a late Phase II clinical trial of SI-613, a treatment for osteoarthritis, for enthesopathy of tendons and ligaments, jointly with 小野薬品工業株式会社.」

「In June 2017, we began a Phase II clinical trial of SI-613, a joint-function improvement agent, in the United States. SI-613 combines hyaluronic acid and a nonsteroidal anti-inflammatory drug (NSAID) through a chemical bond using our proprietary drug-binding technology, and is being developed in Japan and the United States.」

「For SI-613, a novel joint-function improvement agent being developed for global expansion, the company began a Phase III clinical trial in Japan in February 2017 and signed a basic agreement with Ono Pharmaceutical Co., Ltd. in May 2017 concerning joint development and a marketing partnership in Japan.」

「In Japan, we began a Phase III clinical trial of SI-613, a joint-function improvement agent, in February 2017. The trial is intended to verify the efficacy and safety of SI-613 following confirmation of clinically useful effects in a Phase II clinical trial conducted for osteoarthritis of the knee.」

「To achieve the early and continuous launch of new drugs that will be key to future business growth, we are strengthening our R&D capabilities and working to expand our domestic and international glycobiology research networks.」

「We possess core technologies that surpass those of other companies in the field of glycobiology, are accelerating exploratory research and continuously generating development programs.」