Enhancing and Strengthening a Product Portfolio with Distinctive Features and Competitive Advantages

「Revenue increased, driven by Iselty, an internally discovered treatment for uterine fibroids newly launched in March 2026, as well as growth in Beova, a treatment for overactive bladder; Korsuva, a treatment for pruritus in dialysis patients; and Tavalis, a treatment for persistent and chronic immune thrombocytopenia.」

「During the consolidated fiscal year, we advanced 3 internally discovered products to the clinical development stage.」

「As part of its R&D activities in the pharmaceutical business, in July 2025 the Company entered into an agreement with Viridian Therapeutics, Inc. (U.S.) to acquire exclusive development and commercialization rights in Japan for Veligrotug (generic name) and VRDN-003 (development code), treatments for thyroid eye disease. Following the commencement of domestic Phase I clinical trials of olutasidenib (generic name), a treatment for acute myeloid leukemia, in July 2025, the Company also commenced domestic Phase I clinical trials of KSP-0914 (development code), a Company-originated treatment for Graves’ disease, in August of the same year, continuing to advance its R&D projects through the development stages.」

「For linzagolix, our internally discovered product (generic name; development code: KLH-2109), we filed a marketing application in Japan for uterine fibroids in February 2025 and began a domestic Phase III clinical trial in March 2025 aimed at obtaining an additional indication for endometriosis.」

「Linzagolix, a treatment for uterine fibroids and endometriosis discovered by us (generic name; development code: KLH-2109), met the primary endpoints in 2 domestic Phase III clinical trials for uterine fibroids, and we began preparations for filing a marketing application.」

「We launched Tabaliss Tablets, a treatment for chronic idiopathic thrombocytopenic purpura, in April 2023, and KORSUVA IV Injection for Dialysis Syringe, a treatment for pruritus in dialysis patients, in December of the same year.」

「In December 2023, we launched KORSUVA IV Injection for Dialysis Syringe, a treatment for pruritus in dialysis patients that we co-developed with 丸石製薬株式会社.」

「Lovotirelin (generic name; development code: KPS-0373), a treatment for spinocerebellar degeneration, had its marketing approval application temporarily withdrawn in July of this year, and the Company is considering the feasibility of conducting additional clinical trials.」

「As part of its R&D activities in the pharmaceutical business, the Company obtained marketing approval in September of this year for difelikefalin (generic name; development code: MR13A9), a treatment for pruritus in dialysis patients for which 丸石製薬株式会社, its co-development partner, submitted an application for marketing approval in September last year. The Company is preparing to launch it after inclusion in the National Health Insurance drug price list under the product name Korsuva Injection Syringes for Dialysis 17.5 μg, 25.0 μg and 35.0 μg.」

「Regarding the spinal and cerebellar degeneration treatment rovatirelin (generic name; development code: KPS-0373), we temporarily withdrew the application for approval in July this year and are considering the feasibility of conducting additional clinical trials.」

「Following the acquisition of manufacturing and marketing approval in December last year for fostamatinib (generic name; development code: R788), we are conducting medical information activities under the product name Tavalisse Tablets 100 mg/150 mg, led by the Rare Disease Project, which specializes in marketing in the rare disease area, in preparation for its launch after inclusion in the National Health Insurance drug price list.」

「In addition, we launched in May this year the ulcerative colitis treatment Karogra Tablets, co-developed with EA Pharma Co., Ltd., and in June this year the treatment for microscopic polyangiitis and granulomatosis with polyangiitis Tabneos Capsules.」

「In addition, we launched in May this year the ulcerative colitis treatment Karogra Tablets, co-developed with EA Pharma Co., Ltd., and in June this year the treatment for microscopic polyangiitis and granulomatosis with polyangiitis Tabneos Capsules.」

「For the ulcerative colitis treatment Karogra Tablets 120 mg, co-developed with EA Pharma Co., Ltd., which obtained manufacturing and marketing approval in March this year, and the treatment for microscopic polyangiitis and granulomatosis with polyangiitis Tabneos Capsules 10 mg, for which we obtained manufacturing and marketing approval last September, the products were launched as new products in May and June this year, respectively.」

「Tabneos Capsules 10 mg, a treatment for microscopic polyangiitis and granulomatosis with polyangiitis for which manufacturing and marketing approval was obtained last September, is now the subject of medical information activities led by the Rare Disease Project, which specializes in marketing in the rare disease area, in preparation for its launch after inclusion in the National Health Insurance drug price list.」

「Regarding R&D activities in the pharmaceutical business, the Company obtained marketing approval in September of this year for avacopan (generic name; development code: CCX168), a treatment for microscopic polyangiitis and granulomatosis with polyangiitis licensed in from Vifor Fresenius Medical Care Renal Pharma Ltd. (Switzerland), for which it submitted an application for marketing approval in February of this year. The Company is preparing to launch it under the product name Tavneos Capsules 10 mg after its inclusion in the National Health Insurance drug price list. In addition, in May of this year, EAファーマ株式会社 submitted an application for marketing approval for carotegrast methyl (generic name; development code: AJM300), a treatment for ulcerative colitis that it is co-developing with the Company.」

「In June this year, following Sanwa Kagaku Kenkyusho Co., Ltd.’s acquisition of approval in the same month for the secondary hyperparathyroidism treatment Upasita Intravenous Injection Dialysis Syringe, we entered into a co-promotion agreement with the company in Japan and the 2 companies have begun medical information activities.」

「CCX168, a treatment for microscopic polyangiitis and granulomatosis with polyangiitis (development code; generic name: avacopan), which was licensed in from Vifor Fresenius Medical Care Renal Pharma Ltd. (Switzerland), has completed Phase III clinical trials, and preparations for submission of a marketing approval application are under way.」

「We initiated a domestic Phase III clinical trial for MR13A9 (development code; generic name: difelikefalin), a treatment for pruritus in dialysis patients co-developed with 丸石製薬株式会社.」

「Revenue from the pharmaceutical business was ¥14,700 million, up 4.1% year on year. Although medical information activities were limited due to the impact of COVID-19, revenue increased due to higher sales of products including the overactive bladder treatment Beova Tablets, the renal anemia treatment Darbepoetin Alfa BS Injection JCR, and the hyperphosphatemia treatments Pitol Chewable Tablets and Pitol Granules in Sachets, as well as contributions from Minirin Melt OD Tablets 25 µg/50 µg, a treatment for nocturia caused by nocturnal polyuria in men, Minirin Melt OD Tablets 60 µg/120 µg/240 µg and desmopressin products, treatments for enuresis and central diabetes insipidus, and the diabetes treatment Marizev Tablets, whose sales were transferred in April this year.」

「In line with this policy, we launched 10 products over the past 3 years in key areas including urology, nephrology and dialysis, and diabetes. We also established an R&D pipeline capable of supporting plans to launch 6 products over the next 5 years, including 4 products in rare diseases.」

「For Minirin Melt OD Tablets 25 µg and OD Tablets 50 µg, a treatment for nocturia caused by nocturnal polyuria in men, for which we entered into a co-promotion agreement in Japan with Ferring Pharmaceuticals Co., Ltd., we have been conducting medical information activities since September last year. In addition, we launched in November last year the renal anemia treatment Darbepoetin Alfa BS Injection JCR, co-developed with JCR Pharmaceuticals Co., Ltd.」

「JR-131, a biosimilar of darbepoetin alfa (generic name), a treatment for renal anemia, was submitted for marketing approval by JCRファーマ株式会社, the Company’s co-development partner, in September last year. Following the grant of marketing approval in September of this year, the Company is preparing to launch it under the product name Darbepoetin Alfa BS Injection JCR after its inclusion in the National Health Insurance drug price list. In addition, the Company entered into an agreement with Rigel Pharmaceuticals, Inc. (U.S.) to acquire exclusive development and commercialization rights in Japan, China, South Korea and Taiwan for R788, a treatment for chronic primary immune thrombocytopenia (development code; generic name: fostamatinib), and has now commenced domestic Phase III clinical trials.」

「Sales increased for the hyperphosphatemia treatments Pitol Chewable Tablets and Pitol Granules in Sachets, the overactive bladder treatment Beova Tablets, the diabetes treatment Glubes Combination Tablets and the newly launched Glubes Combination OD Tablets, an additional formulation launched in June this year, partly as a result of active medical information activities for key products.」

「In September last year, JCR Pharmaceuticals Co., Ltd., our co-development partner, filed an application for approval of JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (development code). In October last year, we entered into an agreement with Rigel Pharmaceuticals, Inc. (United States) to acquire exclusive development and marketing rights in Japan, China, South Korea and Taiwan for R788 (development code; generic name: fostamatinib), a small-molecule tyrosine kinase inhibitor. In addition, we obtained manufacturing and marketing approval in February this year for an additional formulation of the diabetes treatment Glubes Combination Tablets, an orally disintegrating tablet, and plan to launch it after its inclusion in the National Health Insurance drug price list.」

「In addition, we launched in November last year the overactive bladder treatment Beova Tablets, co-developed with KYORIN Pharmaceutical Co.,Ltd., and Pitol Granules in Sachets, an additional formulation of the hyperphosphatemia treatment developed by us.」

「Regarding R&D activities in the pharmaceutical business, manufacturing and marketing approval was obtained in September this year for KRP-114V (development code; generic name: vibegron), a treatment for overactive bladder for which our co-development partner KYORIN Pharmaceutical Co.,Ltd. filed an application for approval last September, and for the additional formulation of Pitol chewable tablets, granules, for which we filed an application for approval last September. We are preparing to launch these 2 products after their inclusion in the National Health Insurance drug price list, with KRP-114V marketed under the product name Beova Tablets and the additional formulation of Pitol chewable tablets marketed under the product name Pitol Granules in Sachets. Also in September this year, our co-development partner JCR Pharmaceuticals Co., Ltd. filed an application for approval of JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (development code). In addition, following the completion of additional studies, we ref filed an application for approval of the additional formulation of the diabetes treatment Glubes Combination Tablets, an orally disintegrating tablet, which had been temporarily withdrawn in June last year.」

「The Phase III clinical trial for JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name) co-developed with JCR Pharmaceuticals Co., Ltd., has been completed, and preparations are under way for an application for approval.」

「In the Phase III clinical trial for JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name) co-developed with JCR Pharmaceuticals Co., Ltd., equivalence to the reference biologic was verified.」

「In addition, we launched in December last year the ulcerative colitis treatment Rectable 2 mg rectal foam, 14 doses, which was co-developed with EA Pharma Co., Ltd.」

「In R&D activities in the pharmaceutical business, we filed an application for approval in September this year for an additional formulation of Pitol chewable tablets, granules. In addition, because we obtained manufacturing and marketing approval in September this year for AJG511 (development code; generic name: budesonide), a treatment for ulcerative colitis for which our co-development partner EA Pharma Co., Ltd. filed an application for approval last October, we are preparing to launch the product under the name Rectable 2 mg rectal foam, 14 doses, after its inclusion in the National Health Insurance drug price list. Also in September this year, our co-development partner KYORIN Pharmaceutical Co.,Ltd. filed an application for approval of KRP-114V (development code; generic name: vibegron), a treatment for overactive bladder. In June this year, we entered into an agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. (Switzerland) to acquire exclusive development and marketing rights in Japan for CCX168 (development code; generic name: avacopan), a complement C5a receptor inhibitor, and have initiated a Phase I clinical trial.」

「Regarding the additional formulation of Glubes, an orally disintegrating tablet for which an application for approval was filed last July, we temporarily withdrew the application in June this year in connection with the conduct of additional studies.」

「We will expand the product portfolio supporting future growth through R&D projects and active in-licensing.」

「In October last year, EA Pharma Co., Ltd., our co-development partner for AJG511 (development code; generic name: budesonide), a treatment for ulcerative colitis, filed an application for approval.」

「In July this year, we filed for approval of an additional formulation of Glubes, an orally disintegrating tablet. We also initiated a Phase III clinical trial for JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code).」

「In addition, we launched the diabetes treatment drug GlufastⓇ OD Tablets as a new product in June this year.」

「In the R&D areas of marketing and new business areas, together with biologics, we will increase R&D and in-licensing activities to enhance and strengthen the product portfolio.」