Sustainable Growth as a Drug Discovery-Focused R&D Company
First written in FY2016. 23 of 38 entries say "Advanced", first in FY2020-Q1. Latest entry: 2026-07-31.
The whole theme swung hardest in 2019: 1 of 10 companies on the "Worse" side.
9 other companies' latest entry also says "Advanced".
- 2026-07-31AdvancedFinancial results presentation
「In May 2026, for olutasidenib (generic name), which we in-licensed from Rigel Pharmaceuticals (US), we submitted an application in Japan for marketing authorisation for the indication of relapsed or refractory acute myeloid leukaemia with an IDH1 gene mutation, and granted Orient EuroPharma (Taiwan) development and sales rights in Taiwan.」
Olutasidenib advanced from the application-preparation stage to submission in Japan, and the granting of development and sales rights in Taiwan was also disclosed. - FY2026AdvancedAnnual report
「Olutasidenib (generic name), a treatment for acute myeloid leukemia licensed in from Rigel Pharmaceuticals, Inc., is currently being prepared for submission of a marketing approval application. In addition, the late Phase II domestic clinical trial of Matsupexole (generic name; development code: KDT-3594), a Company-originated treatment for Parkinson’s disease, was unblinded in March 2026 and achieved its primary endpoint. Following the commencement of domestic Phase I clinical trials of KSP-0914 (development code), a treatment for Graves’ disease, in August 2025, the Company commenced domestic Phase I clinical trials of KSP-0576 (development code), a treatment for overactive bladder/interstitial cystitis and bladder pain syndrome, in February 2026, and domestic Phase I clinical trials of KSP-0930 (development code), a treatment for narcolepsy, in March 2026. During the current consolidated fiscal year, the Company advanced 3 originated products to the clinical development stage.」
Matsupexole achieved its primary endpoint in a domestic late Phase II trial, and Phase I trials were initiated for KSP-0576 and KSP-0930. Oltacidenib is being prepared for regulatory submission, and multiple R&D projects have advanced to the next stage. - FY2026-H1AdvancedAnnual report
「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.」
The R&D projects and externally licensed products made concrete progress through the acquisition of exclusive domestic rights for Veligrotug and VRDN-003 and the commencement of domestic Phase I clinical trials of olutasidenib and KSP-0914. - FY2025AdvancedAnnual report
「The Company-originated product linzagolix (generic name; development code: KLH-2109) was submitted for marketing approval in Japan for uterine fibroids in February 2025, and domestic Phase III clinical trials were commenced in March 2025 toward obtaining an additional indication for endometriosis. In addition, domestic additional Phase III clinical trials of lovotirelin (generic name; development code: KPS-0373), a treatment for spinocerebellar degeneration, commenced in March 2025.」
The R&D projects made concrete progress through the domestic marketing approval application for linzagolix, the commencement of trials for an additional indication, and the commencement of additional Phase III trials of lovotirelin. - FY2025-H1AdvancedAnnual report
「As part of its R&D activities in the pharmaceutical business, the Company-originated product linzagolix (generic name; development code: KLH-2109) achieved its primary endpoints in 2 domestic Phase III clinical trials for uterine fibroids and began preparations for submission of a marketing approval application. In September 2024, the Company also entered into an agreement with Rigel Pharmaceuticals, Inc. (U.S.) to acquire exclusive development and commercialization rights in Japan, South Korea and Taiwan for olutasidenib (generic name), a treatment for acute myeloid leukemia.」
Linzagolix progressed from achieving the primary endpoints in domestic Phase III clinical trials to the marketing approval application preparation stage, and the Company also acquired exclusive development and commercialization rights for olutasidenib in Japan, South Korea and Taiwan. - FY2024RestatedAnnual report
「The Group’s core pharmaceutical business has adopted the management vision of “aiming to become a drug discovery and research-driven company that develops and provides innovative pharmaceuticals capable of contributing to the health of people around the world.” From the perspective of “for the patients,” it is actively pursuing pharmaceutical research and development, the manufacture of high-quality pharmaceuticals, medical information activities to promote appropriate use, efficient operations and the establishment of a total marketing structure.」
The Company has reaffirmed its basic policy of growing as a drug discovery and research-driven company through research and development, manufacturing, information provision and marketing. - FY2024-Q2SoftenedAnnual report
「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.」
KPS-0373 has moved from the marketing approval application stage to consideration of the feasibility of additional clinical trials following withdrawal of the application. - FY2024-Q2AdvancedAnnual report
「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.」
MR13A9 has obtained marketing approval and progressed to the launch preparation stage pending inclusion in the National Health Insurance drug price list. - FY2024-Q1Withdrawal of marketing approval application and consideration of additional trialsAnnual report
「Regarding R&D, the Company continues to advance R&D for each project and seeks to progress projects through the development stages. In addition, in July of this year it temporarily withdrew the marketing approval application for lovotirelin (generic name; development code: KPS-0373), a treatment for spinocerebellar degeneration, and is considering the feasibility of conducting additional clinical trials.」
While setting out its policy of advancing each R&D project, the Company has moved KPS-0373 to the stage of considering the feasibility of additional clinical trials following the temporary withdrawal of its marketing approval application. - FY2023-Q3AdvancedAnnual report
「丸石製薬株式会社 submitted an application for marketing approval in September last year for difelikefalin (generic name; development code: MR13A9), a treatment for pruritus in dialysis patients that it is co-developing with the Company. In addition, the Company obtained marketing approval in December last year for fostamatinib (generic name; development code: R788), a treatment for chronic primary immune thrombocytopenia licensed in from Rigel Pharmaceuticals, Inc., for which it submitted an application for marketing approval in April last year. Toward its launch after inclusion in the National Health Insurance drug price list, the Company is 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 rare disease areas.」
MR13A9 has progressed to the marketing approval application stage, while R788 has obtained marketing approval and progressed to the launch preparation and medical information activity stages. - FY2023-Q2AdvancedAnnual report
「Regarding R&D in the pharmaceutical business, the Company submitted an application for marketing approval in April of this year for fostamatinib (generic name; development code: R788), a treatment for chronic primary immune thrombocytopenia licensed in from Rigel Pharmaceuticals, Inc. In September of this year, 丸石製薬株式会社 submitted an application for marketing approval for difelikefalin (generic name; development code: MR13A9), a treatment for pruritus in dialysis patients that it is co-developing with the Company. The Company also commenced domestic Phase III clinical trials of its originated product linzagolix (generic name; development code: KLH-2109), a treatment for uterine fibroids and endometriosis, for uterine fibroids as the indication.」
In addition to the marketing approval application for R788, the disclosure reports the marketing approval application for MR13A9 and the commencement of domestic Phase III clinical trials of linzagolix, indicating concrete progress in the R&D pipeline. - FY2023-Q1AdvancedAnnual report
「Regarding R&D in the pharmaceutical business, the Company submitted an application for marketing approval in April of this year for fostamatinib (generic name; development code: R788), a treatment for chronic primary immune thrombocytopenia licensed in from Rigel Pharmaceuticals, Inc. It also commenced domestic Phase III clinical trials of linzagolix (generic name; development code: KLH-2109), a Company-originated treatment for uterine fibroids and endometriosis, for uterine fibroids as the indication.」
R788 has progressed to the marketing approval application stage, while linzagolix has progressed to the commencement stage of domestic Phase III clinical trials for uterine fibroids as the indication. - FY2022AdvancedAnnual report
「The Company submitted an application for marketing approval in December last year for lovotirelin (generic name; development code: KPS-0373), a treatment for spinocerebellar degeneration licensed in from Shionogi & Co.,Ltd., and in April of this year submitted an application for marketing approval for fostamatinib (generic name; development code: R788), a treatment for chronic primary immune thrombocytopenia licensed in from Rigel Pharmaceuticals, Inc. In addition, difelikefalin (generic name; development code: MR13A9), a treatment for pruritus in dialysis patients co-developed with 丸石製薬株式会社, achieved its primary endpoint in domestic Phase III clinical trials.」
As a drug discovery and research-driven company, the Company reported concrete progress through the submission of marketing approval applications for KPS-0373 and R788 and achievement of the primary endpoint in the Phase III clinical trial of MR13A9. - FY2022-Q3AdvancedAnnual report
「The Company submitted an application for marketing approval in December last year for lovotirelin (generic name; development code: KPS-0373), a treatment for spinocerebellar degeneration licensed in from Shionogi & Co.,Ltd.」
KPS-0373 has progressed from the stage of detailed review of trial results and consultation with the regulatory authorities to the marketing approval application stage. - FY2022-Q2AdvancedAnnual report
「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.」
CCX168 has progressed to the launch preparation stage following the grant of marketing approval, while AJM300 has also progressed to the marketing approval application stage. The disclosure reports multiple concrete advances as a drug discovery and research-driven company. - FY2022-Q1AdvancedAnnual report
「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.」
EAファーマ株式会社 submitted an application for marketing approval for the co-developed product AJM300, marking concrete progress in drug discovery and research and development. - FY2021-Q3AdvancedAnnual report
「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.」
CCX168 has completed its Phase III clinical trial and progressed to the preparation stage for submission of a marketing approval application. - FY2021-Q2AdvancedAnnual report
「Regarding R&D activities in the pharmaceutical business, the Company has commenced domestic Phase III clinical trials of MR13A9, a treatment for pruritus in dialysis patients (development code; generic name: difelikefalin), which it is co-developing with 丸石製薬株式会社. It also continues to advance R&D for each project and seeks to progress projects through the development stages.」
In addition to continuing its R&D projects, MR13A9 has progressed to the commencement stage of domestic Phase III clinical trials. - FY2021-Q1RestatedAnnual report
「Regarding R&D in the pharmaceutical business, the Company continues to advance R&D for each project and seeks to progress projects through the development stages. In addition, the Phase III clinical trial of KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lovotirelin), has been completed. The Company is conducting detailed analyses of the results obtained in the trials, including subgroup analyses by severity, while continuing consultations with the regulatory authorities.」
The Company continues to advance each R&D project, while continuing subgroup analyses and consultations with the regulatory authorities for KPS-0373 following its Phase III clinical trial. - FY2020-Q3AdvancedAnnual report
「The Phase III clinical trial of KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lovotirelin), has been completed. The Company is conducting detailed analyses of the results obtained in the trials, including subgroup analyses by severity, while consulting with the regulatory authorities. The results of these pooled analyses (post hoc analyses) have recently been published in a medical journal.」
KPS-0373 has progressed to the stage of detailed analysis and consultation with the regulatory authorities following completion of its Phase III clinical trial, and publication of the pooled analysis results has also been reported. - FY2020-Q2AdvancedAnnual report
「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.」
JR-131 has progressed to the launch preparation stage following the grant of marketing approval, while R788 has progressed to the commencement stage of domestic Phase III clinical trials. - FY2020-Q1AdvancedAnnual report
「JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code), 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. The review process toward approval is under way.」
The Company states that JR-131 has progressed to the review stage following submission of its marketing approval application. - FY2019RestatedAnnual report
「The Group’s core pharmaceutical business has adopted the management vision of “aiming to become a drug discovery and research-driven company that develops and provides innovative pharmaceuticals capable of contributing to the health of people around the world.” From the perspective of “for the patients,” it is actively pursuing pharmaceutical research and development, the manufacture of high-quality pharmaceuticals, medical information activities to promote appropriate use, efficient operations and the establishment of a total marketing structure.」
The Company has reaffirmed its direction of pursuing sustainable growth as a drug discovery and research-driven company through the research and development, manufacture and provision of information on innovative pharmaceuticals. - FY2019-Q3RestatedAnnual report
「Regarding R&D activities in the pharmaceutical business, in September last year JCRファーマ株式会社, the Company’s co-development partner for JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code), submitted an application for marketing approval.」
The Company’s direction as a drug discovery and research-driven company continues through applications for marketing approval of R&D products and other activities. - FY2019-Q2RestatedAnnual report
「Following inclusion in the National Health Insurance drug price list, preparations are under way to launch the two drugs: KRP-114V under the product name Beova Tablets, and the additional dosage form for Pitol Chewable Tablets under the product name Pitol Granules in Sachets. In addition, in September of this year, JCRファーマ株式会社, the Company’s co-development partner for JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code), submitted an application for marketing approval.」
Applications for marketing approval of R&D products and preparations for their launch are continuing, reaffirming the Company’s direction as a drug discovery and research-driven company. - FY2019-Q1RestatedAnnual report
「The Company continues to advance R&D for each development project and seeks to progress projects through the development stages.」
The policy of continuing R&D for each development project and progressing projects through the development stages has been reaffirmed. - FY2018RestatedAnnual report
「The Group’s core pharmaceutical business has adopted the management vision of “aiming to become a drug discovery and research-driven company that develops and provides innovative pharmaceuticals capable of contributing to the health of people around the world.” From the perspective of “for the patients,” it is actively pursuing pharmaceutical research and development, the manufacture of high-quality pharmaceuticals, medical information activities to promote appropriate use, efficient operations and the establishment of a total marketing structure.」
The Company has reaffirmed its direction as a drug discovery and research-driven company focused on developing and providing innovative pharmaceuticals. - FY2018-Q1RestatedAnnual report
「The Company continues to advance R&D for each project and seeks to progress projects through the development stages.」
The Company continues to advance each R&D project and progress projects through the development stages. - FY2017RestatedAnnual report
「The Group’s core pharmaceutical business has adopted the management vision of “aiming to become a drug discovery and research-driven company that develops and provides innovative pharmaceuticals capable of contributing to the health of people around the world.” From the perspective of “for the patients,” it is actively pursuing pharmaceutical research and development, the manufacture of high-quality pharmaceuticals, medical information activities to promote appropriate use, efficient operations and the establishment of a total marketing structure.」
The policy of sustainable growth as a drug discovery and research-driven company through the development and provision of innovative pharmaceuticals has been reaffirmed. - FY2017-Q3RestatedAnnual report
「The Company has commenced Phase III clinical trials of JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code), and additional Phase III clinical trials of KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lovotirelin).」
The Company has reaffirmed that it is continuing Phase III clinical trials of JR-131 and KPS-0373 toward the creation of new drugs. - FY2017-Q2RestatedAnnual report
「The Company also continues to advance R&D for each project and seeks to progress projects through the development stages.」
The policy of continuing each R&D project and advancing projects through the development stages has been reaffirmed. - FY2017-Q1RestatedAnnual report
「With respect to research and development, the Company continues to advance R&D for each project and seeks to progress projects through the development stages.」
The policy of continuing each R&D project and advancing projects through the development stages has been reaffirmed. - FY2016First statedAnnual report
「By continuously creating new drugs, the Company is building a product portfolio that gives rise to its raison d’être and corporate value, and is promoting initiatives aimed at sustainable growth as a drug discovery and research-driven company.」
The Company has identified the creation of new drugs through research and development and the construction of a product portfolio as the basic direction for sustainable growth.