Kissei Pharmaceutical has filed for domestic manufacturing and marketing approval of the new drug Ordasitide for the treatment of relapsed or refractory IDH1 mutation-positive acute myeloid leukemia, aiming for new indications following approval in the United States in September 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Ltd.","jir_importance":"\u2605\u2605\u2606\u2606\u2606","jir_publication_date":"2026-05-27","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/05\/4547-20260527-01.pdf","jir_short_summary":"Kissei Pharmaceutical has filed for domestic manufacturing and marketing approval of the new drug Ordasitide for the treatment of relapsed or refractory IDH1 mutation-positive acute myeloid leukemia, aiming for new indications following approval in the United States in September 2024.","jir_summary":"### Overview of Performance\nThis document reports that Kissei Pharmaceutical has submitted an application for domestic manufacturing and marketing approval of the new drug Ordasitide for the treatment of relapsed or refractory IDH1 mutation-positive acute myeloid leukemia. Ordasitide was approved in the United States in December 2022, and an exclusive development and sales agreement was granted to Ligel Corporation for Japan, Korea, and Taiwan. This application aims to expand the indications of the drug and provide new treatment options for rare diseases.\n\n### Future Outlook and Corporate Activities\nThe direct impact of this matter on financial performance is already incorporated into the consolidated earnings forecast for the fiscal year ending March 2027. Kissei Pharmaceutical is committed to developing treatments for rare diseases and will continue to promote new drug research, development, and approval acquisition. Based on approval status domestically and internationally, the company aims to expand its business and provide new treatment options for patients.","jir_financial_highlights":"Application Submission Date: 2026-05-27 (Unknown)","jir_category":"","jir_hashtags":"#KisseiPharmaceutical, #IRRelated, #JapanStocks","jir_key_figures":"Application Submission Date: 2026-05-27\nU.S. Approval Date: 2022-12\nTarget Disease: Relapsed or refractory IDH1 mutation-positive acute myeloid leukemia","jir_meta_title":"\u3010Kissei Pharmaceutical\u3011New Drug Approval Application | May 2026","jir_meta_description":"Kissei Pharmaceutical has submitted an application for approval of an acute myeloid leukemia treatment in Japan, aiming to expand treatment options for rare diseases. Announced on May 27, 2026.","jir_og_title":"\u3010Kissei Pharmaceutical\u3011New Drug Approval Application | May 2026","jir_og_description":"Kissei Pharmaceutical announces submission of approval application for leukemia treatment. Expectations are high for future business development and patient support.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":8930,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"financial_summary","footnotes":""},"sector":[],"importance":[],"class_list":["post-54996","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n