Growth of the Prescription Pharmaceutical Business Driven by Asacol, Acofide, and Entocort

「Virtasa, a treatment for hyperkalemia, became free of restrictions on the duration of medication in December 2025, and we are working to develop the market at an early stage, focusing on nephrology, dialysis and cardiovascular medicine.」

「Although affected by a drug price revision, the functional dyspepsia treatment Acofide achieved market penetration and generated sales exceeding those of the previous fiscal year.」

「Virtasa Suspension Fine Granules in 8.4g sachets, a treatment for hyperkalemia launched in Japan in March 2025, is being developed for early market penetration.」

「We actively deployed sales resources to Dificlir, substantially expanding sales, particularly in Europe. Entocort, an inflammatory bowel disease treatment, saw lower sales due to the impact of generic products launched in some overseas countries. Acotiamide was almost unchanged from the previous fiscal year. In March 2025, we began domestic sales of Virtasa Suspension Fine Granules in 8.4g sachets, a treatment for hyperkalemia, and are working toward early market penetration.」

「Our flagship ulcerative colitis treatment Asacol struggled in Japan due mainly to the impact of the drug price revision implemented in April 2024, but performed well in overseas markets, including the Nordic countries, and benefited from foreign exchange movements, resulting in higher overall sales. Dificlir substantially increased sales in France, Germany, the United Kingdom and other countries. Entocort, an inflammatory bowel disease treatment marketed in Japan as Zentacort, also increased sales, supported by strong performance in Canada and foreign exchange movements. Acotiamide, a treatment for functional dyspepsia, was almost unchanged from the previous fiscal year. In September 2024, we obtained marketing authorization in Japan for Virtasa, a treatment for hyperkalemia, and are preparing to launch it.」

「In Japan, we will continue to expand our prescription pharmaceutical and consumer healthcare businesses. Although the prescription pharmaceutical business faces a challenging operating environment, we will actively deploy sales resources to Acotiamide, our original product, as well as F inject, Dificlir and ZG-801, a treatment for hyperkalemia expected to launch in fiscal 2024, to enhance our presence in the domestic prescription pharmaceutical market.」

「Our flagship ulcerative colitis treatment Asacol struggled in Japan due mainly to the impact of the drug price revision implemented in April 2023, but performed well in overseas markets, including the United Kingdom and Germany, supported by growth in the 1600mg formulation, resulting in steady overall sales. Dificlir, a treatment for Clostridioides difficile infection, substantially increased sales in France, the United Kingdom, Spain and other countries as we continued to actively deploy sales resources overseas. In Japan, we assumed the marketing authorization from Astellas Pharma Inc. in April 2023 and are working to promote the product under the domestic brand name Dificlir. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, struggled due to the impact of generic products launched in some overseas countries. F inject continues to undergo market development, focusing on obstetrics and gynecology and gastroenterology.」

「Our flagship ulcerative colitis treatment Asacol struggled in Japan due mainly to the impact of the drug price revision implemented in April 2023, but performed well in overseas markets, including the United Kingdom, supported by growth in the 1600mg formulation, resulting in steady overall sales. Dificlir, a treatment for Clostridioides difficile infection, substantially increased sales in France, Spain, the United Kingdom and other countries as we continued to actively deploy sales resources overseas. In Japan, we also assumed the marketing authorization from Astellas Pharma Inc. in April 2023 and began sales under the domestic brand name Dificlir. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, struggled due to the impact of generic products launched in some overseas countries. F inject continues to undergo market development, focusing on obstetrics and gynecology and gastroenterology.」

「Dificlir is recommended as a first-line treatment in European infectious disease clinical guidelines, and demand is expected to expand, particularly in Europe. In Japan, we also assumed the marketing authorization for Dificlir in April 2023 and began sales, and will concentrate sales resources in Japan and overseas to drive sales growth.」

「Our flagship ulcerative colitis treatment Asacol performed well in overseas markets, supported by growth in the high-dose formulation Asacol 1600mg, and sales increased. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, also expanded sales overseas, including in Canada, the Nordic countries and Italy. Although generic products were launched in some European countries last September, their impact is currently limited. Dificlir, a treatment for Clostridioides difficile infection, substantially increased sales after we actively deployed sales resources while it was recommended as a first-line treatment in European infectious disease clinical guidelines. Acotiamide and F inject are being developed in the market, focusing on medical institutions that perform endoscopies and the gastroenterology and obstetrics and gynecology fields, respectively.」

「Our flagship ulcerative colitis treatment Asacol performed steadily in overseas markets, supported by growth in the high-dose formulation Asacol 1600mg, and sales increased. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, also expanded sales overseas, driven by growth in Canada, the Nordic countries and Italy, where a local subsidiary was established last year. Dificlir, a treatment for Clostridioides difficile infection, substantially increased sales after we actively deployed sales resources while it was recommended as a first-line treatment in European infectious disease clinical guidelines. Acotiamide and F inject are being developed in the market, focusing on medical institutions that perform endoscopies and the gastroenterology and obstetrics and gynecology fields, respectively.」

「Our flagship ulcerative colitis treatment Asacol saw sales in Japan fall below the same quarter of the previous year, mainly due to the impact of the drug price revision implemented in April 2022. However, overseas sales recovered in the Nordic countries, where they had been weak in the first quarter of the previous fiscal year, and also benefited from growth in Asacol 1600mg, resulting in strong overall sales.」

「Our flagship ulcerative colitis treatment Asacol performed well, supported by growth in the high-dose formulation Asacol 1600mg in overseas markets. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, saw lower sales after struggling in some regions, including Canada and Spain. Dificlir, a treatment for Clostridioides difficile infection whose marketing authorization and distribution rights in Europe, the Middle East and other regions were transferred from Astellas Pharma Europe Ltd. in November 2020, has already completed the transfer procedures in major European countries and is making a significant contribution to sales. F inject, launched in Japan in September 2020, is being developed in the market mainly through gastroenterology and obstetrics and gynecology.」

「Our flagship ulcerative colitis treatment Asacol continued to perform steadily, supported by growth in the high-dose formulation Asacol 1600mg in overseas markets. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, increased sales after almost overcoming the decline caused by shipping delays during last year's spread of COVID-19. Dificlir, a treatment for Clostridioides difficile infection whose marketing authorization and distribution rights in Europe, the Middle East and other regions were transferred from Astellas Pharma Europe Ltd. last November, has already completed the transfer procedures in major European countries and is making a significant contribution to sales. F inject, launched in Japan last September, is being developed in the market mainly through gastroenterology and obstetrics and gynecology.」

「For Dificlir, a treatment for Clostridioides difficile infection whose marketing authorization and distribution rights in Europe, the Middle East and other regions were transferred from Astellas Pharma Europe Ltd. in November last year, the transfer procedures in major European countries have already been completed, and the product is making a significant contribution to sales. F inject 500mg, an iron-deficiency anemia treatment launched in Japan last September, is being developed in the market mainly through gastroenterology and obstetrics and gynecology.」

「In September 2020, we launched F inject 500mg, an iron-deficiency anemia treatment, and are focusing on developing the market so that it can benefit patients as a new treatment option for iron-deficiency anemia. In November 2020, our wholly owned subsidiary Tillotts Pharma AG acquired from Astellas Pharma Europe Ltd. the marketing authorization and distribution rights for Dificlir tablets, a treatment for Clostridioides difficile infection, in Europe, the Middle East, Africa and the Commonwealth of Independent States. We will develop it into the subsidiary's next core product through synergies with existing products.」

「Our flagship ulcerative colitis treatment Asacol was affected by competing and generic products and two drug price revisions, in October 2019 and April 2020, but sales exceeded the same quarter of the previous year, partly because the sales partnership with Kyowa Kirin Co.,Ltd. ended at the end of March 2020 and we began selling the product independently from April 2020. Overseas sales also continued to expand in the United Kingdom, Nordic countries and elsewhere. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, performed steadily in some countries but struggled overall due in part to shipping delays caused by the spread of COVID-19. Acotiamide, a treatment for functional dyspepsia, continued efforts to identify potential patients, particularly through medical institutions that perform endoscopies, but struggled due to the impact of reduced medical consultations amid the spread of COVID-19. In September 2020, we launched F inject 500mg, an iron-deficiency anemia treatment.」

「Our flagship ulcerative colitis treatment Asacol saw sales in Japan fall slightly below the same quarter of the previous year following two drug price revisions, in October 2019 and April 2020. Overseas sales also expanded in the United Kingdom, Nordic countries and elsewhere, but overall sales declined slightly as this growth failed to offset the impact of the stronger Swiss franc. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, continued to perform steadily, particularly in Germany and the Nordic countries. Acotiamide, a treatment for functional dyspepsia, continues to be developed by identifying potential patients, particularly through medical institutions that perform endoscopies.」

「Our flagship ulcerative colitis treatment Asacol saw lower sales in Japan due to competing and generic products, but sales grew overseas, including in the United Kingdom and Nordic countries, helped by ASACOL 1600mg. This growth more than offset the decline in Japan, resulting in higher overall Asacol sales. Entocort, an inflammatory bowel disease treatment marketed in Japan as Zentacort, saw steady sales growth in Japan, but struggled overall due to inventory adjustments and other factors in some overseas regions. Acotiamide, a treatment for functional dyspepsia, is being advanced through efforts to identify potential patients, particularly through medical institutions that perform endoscopies.」

「Our flagship ulcerative colitis treatment Asacol struggled in Japan due to the October 2019 drug price revision and the impact of generic and competing products, but performed well overseas, helped by ASACOL 1600mg, which was launched in Europe in December 2018, resulting in continued growth in overall sales. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, struggled due to the impact of inventory adjustments in some overseas regions. Acotiamide, a treatment for functional dyspepsia, continues to be developed by identifying potential patients, particularly through medical institutions that perform endoscopies.」

「Our flagship ulcerative colitis treatment Asacol struggled in Japan due to generic and competing products, but performed well overseas, helped by ASACOL 1600mg, which was launched in Europe in December 2018, resulting in continued growth in overall sales. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, struggled due to the impact of inventory adjustments in some overseas regions. Acotiamide, a treatment for functional dyspepsia, continues to be developed by identifying potential patients, particularly through medical institutions that perform endoscopies.」

「Our flagship ulcerative colitis treatment Asacol struggled in Japan due to generic and competing products, but performed well overseas, helped by ASACOL 1600mg, which was launched in Europe in December 2018, resulting in higher overall sales. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, struggled because inventory adjustments were required in some overseas regions. Acotiamide, a treatment for functional dyspepsia, continues to be developed by identifying potential patients, particularly through medical institutions that perform endoscopies.」

「Through synergies between our flagship products Asacol and Entocort/Zentacort, we will work to enhance our presence in the IBD field in Japan and overseas. In particular, overseas, we will seek the early penetration of ASACOL 1600mg, launched in Europe in December 2018, and work to expand sales. In Japan, we will also work to establish the market at an early stage for F inject 500mg, an intravenous treatment for iron-deficiency anemia approved in March 2019, focusing on obstetrics and gynecology and gastroenterology. We will continue to increase awareness of Acotiamide, including the disease and its treatment options, among medical institutions and develop it into a core product in the prescription pharmaceutical business.」

「Our flagship ulcerative colitis treatment Asacol increased sales steadily in the United Kingdom and France, its major markets, but struggled in Japan due to the drug price revision in April last year and the impact of generic and competing products. In December 2018, sales of the high-dose formulation ASACOL 1600mg began in some European countries, with plans to expand the countries where it is launched sequentially. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, expanded sales mainly in Japan, Canada and the Nordic countries. Acotiamide, a treatment for functional dyspepsia, continues to be developed by identifying potential patients, particularly through medical institutions that perform endoscopies.」

「Our flagship ulcerative colitis treatment Asacol struggled mainly in Japan due to the April drug price revision and the impact of generic and competing products. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, expanded sales, particularly in Japan, Canada and the Nordic countries. Acotiamide, a treatment for functional dyspepsia, continues to be developed by identifying potential patients, particularly through medical institutions that perform endoscopies.」

「Our flagship ulcerative colitis treatment Asacol struggled both in Japan, due to the April drug price revision and the impact of generic and competing products, and overseas, due to lower sales in some regions and the stronger Swiss franc. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, continued to expand sales in Japan and overseas. Acotiamide, a treatment for functional dyspepsia, continues to be developed by identifying potential patients, particularly through medical institutions that perform endoscopies. In November 2017, we began co-promotion of the infliximab BS intravenous infusion 100mg product "Nichi-Iko" and are working to strengthen our product lineup in the gastroenterology field.」

「The ulcerative colitis treatment Asacol, our flagship product, obtained approval in Japan in May 2017 for once-daily dosing and we worked to strengthen its competitiveness, but it struggled due to the impact of generic and competing products. Overseas, sales expanded steadily, driven by growth in the United Kingdom and Nordic countries, securing higher overall revenue.」

「In November 2017, we also began co-promotion of the infliximab BS intravenous infusion 100mg product "Nichi-Iko" and are working to strengthen our product lineup in the gastroenterology field.」

「The ulcerative colitis treatment Asacol, our flagship product, remained firm overall as overseas operations performed steadily, despite the impact of generic products in Japan. In Japan, approval for once-daily dosing was obtained in May 2017, strengthening the product's competitiveness. Acotiamide, a treatment for functional dyspepsia, increased sales, but market development remained behind plan, and we continue to work to identify potential functional dyspepsia patients, particularly through medical institutions that perform endoscopies. Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, saw sales activities after the transfer from AstraZeneca delayed versus plan in some regions, and we are working to recover the shortfall.」

「In Japan, approval for once-daily dosing was obtained in May 2017, strengthening the product's competitiveness. Sales of Entocort, an inflammatory bowel disease (IBD) treatment marketed in Japan as Zentacort, continued to expand. Acotiamide, a treatment for functional dyspepsia, continues to face delays in market development versus plan, but we are working to advance its uptake by identifying potential functional dyspepsia patients, particularly through medical institutions that perform endoscopies.」

「Through synergies between our flagship products Asacol and Entocort/Zentacort, we will work to enhance our presence in the IBD field in Japan and overseas. In Japan, we will also make maximum use of the addition of once-daily dosing for Asacol to expand our market share in the domestic oral mesalazine market, where competition from competing and generic products is intensifying. We will increase awareness of Acotiamide, including the disease and its treatment options, among medical institutions and develop it into a core business at an early stage.」

「The ulcerative colitis treatment Asacol, our flagship product, continued to perform steadily overseas, but struggled in Japan due to the drug price revision in April last year and the impact of generic drugs. Entocort, an inflammatory bowel disease (IBD) treatment for which our wholly owned subsidiary Tillotts Pharma AG acquired worldwide rights excluding the United States from AstraZeneca, continued to perform steadily. In Japan, sales of the Crohn's disease treatment Zentacort Capsules 3mg began last November. Acotiamide, a treatment for functional dyspepsia, continues to face delays in market development versus plan, but we are working to advance its uptake by increasing awareness of the disease and treatment options among medical institutions.」

「Functional dyspepsia treatment Acotiamide continues to face delays in market development versus plan, but we are working to advance its uptake by increasing awareness of the disease and treatment options among medical institutions. In addition, Entocort, an inflammatory bowel disease (IBD) treatment for which our wholly owned subsidiary Tillotts Pharma AG acquired worldwide rights excluding the United States from AstraZeneca in July last year, continued to perform steadily and contributed to sales and profit. In Japan, marketing authorization was obtained in September this year for the Crohn's disease treatment Zentacort Capsules 3mg, and preparations for its launch are under way.」

「The ulcerative colitis treatment Asacol, our flagship product, struggled in Japan due to the April drug price revision and the impact of generic drugs, but remained firm overseas, resulting in higher overall revenue. Functional dyspepsia treatment Acotiamide continues to face delays in market development versus plan, but we are working to advance its uptake by increasing awareness of the disease and treatment options among medical institutions. Entocort, an inflammatory bowel disease (IBD) treatment for which our wholly owned subsidiary Tillotts Pharma AG acquired worldwide rights excluding the United States from AstraZeneca in July 2015, continued to perform steadily and contributed to sales and profit.」

「We will further consolidate Asacol's position as the leading brand in Japan's oral mesalazine market, work to build the market for Acafide and develop it into a core product of the business. We will also work to enhance our presence in the inflammatory bowel disease field through synergies between Entocort, for which we acquired the rights, and Asacol.」