Progress in Clinical Trials and Regulatory Filings for Multiple Products

「For our proprietary product Z-338 (generic name: acotiamide hydrochloride hydrate) for functional dyspepsia, the licensee FAES FARMA,S.A. obtained approval in 2 additional countries, Nicaragua and Costa Rica. … In Japan, enrollment in the Phase III trial in pediatric patients has ended, and we are proceeding with preparations to compile the trial results.」

「国内におきましては、小児患者を対象としたフェーズⅢ試験は被験者募集が終了し、試験結果のまとめに向けて対応を進めております。」

「For ZG-802, we completed the domestic Phase II trial and will consider the next stage of development, including overseas expansion.」

「In September 2024, we obtained Japanese manufacturing and marketing approval for the hyperkalemia treatment Veltassa and are preparing for its launch. Agreement for the exclusive development and marketing of the functional dyspepsia treatment Acofide in Europe, the United States and Canada」

「For our proprietary product Z-338 (generic name: acotiamide), under the licensing agreement with FAES FARMA,S.A., we obtained approval in 2 additional countries, El Salvador and Peru, for functional dyspepsia, and began sales in Mexico in October 2023. In addition, under the licensing agreement with Meiji Seika ファルマ株式会社, we obtained approval in Thailand for functional dyspepsia. Our Vietnamese subsidiary, Pharmaceutical Joint Stock Company of February 3rd (hereinafter, “F.T.Pharma”), filed a marketing authorization application in Vietnam for functional dyspepsia. In addition, United Italian Trading Corporation newly filed a marketing authorization application in Singapore for functional dyspepsia.」

「ZG-801, in-licensed from Swiss company Vifor (International) AG, completed a domestic Phase III trial for hyperkalemia, and preparations for filing an application are under way.」

「There were no material changes to the management policies, management strategies or other matters established by the Group during the third quarter of the current consolidated cumulative period.」

「The Group's research and development expenses for the six months ended [the second quarter] were ¥1,607 million.」

「However, it has become clear that Z-100 exhibits diverse pharmacological effects based on immunostimulatory activity, including an inhibitory effect on cancer. In addition, in the previous trial conducted from 2004 to 2013, a subgroup analysis limited to subjects with stage IIIB disease showed a statistically significant difference in overall survival, the primary endpoint, in favor of the Z-100 group over the placebo group. Accordingly, we intend to continue research and development of Z-100.」

「For Z-100, we had conducted a Phase III multinational clinical trial in 7 Asian countries, including Japan, for cervical cancer. Because no significant difference was observed between the Z-100 and placebo groups in overall survival, the primary endpoint, we decided to review our development policy. For ZG-801 (indication: chronic heart failure with hyperkalemia), we decided not to participate in the multinational clinical trial. This was because Vifor (International) AG, the licensor, decided to discontinue the multinational clinical trial as the enrollment of patients and accumulation of cardiovascular events had been significantly delayed by the global spread of COVID-19. For development of Z-206 (Asacol) in China, approval had been obtained in April 2020, and the Chinese subsidiary of Menarini Group, the licensee, began sales in July 2021.」

「There were no material changes to the management policies, management strategies or other matters established by the Group during the first quarter of the current consolidated cumulative period.」

「There were no material changes in research and development activities during the six months ended [the second quarter].」

「For our proprietary product Z-338 (Acofide), we are conducting a Phase III trial in Europe for functional dyspepsia. In Japan, we also began a Phase III trial in pediatric patients with functional dyspepsia.」

「There were no material changes in research and development activities during the nine months ended [the third quarter].」

「There were no material changes in research and development activities during the six months ended [the second quarter].」

「There were no material changes in research and development activities during the three months ended [the first quarter].」

「TP05, an improved high-dose mesalazine formulation using new technology, obtained approval in 15 European countries by December 2018 as ASACOL 1600 mg, a treatment for ulcerative colitis, and was launched in 4 countries, including Denmark and the Netherlands. Z-213, a treatment for iron-deficiency anemia in-licensed from Swiss company Vifor (International) AG, obtained approval in March 2019. Z-100 had completed all scheduled patient enrollment. For Z-360, we decided to discontinue development following a re-evaluation of its development plan.」

「ZG-801, in-licensed from Swiss company Vifor (International) AG, entered a Phase II trial in Japan for hyperkalemia. TP05, an improved mesalazine formulation for ulcerative colitis, was launched in some European countries in December 2018. Z-360 had been undergoing a Phase II trial for pancreatic cancer in Asia, including Japan, but following a re-evaluation of its development plan, we discontinued development of the product.」

「There were no material changes in research and development activities during the six months ended [the second quarter].」

「Z-213, a treatment for iron-deficiency anemia in-licensed from Swiss company Vifor (International) AG, completed a Phase III trial, and an application for marketing approval was filed in March 2018.」

「The contract for TP09, a treatment for familial adenomatous polyposis being developed in a Phase III trial jointly with US-based Cancer Prevention Pharmaceuticals, INC., has ended.」

「Z-215, a proton pump inhibitor licensed from EA Pharma Co., Ltd., had been undergoing Phase II trials for gastroesophageal reflux disease. However, after reconsidering the development plan, we discontinued development of the drug.」

「Z-206 (Asacol) underwent, jointly with Kyowa Hakko Kirin Co., Ltd., a Phase III trial for ulcerative colitis to add dosage and administration options, and we filed an application for approval in July 2016, obtaining approval in May 2017. TP05 completed a Phase III trial for ulcerative colitis and an application for approval was filed in Europe in January 2017.」

「Zentacort Capsules 3 mg was launched in November 2016 for Crohn's disease.」

「Zentacort Capsules 3 mg obtained marketing approval in September 2016 for Crohn's disease.」

「Z-206 (Asacol) completed, jointly with Kyowa Hakko Kirin Co., Ltd., a Phase III trial for ulcerative colitis to add dosage and administration options, and we filed an application for approval in July 2016.」

「Z-206 (Asacol) had been undergoing, jointly with Kyowa Hakko Kirin Co., Ltd., a Phase III trial for ulcerative colitis to add dosage and administration options. The trial has ended, and preparations for an application for approval are under way. Z-338 (Acofide) is undergoing a Phase III trial in Europe for functional dyspepsia. Z-100 is undergoing a Phase III multinational clinical trial in Asia, including Japan, for cervical cancer.」