Enhancing the New Drug Pipeline and Consumer Healthcare Products

「For Z-100, we are steadily advancing nonclinical studies toward clinical development for a new indication and have begun a new specified clinical research study in patients with lung cancer. We are also pursuing global expansion, including by concluding a development and commercialization agreement with Agastra-Lab s.r.l. covering Europe, the United States and Canada.」

「「Z-100」につきましては、新たな適応症での臨床開発に向けて非臨床試験を着実に推進するとともに、肺がん患者を対象とした新たな特定臨床研究を開始いたしました。」

「For Z-100, we are steadily advancing nonclinical studies toward clinical development for a new indication and preparing to support a new specified clinical research study. For ZG-802, we are proceeding smoothly with a domestic Phase II trial for underactive bladder.」

「Exclusive development and commercialization agreement for Acofide, a treatment for functional dyspepsia, in Europe, the United States and Canada In September 2024, we obtained marketing approval in Japan for Veltassa, a treatment for hyperkalemia, and are preparing for its launch.」

「Under a global development structure established in collaboration with Tillotts Pharma AG, we will steadily advance the new development themes we have initiated.」

「The Group's research and development expenses for the six months ended [the second quarter] were ¥1,746 million.」

「Under exclusive development and commercialization license agreements with Meiji Seika Pharma Co., Ltd. and FAES FARMA, S.A., Z-338 (generic name: acotiamide) was filed for functional dyspepsia in Thailand and Indonesia, respectively, and in 12 Latin American countries, with approval obtained in 5 Latin American countries, including Mexico. In Japan, a Phase III trial is being conducted in pediatric patients with functional dyspepsia. Part 1, focused mainly on pharmacokinetics and safety, has been completed, and Part 2, evaluating efficacy and safety, is under way. In addition, we began a domestic Phase II trial of ZG-802 for underactive bladder, a new theme aimed at furthering the medical contribution of our proprietary acotiamide.」

「The Group's research and development expenses for the nine months ended [the third quarter] were ¥2,487 million.」

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

「The Group's research and development expenses for the three months ended [the first quarter] were ¥755 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.」

「The Group's research and development expenses for the three months ended [the first quarter] were ¥956 million.」

「The Group's research and development expenses for the six months ended [the second quarter] were ¥2,529 million. There were no material changes in research and development activities during the six months ended [the second quarter].」

「Development of Z-206 (Asacol) in China had completed a Phase III trial for ulcerative colitis, with an application for approval filed in May 2013. The Chinese authorities completed their review, and approval was obtained in April 2020. For sales of the product in China, Tillotts Pharma AG, the development sponsor, entered into an agreement in October 2019 with the Chinese subsidiary of the major Italian pharmaceutical company Menarini Group to grant exclusive sales rights.」

「The Group's research and development expenses for the nine months ended [the third quarter] were ¥4,667 million. 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].」

「The Group's research and development expenses for the three months ended [the first quarter] were ¥1,316 million. 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, had 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. We are currently focusing on preparations to obtain approval and launch the product in other European countries. For Z-213, a treatment for iron-deficiency anemia in-licensed from Swiss company Vifor (International) AG, we filed an application for marketing authorization in March 2018 and obtained approval in March 2019. ZG-801, in-licensed from Swiss company Vifor (International) AG, entered a Phase II trial in Japan for hyperkalemia. For Z-360, which had been undergoing a Phase II trial for pancreatic cancer in Asia, including Japan, 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.」

「The Group's research and development expenses for the six months ended [the second quarter] were ¥2,883 million. There were no material changes in research and development activities during the six months ended [the second quarter].」

「Following a re-evaluation of the development plans for both Z-215, a long-acting proton pump inhibitor in-licensed from EA Pharma Co., Ltd., and TP09, a treatment for familial adenomatous polyposis jointly developed with US-based Cancer Prevention Pharmaceuticals, INC., we decided to discontinue development of both projects. Meanwhile, in March 2018, we decided to newly in-license Veltassa, a treatment for hyperkalemia, from Vifor (International) AG and are preparing for clinical trials.」

「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.」

「In research and development, with the aim of developing new drugs that contribute to the international community, we will actively advance overseas new drug development while steadily progressing multiple late-stage development programs in Japan. We will also work to further expand and strengthen our new drug pipeline, including in-licensed products.」

「Group-wide research and development expenditure for the nine-month period ended 31 December 2016 was ¥6,655 million. The following change occurred in research and development activities in the prescription pharmaceuticals business during the nine-month period ended 31 December 2016: Zentacort Capsules 3 mg was launched in November 2016 for the indication of Crohn's disease.」

「Group-wide research and development expenditure for the six-month period ended 30 September 2016 was ¥3,796 million. The following change occurred in research and development activities in the prescription pharmaceuticals business during the six-month period ended 30 September 2016: Zentacort Capsules 3 mg received marketing approval in September 2016 for the indication of Crohn's disease.」

「With the aim of developing new drugs that contribute to the international community, we will actively advance overseas new drug development, including Z-100, while steadily progressing multiple late-stage development programs in Japan. We will also work to further expand and strengthen our new drug pipeline, including in-licensed products. In addition, we will actively pursue the development of consumer healthcare products, including western herbal products.」