TOKYO, May 16, 2025 - (JCN Newswire via SeaPRwire.com) - Eisai Co., Ltd. announced today that it has received notification from Japan’s Ministry of Health, Labour, and Welfare (MHLW) that the “all-case surveillance” post-marketing observational study condition required at the time of approval of anticancer agent “Remitoro® for Intravenous Drip Infusion 300μg” (Denileukin Diftitox (Genetical Recombination)) for the indications of T-cell Lymphoma has been cleared.In March 2021, the MHLW approved “Remitoro” with the indications of “relapsed or refractory PeripheralT- cell Lymphoma (PTCL)” and “relapsed or refractory Cutaneous T-cell Lymphoma (CTCL)” , in Japan, with the following condition: “Because of the very limited number of subjects included in the Japanese clinical trials, the applicant is required to conduct a post-marketing observational study in all patients untildata from a certain number of patients is accumulated after its launch in the market, in order to identify thebackground information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product.”Based on the safety data in 111 patients and efficacy data in 85 patients submitted to the MHLW as the results of analyses of this all-case surveillance, the MHLW has concluded that the all-case surveillancewas conducted properly and the necessary measures to ensure proper use of the product weresufficient to lift the condition.Eisai will continually strive to promote the proper use of “Remitoro” and provide information about the product, thereby making further contributions to increase the benefits to patients and their families.About Remitoro for Intravenous Drip Infusion 300μg (Denileukin Diftitox (Genetical Recombination))This agent is a fusion protein consisting of interleukin-2 (IL-2) and partial sequence of diphtheria toxin. The antitumor effect of denileukin diftitox is believed to depend on specific binding to the IL-2 receptor on the surface of tumoral lymphocytes followed by intracellular delivery and release of diphtheria toxin fragment which inhibits proteinsynthesis and induce cell death.Eisai retains exclusive development and marketing rights for the agent in Japan and Asia.About Peripheral T-cell Lymphoma (PTCL)PTCL is a type of T-cell non-Hodgkin's lymphoma that is classified as an intermediate-grade lymphoma. PTCL isoften detected in advanced stages, and has symptoms such as swelling and lumps in the lymph nodes, fever, heavy night sweats, and weight loss. Among PTCLs, Anaplastic Lymphoma Kinase (ALK)-positive anaplastic largecell lymphoma, which occurs in the 20s and 30s, has a favorable prognosis and is curable. However, other types ofPTCL often occur around the age of 60, and may have a poor prognosis or be difficult to treat. Therefore, PTCL is still a disease with extremely high-unmet medical need. It is estimated that the number of patients with PTCL in Japan is less than 7,000.1About Cutaneous T-cell Lymphoma (CTCL)CTCL is a type of non-Hodgkin's lymphoma of primary cutaneous disease with various other manifestations in additional sites like lymph nodes and peripheral blood. In CTCL, some of the T cells (a type of lymphocyte involvedin the immune system) become cancerous, causing skin lesions and reducing the patient's QOL (Quality of Life) due to pain and pruritus. CTCL is generally a low-grade lymphoma, with initial patch and plaque skin lesions, but itprogresses slowly and advances to the tumor stage over several years to over a dozen years. CTCL is still a diseasewith extremely high unmet medical need because it has a high malignancy when it reaches the tumor stage and hasa poor prognosis. It is estimated that the number of patients with CTCL in Japan is less than 4,000.1About the results of “all-case surveillance” post-marketing observational studyThe specified post-marketing observational study is conducted for the purpose of collecting and confirming sideeffect incidence by symptom, quality, efficacy and safety information in pediatric, geriatric, pregnant patients, patients with renal dysfunction, hepatic dysfunction, patients who use the drug for a long time or those patients withany limitations or conditions in drug use.This study on Remitoro was conducted by central registration method to investigate the safety and efficacy of theagent, as well as factors that may affect them, in actual drug use under the approved conditions. The registered patients started administration of the drug for treatment within the period from May 2021 through September 2022 in86 medical facilities located in Japan. In the 111-safety analytical set, the common adverse drug reactions (ADRs)(incidence 10% or higher) were aspartate aminotransferase increased (22.5%), capillary leak syndrome (21.6%), alanine aminotransferase increased (21.6%), platelet count decreased (15.3%), hepatic function abnormal (14.4%)and pyrexia (13.5%).With respect to efficacy, the overall response rate in the 85 evaluable cases (70 cases in PTCL and 15 cases inCTCL) was 15.7% in PTCL, 20.0% in CTCL, and 16.5% in overall.(1) Vital Statistics/Patient Survey in 2023 (Health Statistics Office, Director-General for Statistics, Ministry of Health, Labour and Welfare, Japan.) (available in Japanese only) Copyright 2025 JCN Newswire via SeaPRwire.com.

Toyota City, Japan, May 16, 2025 - (JCN Newswire via SeaPRwire.com) - Toyota Motor Corporation (Toyota) announced that it will be expanding its battery electric vehicle (BEV) lineup in North America as part of Toyota's multi-pathway approach toward achieving a carbon-neutral society. The new bZ Woodland will premiere at a new vehicle launch event hosted by Toyota Motor North America (TMNA), a Toyota affiliate in North America, from May 19 to 21. The new bZ Woodland is scheduled to go on sale in North America in early 2026.The bZ4X Touring, the Japanese domestic model of the bZ Woodland is scheduled to launch(1) in Japan around spring 2026.Toward Carbon NeutralityToyota is committed to product and region-centered management with the aim of making ever-better cars. In developing powertrain systems to achieve carbon neutrality, various types of mobility are being rolled out as part of Toyota's multi-pathway approach offering electrified vehicle options tailored to customer needs in each country and region around the world.The U.S. market is expected to see steady growth, primarily in BEVs, and U.S. manufacturers have a high market share in BEVs. Therefore, it is necessary to further strengthen products. To accelerate the multi-pathway approach, Toyota is introducing the new bZ Woodland along with the bZ(2) and TOYOTA C-HR as a BEV lineup to cover SUVs, a major segment of the North American market.New bZ Woodland (North American specifications)The new bZ Woodland uses lithium-ion batteries with a total power capacity of 74.7 kWh(3)(4) to ensure a cruising range of approximately 260 miles(5) (AWD model), thanks in part to the highly efficient eAxle.It comes with battery pre-conditioning(6), with a development target of rapid charging in approximately 30 minutes(7) under cold conditions by maintaining the battery at a temperature optimal for charging.It uses NACS(8) as the rapid (DC) charging standard.The AWD model adopts a high-output type front and rear eAxle. In addition, the use of an evolved control system allows greater freedom in distributing front and rear driving force, achieving excellent driving stability even in outdoor situations.The new bZ Woodland features luggage space with a generous capacity of 30 cu.ft*3.It is scheduled to launch in North America in early 2026.(1) The partially redesigned bZ4X is also scheduled to launch in Japan the second half of 2025.(2) The North American model name for the bZ4X(3) Development target (North American specifications)(4) Calculated in accordance with IEC standard 62660-1(5) Development target value when driving in EPA mode (North American specifications)(6) A function that adjusts the battery temperature before rapid charging(7) Rapid charging time (North American specifications) at -10°C(8) NACS North American Charging SystemMoving forward, Toyota will continue to address customer needs in each region and contribute to carbon neutrality by developing various options―including HEVs, PHEVs, and FCEVs―while striving to make ever-better cars.A special Japanese website will be released today for the launch of the model for the Japanese market, with information updated as it becomes available. Copyright 2025 JCN Newswire via SeaPRwire.com.

TOKYO, May 16, 2025 - (JCN Newswire via SeaPRwire.com) - Mitsubishi Heavy Industries, Ltd. (MHI) has established a new strategic and business base in Dallas, Texas for its data center business, with the aim of reinforcing collaborations with leading companies and advanced technology firms in the United States.MHI's data center business, one of the Company's future growth areas, provides one-stop solutions that integrate power, cooling, and digital solutions utilizing its advanced technologies developed over decades backed by its extensive infrastructure business experience.The new Dallas business base, as a division of Mitsubishi Heavy Industries America, Inc. (MHIA), will accelerate MHI's next-generation product development which will be introduced to the US market, the world's largest, and to the global market. In addition, the continued expansion of Concentric, LLC, the critical power business that MHI acquired in 2023, will allow us to strengthen the provision of engineering, sales and services for data centers."In October 2021, MHI Group initiated 'MISSION NET ZERO,' targeting Net Zero CO2 emissions from its entire value chain by 2040. With the rapid expansion of digital services and AI, the demand for advanced data centers and efficient cooling systems for powerful GPU chips is increasing significantly. MHI is addressing this need with an innovative one-stop solution that integrates power, cooling, and digital technologies, transforming data centers into more sustainable and environmentally friendly infrastructure.We invite you to join us in this endeavor to create a brighter and greener future for our planet," states Shin Gomi, Senior General Manager of Global Data Center & Energy Management.Through these initiatives, MHI aims to enhance the decarbonization and energy efficiency of data centers, which are significant energy consumers. MHI is committed to delivering a comprehensive one-stop solution that effectively integrates power supply, cooling, and digital technologies, fostering the decarbonization of data centers from both energy supply and efficiency perspectives. We welcome your collaboration in this crucial mission for a sustainable future.About MHI GroupMitsubishi Heavy Industries (MHI) Group is one of the world’s leading industrial groups, spanning energy, smart infrastructure, industrial machinery, aerospace and defense. MHI Group combines cutting-edge technology with deep experience to deliver innovative, integrated solutions that help to realize a carbon neutral world, improve the quality of life and ensure a safer world. For more information, please visit www.mhi.com or follow our insights and stories on spectra.mhi.com. Copyright 2025 JCN Newswire via SeaPRwire.com.