Astellas Pharma Inc (Astellas) concentrates on discovering, developing, manufacturing, and commercializing medicines across gene therapy, urology, nephrology, immunology, oncology and others. The company participates in the Rx (prescription drug) business, with 18 R&D programs presently in progress. In addition, Astellas grows its Rx+ business, which includes diagnostic, preventive, therapeutic, and prognostic care. The company maintains R&D and manufacturing sites in Japan, the US, Europe, and Asia. In FY2026, the company has more than 174.4 million patients in 103 countries all over the world.

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Astellas advanced R&D as a core growth driver to accelerate performance from FY2029 onward. The company continued to prioritize moving multiple programs to clinical Proof of Concept (PoC) by FY2025 and, during the 2026 business plan period, positioned itself to initiate more than 10 Phase III/pivotal studies, with more than five expected to start by FY2027. Alongside internal development, Astellas pursued “value-added business development” to enhance the late-stage pipeline and expand future commercial impact, targeting pipeline sales potential of roughly JPY3,000,000 million by the mid-2030s. R&D activities span discovery through optimization and development, leveraging advanced modalities such as cell and gene therapy to address disease drivers and unmet medical needs. Key strategic focus areas include genetic regulation, immuno-oncology, blindness and regeneration, and targeted protein degradation, supported by active partnering in oncology, rare diseases, and immuno-sciences. The pipeline includes late-stage and emerging assets across major therapeutic areas. Notable programs include a Nectin-4–targeting antibody-drug conjugate (ADC) for muscle-invasive bladder cancer, gilteritinib for acute myeloid leukemia, and zolbetuximab for gastric cancer. Additional development includes enfortumab vedotin in bladder cancer, fezolinetant for vasomotor symptoms, and gene therapies such as resamirigene bilparvovec (X-linked myotubular myopathy) and zocaglusagene nuzaparvovec (Pompe disease). In FY2026, the company’s R&D expenditure stood at JPY314,827 million, which, as a percentage of revenue, stood at 14.7% and declined 3.9% YoY.