Nippon Shinyaku Co Ltd (Nippon Shinyaku) manufactures and commercializes pharmaceuticals and functional foods. The company's primary business includes the development of new drugs for various diseases such as urological diseases, hematological diseases, intractable or rare diseases, and gynecological diseases.

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Nippon Shinyaku is focused on distinctive drug development in small molecule drugs, nucleic acid drugs, and gene therapy. The company actively collaborates with academia and other companies to integrate useful technologies with its own, aiming to create new value. The R&D initiatives are centered around four specialty areas: hematology, intractable/rare diseases, urology, and gynecology. The company emphasizes ethical considerations in R&D, ensuring compliance with human rights and animal welfare standards. The R&D units of Nippon Shinyaku include the Discovery Research Laboratories in Kyoto and Tsukuba, which are responsible for exploring new pharmaceutical leads and conducting advanced drug discovery research. The Clinical Development Division oversees clinical trials to assess the safety and efficacy of candidate drugs. The Odawara Central Factory is involved in the development and manufacturing of formulations and active pharmaceutical ingredients for clinical trials. The company is investigating its Phase III clinical candidates: NS-065/NCNP-01 (viltolarsen) for the treatment of Duchenne muscular dystrophy. Nippon Shinyaku is evaluating its Phase II candidates: NS-304 (selexipag) for the treatment of arteriosclerosis obliterans, pediatric pulmonary arterial hypertension and lumbar spinal stenosis; and NS-580 for the treatment of endometriosis. It is also investigating NS-917 in Phase I clinical trials for relapsed/refractory acute myeloid leukemia; NS-401 (tagraxofusp) in Phase I/II for the treatment of blastic plasmacytoid dendritic cell neoplasm; and Phase II trials of NS-229 for the treatment of inflammatory diseases. In FY2026, the company spent JPY36,713 million, which, as a percentage of revenue, stood at 21.4% and grew 6.9% YoY.