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 focuses on distinctive drug development in small molecule drugs and nucleic acid drugs, as well as gene therapy. The company actively collaborates with academia and other companies to introduce useful technologies and create new value. The company's Discovery Research Laboratories in Kyoto and Tsukuba jointly explore new pharmaceutical leads. The Clinical Development division oversees clinical trials to assess the safety and efficacy of candidate drugs in human participants. The company also has a manufacturing research facility, the Odawara Central Factory, which develops formulations and manufactures drugs. The Licensing and Alliance division is responsible for out-licensing of the company’s original drugs and improving the development pipeline through in-licensing of products and compounds that are under development. The company maintains a venture-like organizational structure and aims for distinctive drug development in small molecule drugs, nucleic acid drugs, and gene therapy as a new modality. Nippon Shinyaku introduces useful technologies through active collaboration with academia and other companies, integrating them with its technologies to create new value. The company is committed to creating new value by adding new modalities and technologies to its drug discovery foundation, which has produced NS-304 (a low molecular drug) and NS-065/NCNP-01 (a nucleic acid drug), thereby expanding the spectrum of drug discovery. Nippon Shinyaku continues active R&D investment, constantly strengthening its R&D pipeline along the three pillars of in-house drug discovery, in-licensing, and product life cycle management (PLCM). 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; Phase II trials of NS-229 for the treatment of inflammatory diseases. In FY2025, the company spent JPY34,341 million, which as a percentage of revenue stood at 21.4% and grew 8.4% YoY.