- Business
- Nippon Shinyaku Co., Ltd. manufactures and markets prescription pharmaceuticals and functional foods primarily in Japan, with additional commercialization rights and operations in the United States, Europe, and Asia. The company operates through two main segments, offering a broad portfolio of branded drugs for urological diseases including Zalutia and Eviprostat for benign prostatic hypertrophy, Cialis for erectile dysfunction, and Erleada for castration-resistant prostate cancer; hematological malignancies such as Vidaza for myelodysplastic syndrome, Gazyva for follicular lymphoma and chronic lymphocytic leukemia, Vyxeos for high-risk acute myeloid leukemia, and Jaypirca for relapsed or refractory mantle cell lymphoma; intractable and rare diseases encompassing Viltepso for Duchenne muscular dystrophy, Yuvanci, Uptravi, Opsumit, and Adcirca for pulmonary arterial hypertension, and Fintepla for seizures in Dravet and Lennox-Gastaut syndromes; gynecological conditions like MonoVer for iron deficiency anemia; and other therapeutic areas such as Erizas for allergic rhinitis, Onetram and Tramal for cancer and chronic pain, and Regtect for alcohol abstinence support. It also provides functional foods including health supplements, protein preparations, preservatives, and condiments targeted at consumer health markets. Founded in 1911 and headquartered in Kyoto, Japan, Nippon Shinyaku focuses on niche areas like rare diseases, neurology, and immunology, serving healthcare providers, hospitals, and patients through subsidiaries such as NS Pharma in the US. Recent strategic developments include an exclusive partnership with REGENXBIO in January 2025 to develop and commercialize RGX-121 and RGX-111 gene therapies for mucopolysaccharidosis type II (Hunter syndrome) and type I (Hurler syndrome) in the US and Asia, featuring $110 million upfront and up to $700 million in milestones; an option agreement with AB2 Bio in January 2025 for US commercialization rights to Tadekinig alfa targeting NLRC4 mutation and XIAP deficiency hyperinflammatory syndromes, with up to $686 million in potential payments; expansion of its commercialization and distribution agreement with Capricor Therapeutics in September 2024 to include Europe for deramiocel in Duchenne muscular dystrophy, adding $20 million upfront, $15 million equity investment, and up to $715 million in milestones; a strategic alliance with Boston Children's Hospital announced in July 2025 to advance therapies for rare neurological disorders; launch of pediatric Uptravi tablets in Japan in March 2025 for pulmonary arterial hypertension; and additional regulatory designations such as FDA Orphan Drug status for NS-051/NCNP-04 in Duchenne muscular dystrophy and NS-229 in eosinophilic granulomatosis with polyangiitis, alongside submission of a New Drug Application for NS-401 (Tagraxofusp) in Japan.