- Business
- Nippon Shinyaku Co., Ltd. manufactures and sells pharmaceuticals and functional foods primarily in Japan, the United States, Asia, and other international markets; the company operates through Pharmaceuticals and Functional Food Business segments, with core prescription drugs targeting urology (Zalutia for urinary disorders, Eviprostat and Bladderon for prostatic hypertrophy and pollakisuria, Cialis for erectile dysfunction), hematology and oncology (Vidaza for myelodysplastic syndrome, Cylocide and CylocideN for leukemia and lymphoma, Gazyva for anti-CD20 monoclonal antibody therapy, Jaypirca for mantle cell lymphoma and chronic lymphocytic leukemia, Vyxeos for acute myeloid leukemia), rare and intractable diseases (viltolarsen and brogidirsen (NS-089/NCNP-02) for Duchenne muscular dystrophy, Uptravi for pulmonary arterial hypertension), gynecology, inflammation, allergies, cardiovascular, metabolic, and gastrointestinal disorders (Estracyt for prostate cancer, Trisenox and Amnolake for acute promyelocytic leukemia, Defiterio for sinusoidal obstruction syndrome); the Functional Food segment supplies health food ingredients, preservatives, protein preparations, nutritional supplements, seasonings, spices, and sterilization cleaning agents. Founded in 1919 and headquartered at 14 Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto, Japan, Nippon Shinyaku focuses on high-unmet-need areas including rare diseases, neurology, immunology, and oncology, serving healthcare providers, patients, and consumer markets globally. Recent developments include the January 2025 exclusive partnership with REGENXBIO to develop and commercialize RGX-121 and RGX-111 gene therapies for mucopolysaccharidosis (Hunter and Hurler syndromes) in the U.S. and Asia ($110 million upfront, up to $700 million in milestones and royalties); a September 2024 binding term sheet with Capricor Therapeutics for European commercialization of deramiocel (CAP-1002) for Duchenne muscular dystrophy cardiomyopathy ($20 million upfront, $15 million equity investment, up to $715 million milestones); 2024 launches of Vyxeos, Jaypirca, and pediatric Uptravi in Japan; a January 2025 option agreement with AB2 Bio for tadekinig alfa in NLRC4 mutation and XIAP deficiency (U.S. commercialization); a July 2025 strategic alliance with Boston Children's Hospital; FDA designations in 2025 for NS-051/NCNP-04 (orphan and rare pediatric for Duchenne muscular dystrophy), NS-229 (orphan and fast track for eosinophilic granulomatosis with polyangiitis), and buloxibutid (orphan for idiopathic pulmonary fibrosis in Japan); submission of NS-401 (tagraxofusp) NDA in Japan; and the 7th Five-Year Medium-Term Management Plan announced in May 2024 emphasizing global growth in DMD products, hematologic cancers, U.S./China expansion, and lifecycle management.