- CEO
- Fuminori Yoshida
- Full Time Employees
- 91
- Sector
- Health technology
- Industry
- Pharmaceuticals: major
- Address
- Toranomon Towers Office Tokyo TY Japan 105-0001
- IPO Date
- Oct 20, 2011
- Business
- SymBio Pharmaceuticals Limited (4582.T), a specialty pharmaceutical company, engages in the research, development, manufacturing, and commercialization of novel therapeutics targeting unmet medical needs in oncology, hematology, and viral infectious diseases, primarily through in-licensing late-stage assets from U.S. and European biotech firms. The company markets TREAKISYM (bendamustine HCl), an alkylating agent available in lyophilized powder, ready-to-dilute (RTD) liquid, and rapid-infusion (RI) formulations indicated for relapsed/refractory low-grade non-Hodgkin's lymphoma (NHL), mantle cell lymphoma (MCL), untreated low-grade NHL/MCL, chronic lymphocytic leukemia (CLL), and relapsed/refractory diffuse large B-cell lymphoma (DLBCL), often in combination with rituximab or polatuzumab vedotin (P-BR regimen); it also advances a pipeline including brincidofovir (SyB V-1901/BCV IV), a broad-spectrum antiviral nucleotide analog against double-stranded DNA viruses in Phase III for post-hematopoietic stem cell transplant adenovirus infections (AdV), Phase IIa for cytomegalovirus (CMV), Phase Ib/II for malignant lymphomas including NK/T-cell lymphoma, and preclinical studies for glioblastoma, head/neck cancers, multiple sclerosis, and neurodegenerative disorders like Alzheimer's. Founded in 2005 and headquartered in Toranomon, Tokyo, Japan, with a U.S. subsidiary SymBio Pharma USA, Inc. in Durham, North Carolina, SymBio operates principally in Japan while pursuing global development and partnerships in the U.S., Europe, UK, Asia, and beyond. Recent developments include settlement of patent infringement litigation with generic TREAKISYM competitors in 2024-2025 amid a market shift where generics capture approximately 70-80% share; termination of a prior Chimerix license in April 2024 followed by rights transfer to Emergent BioSolutions; initiation of global Phase Ib/II BCV trials for lymphomas (FPI in Japan, expansion to Singapore/Hong Kong), Phase IIa CMV trial (19 patients enrolled), and Phase III AdV application to EMA (targeting NDA in H2 2028); preclinical data presentations at ESMO 2025 (head/neck cancer) and SNO 2025 (glioblastoma) with biomarker identification; and funding via 65th-67th stock acquisition rights (JPY8.4bn net, August 2025) plus unsecured bonds (JPY1.3bn) for BCV development and bond redemption.