SymBio Pharmaceuticals

What SymBio Pharmaceuticals does

SymBio Pharmaceuticals Limited is a Tokyo-based specialty pharmaceutical company founded in March 2005 and listed on the Tokyo Stock Exchange (ticker: 4582, originally listed on the JASDAQ Growth Market in October 2011). The company develops and commercializes therapeutic products for underserved areas of oncology, hematology, infectious diseases, and neurology, with a portfolio centered on two franchises: TREAKISYM (bendamustine hydrochloride), a marketed chemotherapy agent approved in Japan for relapsed/refractory non-Hodgkin lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia, which captured 50% patient share within 12 months of launch and is sold through the company's own hospital sales force since December 2020; and intravenous Brincidofovir (IV BCV), a broad-spectrum antiviral DNA polymerase inhibitor in global Phase III development for adenovirus infection in hematopoietic stem cell transplant recipients, with parallel programs in BK virus, JC virus/PML, EBV-PTLD, multiple sclerosis, malignant lymphoma, head and neck cancer, brain tumors, and Alzheimer's disease. Rigosertib (for myelodysplastic syndrome) is licensed in Japan/Korea from Onconova Therapeutics.

The business model combines proprietary product sales (TREAKISYM in Japan), out-licensed distribution (Eisai for Asia, Astellas/AstraZeneca for Europe), milestone and royalty revenue from co-development agreements, and academic collaboration-funded research with institutions including NIH/NINDS, NIH/NIAID, the University of Tokyo, Kyoto University, Brown University, UCSF, Penn State, and Tufts University. The company has secured FDA Fast Track designation (April 2021), EMA Orphan Drug designation (March 2024), and MHLW Orphan Drug designation (September 2025) for IV BCV, with IV BCV use patents extending US exclusivity to 2044 and a separately patented pico-level sensitivity immunoassay. SymBio operates a wholly-owned US subsidiary (SymBio Pharma USA, established 2016) and runs global Phase III trials across the UK, Spain, Germany, France, Australia, Japan, and Singapore, with a workforce of 51-100 employees concentrated at its Toranomon headquarters in Tokyo.

Name

SymBio Pharmaceuticals

Legal name

SymBio Pharmaceuticals Limited

Website

https://symbiopharma.com

Company type

Public

Founded year

2005

Operating status

Operating

Headcount range

51–100 employees

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Oncology & Hematology Pharmaceuticals (HLAIAAAC)

akta.pro secondary industries

Infectious Disease Specialty Pharmaceuticals (Non-vaccine) (HLAIACAM), Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE)

Keywords

• Specialty pharmaceuticals
• Oncology drug development
• Antiviral therapeutics
• Hematology medicines
• Orphan disease drugs

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Pharmaceutical Product Sales (TREAKISYM): Revenue generated from sales of TREAKISYM (Bendamustine), approved in Japan for treatment of relapsed/refractory non-Hodgkin lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, and as first-line treatment for low-grade NHL. The company transitioned to self-distribution in December 2020, building its own sales infrastructure. Products include RTD (Ready-to-Dilute) and RI (Rapid Infusion) formulations. Global sales partnerships exist with Eisai (Japan, Korea, Singapore), AstraZeneca (Europe), Cephalon (US origin), and distributors across Asia.
2. Brincidofovir (IV BCV) Development Pipeline: BCV is currently in Phase III clinical trials globally for adenovirus infection in hematopoietic stem cell transplant patients. Once approved, BCV will generate revenue as a specialty pharmaceutical. BCV has received Orphan Drug Designation from MHLW (Japan, September 2025) and EMA (EU, March 2024). FDA Fast Track designation was granted in April 2021. Multiple indications are being pursued across infectious diseases, oncology, and neurology.
3. Licensing and Milestone Revenue: Revenue from licensing agreements with pharmaceutical partners including Eisai (for SyB L-0501 bendamustine), Onconova (for Rigosertib), and other international partners. Milestone payments are received upon achievement of clinical, regulatory, and commercial milestones.
4. Academic Collaboration and Grant Revenue: The company conducts joint research with academic institutions (National Cancer Center, University of Tokyo, Kyoto University, Brown University, UCSF, Penn State, Tufts University, etc.) funded through government grants and collaborative research agreements.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels6 records

Core offering

SymBio Pharmaceuticals develops and commercializes specialty pharmaceutical products for underserved therapeutic areas in oncology, hematology, and infectious diseases. Its core commercial product is TREAKISYM (bendamustine hydrochloride), approved in Japan for relapsed/refractory non-Hodgkin lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia. Its lead pipeline asset is Brincidofovir (IV BCV), a broad-spectrum antiviral in global Phase III trials targeting adenovirus infection in hematopoietic stem cell transplant patients, with additional development programs across BK virus, JC virus/PML, EBV, and oncology indications.

Product overview

SymBio Pharmaceuticals is a Japanese specialty pharmaceutical company focused on developing and commercializing drugs for underserved therapeutic areas in oncology and hematology. The company operates a proprietary drug discovery business model combined with global partnerships. The core product portfolio centers on TREAKISYM (bendamustine hydrochloride) for lymphoma treatment, Brincidofovir (BCV) as a broad-spectrum antiviral in late-stage global development, and Rigosertib for myelodysplastic syndrome. The company has expanded Brincidofovir development across multiple therapeutic areas including post-transplant viral infections, Progressive Multifocal Leukoencephalopathy (PML), and oncology applications. Pipeline candidates include SyB V-1901 and SyB L-1701/L-1702. SymBio also has international operations through its US subsidiary SymBio Pharma USA and partnerships with companies including Onconova Therapeutics, Eisai, and academic institutions.

Differentiator

Problem solved

Functional benefit

Brands

• Treakisym: Anti-cancer drug (bendamustine hydrochloride) for treatment of malignant lymphoma, chronic lymphocytic leukemia, and other hematologic malignancies
• Brincidofovir (BCV/IV BCV)

Products and services

• TREAKISYM (bendamustine hydrochloride) Anti-malignant tumor agent (bendamustine hydrochloride) approved in Japan for treatment of relapsed/refractory diffuse large B-cell lymphoma, low-grade non-Hodgkin lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia. Available in RTD (Ready-to-Dilute) and RI (Rapid Infusion) formulations. Prescribed by hematologists and oncologists at hospitals and cancer centers.
• Brincidofovir (BCV/IV BCV) Broad-spectrum antiviral injection targeting multiple DNA viruses including adenovirus (AdV), BK virus, cytomegalovirus (CMV), JC virus (PML), and EBV. In global Phase III for adenovirus infection post-hematopoietic stem cell transplantation. Also under development for oncological applications including malignant lymphoma, head and neck cancer, brain tumors, EBV-associated gastric cancer, and neurological conditions (multiple sclerosis, PML, Alzheimer's). Has received FDA Fast Track, EMA Orphan Drug, and MHLW Orphan Drug designations.
• Rigosertib (SyB L-1101/SyB C-1101) Anticancer agent available in both injection and oral formulations, being developed for myelodysplastic syndrome (MDS) and other hematological malignancies. Licensed from Onconova Therapeutics under a partnership where SymBio holds Japan and certain Asian market rights.
• SyB L-0501 (SymBenda) Bendamustine product marketed in Singapore and Hong Kong under the international brand name SymBenda for low-grade non-Hodgkin lymphoma and chronic lymphocytic leukemia.

Quantifiable outcome

• TREAKISYM achieved 50% market share among target patients within 12 months of launch (2011)
• +3 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

21 partnerships are on record, tiered core and minor.

• NIH (general - Progresive Multifocal Leukoencephalopathy)coreStrategic or Co-development Partner · 2 February 2026CRADA for clinical trials of IV BCV targeting Progressive Multifocal Leukoencephalopathy (PML). FPI (First Patient In) achieved June 2026. PML is a rare, progressive neurological disease with no approved treatments, caused by JC virus in immunocompromised patients.
• Tufts University (USA)coreTechnology or Integration · 25 December 2024Acquired global exclusive rights from Tufts University for IV BCV for Alzheimer's disease treatment (December 2025). This represents a major expansion of BCV's therapeutic application into the large neurodegenerative disease market. Tufts University research provided the scientific foundation for this new indication.
• Penn State University (USA)coreTechnology or Integration · 24 December 2024Acquired global exclusive rights for IV BCV in treatment of polyomavirus infections from Penn State University (December 2025). Penn State's research on polyomavirus models demonstrated BCV's effectiveness in suppressing infectious virus production. Builds on existing polyomavirus development program (BK virus, JC virus).
• NIH/NIAID (National Institute of Allergy and Infectious Diseases)coreStrategic or Co-development Partner · 24 April 2023CRADA for assessment of efficacy of Brincidofovir for Epstein-Barr Virus Associated Lymphoproliferative Disease (EBV-PTLD). Extended for 3 years in May 2026. Addresses significant unmet need in transplant patients who develop EBV-associated lymphoproliferative disease.
• NIH/NINDS (National Institute of Neurological Disorders and Stroke)coreStrategic or Co-development Partner · 22 March 2023CRADA (Cooperative Research and Development Agreement) for development of Brincidofovir for Multiple Sclerosis. Extended for 3 years in March 2026. Research published in Journal of Clinical Investigation demonstrating BCV's mechanism in MS. Collaboration leverages NIH's neurological expertise and infrastructure for clinical trials targeting progressive MS and related conditions.
• National Institute of Infectious Diseases (Japan)minorStrategic or Co-development Partner · 19 December 2022Commissioned research contract for efficacy validation of brincidofovir in viral infection brain tissue models. Japanese government-affiliated research institution supporting domestic clinical development.
• Penn State University College of MedicineminorStrategic or Co-development Partner · 24 November 2022Sample provision agreement for validation studies of brincidofovir effectiveness in polyomavirus infection models. Preclinical validation work supporting clinical development for BK virus and JC virus indications.
• NIH/NINDS (Sample Provision)minorStrategic or Co-development Partner · 9 August 2022Sample provision agreement with NIH for preclinical studies of brincidofovir against Epstein-Barr virus. Enables access to NIH's research resources and viral expertise for EBV-related disease research.
• National Cancer Center JapanminorStrategic or Co-development Partner · 1 April 2022Collaborative research agreement on rare cancers with National Cancer Center. Focuses on development of therapies for rare and orphan oncology indications, leveraging NCC's clinical trial infrastructure and patient population.
• Brown University (USA)minorStrategic or Co-development Partner · 7 March 2022Nonclinical research collaboration for Brincidofovir injection in brain tumors. Preclinical studies conducted with Brown University's neurosurgery/neuro-oncology department to evaluate BCV's potential in glioblastoma and other brain malignancies.
• University of TokyominorStrategic or Co-development Partner · 6 January 2022Collaborative research agreement and social collaboration chair 'Molecular Tumor Pharmacology' established with the University of Tokyo's Institute of Medical Science. Joint research program focused on molecular mechanisms of anticancer drug action and tumor biology.
• UCSF (University of California, San Francisco) Brain Tumor CenterminorStrategic or Co-development Partner · 8 September 2021Investigator-initiated study for new indication of Brincidofovir injection in brain tumors. UCSF's neuro-oncology team conducting exploratory clinical evaluations of BCV's anticancer potential.
• Singapore National Cancer Centre (NCCS)minorStrategic or Co-development Partner · 1 September 2021Joint research agreement for investigation of Brincidofovir injection for anticancer applications. Leverages Singapore's position as a regional clinical trial hub and expertise in oncology research.
• Kyoto UniversityminorStrategic or Co-development Partner · 2 August 2021Joint research with Kyoto University on the mechanism of action of bendamustine in diffuse large B-cell lymphoma (DLBCL). Investigates how bendamustine induces therapeutic responses to optimize treatment strategies.
• Gunma University (Japan)minorStrategic or Co-development Partner · 15 July 2021Collaborative research on exploration of new indications for bendamustine and rigosertib. Gunma University researchers investigating novel applications for these agents in additional hematological malignancies.
• Chimerix (Emergent BioSolutions)coreOEM/ Whitelabel/ Licensing Partner · 1 October 2019Global license agreement for brincidofovir acquired from Chimerix (now Emergent BioSolutions). SymBio obtained global rights for all indications of BCV. Chimerix received FDA approval for Tembexa (brincidofovir) for smallpox in 2021. SymBio holds exclusive rights for human therapeutic uses outside the smallpox indication.
• AstraZeneca (Europe)minorChannel Partner/ Reseller/ Distributor · 21 September 2017Bendamustine liquid formulation licensing agreement with AstraZeneca for Europe. Leverages AstraZeneca's established European oncology distribution network for bendamustine products.
• Onconova Therapeutics (USA)coreOEM/ Whitelabel/ Licensing Partner · 11 July 2011Licensing agreement for rigosertib (SyB L-1101/SyB C-1101), an anticancer agent developed by Onconova. SymBio holds rights for Japan and certain Asian markets; Onconova retains global rights outside these territories. INSPIRE Phase III trial conducted globally for high-risk MDS. Rigosertib's injection formulation and oral formulation both licensed to SymBio.
• Eisai (Japan)coreChannel Partner/ Reseller/ Distributor · 18 May 2009Licensing agreement for bendamustine (SyB L-0501) in Japan, Korea, and Singapore. Eisai distributes TREAKISYM in Japan as part of the original partnership. SymBio transitioned to self-distribution for Japan in December 2020 while Eisai retained distribution rights in Korea and Singapore.
• Avelere Pharma / Acella Pharma (USA)minorOEM/ Whitelabel/ Licensing Partner · 16 March 2007In-licensing of antiemetic product (SyB D-0701), a transdermal sustained-release antiemetic agent for chemotherapy-induced nausea. Development code SyB D-0701. Phase II clinical trial completed (2012).
• Astellas Pharma (Germany/Japan)coreChannel Partner/ Reseller/ Distributor · 22 December 2005Original in-licensing of bendamustine (SyB L-0501) from Astellas Pharma (formerly Astellas Deutschland/formerly Yamanouchi). Astellas granted rights to SymBio for development and commercialization in Japan. Astellas also distributes in Europe through its own network.

Scale indicators7 records

Recent moves3 records

Expansion highlights6 records

Direct peers

• Jazz Pharmaceuticals: Ireland/US specialty pharma with focus on hematology/oncology and rare diseases, including CNS adjacencies. SymBio's bendamustine franchise, BCV in transplant viral infections, and rigosertib in MDS all overlap with Jazz's specialty positioning and orphan-drug economics.
• Onconova Therapeutics: SymBio's exclusive licensor and development partner for rigosertib globally; SymBio holds Japan/Asia rights while Onconova owns the rest of the world. SymBio and Onconova co-developed the INSPIRE Phase III program in higher-risk MDS and share commercial economics on a shared pipeline asset.
• Helsinn Group: Swiss specialty pharma with historical bendamustine licensing activity and oncology supportive-care portfolio. SymBio's European bendamustine distribution via AstraZeneca overlaps with Helsinn's commercial footprint in the same European hospital channel.

Broad incumbents

• Astellas Pharma: Originally in-licensed bendamustine to SymBio in 2005 and remains a distributor/partner in Europe. Larger incumbent with overlapping hematology/oncology franchise and transplant-related therapeutic interests; comparable as SymBio's founding licensor and channel partner.
• Chimerix / Emergent BioSolutions (brincidofovir originator): Chimerix originally developed brincidofovir and sold the global license to SymBio in 2019; the asset was later acquired via Chimerix's combination with Emergent BioSolutions. Tembexa (oral BCV) is FDA-approved for smallpox under their control. Most direct comparable for SymBio's BCV program given shared molecule history and identical mechanism.
• Incyte: US specialty biotech with strong hematology/oncology franchise (Jakafi in myeloproliferative neoplasms, MDS-adjacent) and orphan-drug commercial expertise. Comparable as a mid-sized publicly traded biotech that built a sustainable commercial franchise from hematology/oncology rare-disease assets.

Regional players

• Nippon Kayaku: Japanese specialty pharmaceutical company with overlapping focus on oncology, including hematology products. Comparable to SymBio as a Japan-domiciled specialty pharma developing and commercializing oncology/hematology assets with US/global ambitions.
• Mundipharma: Global pharmaceutical company that has held international bendamustine rights (Levact/Ribomustin) outside the US/Japan. Comparable as a complementary regional rights-holder for the same bendamustine molecule in non-overlapping geographies.
• Sawai Group Holdings: Major Japanese specialty/generic pharmaceutical company with growing oncology and specialty pipeline presence. Comparable peer in terms of size (~mid-cap Japan pharma), Tokyo Stock Exchange listing, and domestic specialty drug commercialization strategy.

Emerging players

• AlloVir (acquired by) / Elevance Biotech / Vera Therapeutics pivot: AlloVir was publicly cited alongside SymBio in the DelveInsight BK virus pipeline report as a key competitor. They focus on virus-specific T-cell therapies for transplant-related viral infections — direct overlap with SymBio's BCV-targeted transplant antiviral strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds13 records

Investors20 records

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M&A

Investments

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Frequently asked questions about SymBio Pharmaceuticals