What STELLA PHARMA does

STELLA PHARMA (TSE Growth: 4888) is a Japan-based, publicly traded specialty pharmaceutical company founded in 2007 as a vehicle to commercialize Boron Neutron Capture Therapy (BNCT) drugs. The company originated inside Stella Chemifa, the only domestic holder of high-purity boron-10 isotope enrichment technology, and has built its franchise on Steboronine® (borofalan (10B), development code SPM-011) — the world's first BNCT boron pharmaceutical to receive marketing approval (Japan, March 2020) and national health insurance reimbursement (effective May 2020) for unresectable locally advanced or locally recurrent head and neck cancer. The drug pairs an enriched boron-10 compound with external neutron irradiation to selectively destroy cancer cells while sparing surrounding tissue, typically in a single ~40-minute session. The company is actively pursuing indication expansion (recent MAA submissions in March 2026 for angiosarcoma and recurrent high-grade meningioma) and assessing thoracic solid tumors, supported by Phase II data showing median PFS of 14.4 vs 1.4 months in recurrent meningioma and 50% ORR in angiosarcoma.

The business model is a single-asset specialty pharma selling a high-value, reimbursement-covered boron drug directly to BNCT-capable medical institutions, with revenue tightly coupled to the installed base of accelerator-based neutron irradiation systems. Go-to-market is sales-led and education-driven: Stella Pharma co-hosts symposia at major Japanese oncology and head-and-neck surgical societies with Sumitomo Heavy Industries (manufacturer of the NeuCure™ BNCT treatment system), runs physician webinars (120+ participants), and supports patient education. Distribution is direct to a small number of treatment centers in Japan (Osaka Medical and Pharmaceutical University Kansai BNCT Medical Center, Minami Tohoku BNCT Research Center, National Cancer Center) and is being extended internationally through the TAE Life Sciences partnership for the USA/Europe and the Pengbo (Hainan) BNCT Hospital in China (opened February 2026, first overseas BNCT site using Japanese-approved pharmaceutical and equipment). The company remains in early commercialization with revenue not publicly disclosed, headcount of 11–50, and faces a material supply-chain disruption following the September 2025 bankruptcy filing of its contract manufacturer.

Name

STELLA PHARMA

Legal name

ステラファーマ株式会社 (STELLA PHARMA CORPORATION)

Website

https://stella-pharma.co.jp

Company type

Public

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

STELLA PHARMA (TSE Growth: 4888) is a Japan-based specialty pharmaceutical company developing Steboronine®, the world's first approved Boron Neutron Capture Therapy (BNCT) boron drug, sold to BNCT treatment centers and hospitals for head and neck cancer and pipeline oncology indications in Japan, China, the US, and Europe.

Ownership category

akta.pro rank

Product category

Radiation Therapy Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy) (HLAIAGAB)

akta.pro secondary industries

Radiopharmacy Compounding & Dispensing (Hospital/Commercial) (HLAIAGAE), Radiation Oncology (HLAKAFAC)

Keywords

• BNCT pharmaceuticals
• Radiation oncology drugs
• Boron drug development
• Neutron capture therapy
• Cancer therapy products

Headquarters

HQ city

Osaka

HQ country

Japan

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D

Revenue model

1. Pharmaceutical Sales - Steboronine®: Sale of BNCT boron pharmaceutical drugs (Steboronine®) for treatment of unresectable locally advanced or locally recurrent head and neck cancer. The drug is used in combination with neutron irradiation systems at BNCT treatment facilities.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

STELLA PHARMA develops and commercializes pharmaceutical drugs for Boron Neutron Capture Therapy (BNCT), a radiation therapy that combines a boron-containing drug with neutron irradiation to selectively destroy cancer cells. Its core product, Steboronine® (borofalan (10B), SPM-011), is the world's first approved BNCT boron pharmaceutical, approved in Japan in March 2020 for unresectable locally advanced or locally recurrent head and neck cancer. The company supplies the drug to medical institutions equipped with accelerator-based neutron irradiation systems (such as Sumitomo Heavy Industries' NeuCure™), enabling single-session targeted cancer treatment.

Product overview

STELLA PHARMA is a pharmaceutical company specializing in BNCT (Boron Neutron Capture Therapy) drugs. The company's core product is Steboronine® (development code SPM-011), the world's first approved BNCT pharmaceutical containing enriched boron-10. This drug is used in combination with accelerator-based neutron irradiation systems (such as Sumitomo Heavy Industries' NeuCure™) to selectively destroy cancer cells. BNCT represents a new category of radiation therapy where a single treatment session can complete treatment, targeting cancer cells while preserving surrounding healthy tissue. The company is pursuing indication expansions for recurrent meningioma, angiosarcoma, recurrent high-grade meningioma, and solid tumors.

Differentiator

Problem solved

Functional benefit

Brands

• Steboronine (ステボロニン): BNCT (Boron Neutron Capture Therapy) boron pharmaceutical product; the world's first approved BNCT drug. Approved in Japan in March 2020 for unresectable locally advanced or locally recurrent head and neck cancer.

Products and services

• Steboronine® (ステボロニン®) / Borofalan (10B) / SPM-011 World's first approved BNCT (Boron Neutron Capture Therapy) pharmaceutical drug containing enriched boron-10 (borofalan), used in combination with neutron irradiation for targeted cancer treatment. Approved for unresectable locally advanced or locally recurrent head and neck cancer. Sold to BNCT-equipped medical institutions.
• BNCT (Boron Neutron Capture Therapy) Treatment System Supply Integrated BNCT treatment offering that pairs STELLA PHARMA's Steboronine® drug with accelerator-based neutron irradiation systems (e.g., Sumitomo Heavy Industries' NeuCure™). When boron-10 absorbs thermal neutrons, it produces alpha particles and lithium nuclei that selectively destroy cancer cells while minimizing damage to surrounding healthy tissue. Treatment is typically completed in a single session of approximately 40 minutes.

Quantifiable outcome

• Head and neck cancer treatment outcomes: Tumor shrinkage confirmed in all reported BNCT treatment cases at insurance-covered facilities
• +2 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Twelve partnerships are on record, tiered core, flagship and minor.

• Pengbo (Hainan) BNCT Hospital / 鵬博(海南)BNCTセンターcoreGTM or Marketing Partner · 7 February 2026First overseas BNCT facility to use Japanese-approved pharmaceuticals and medical equipment. Located in Hainan Boao Lecheng International Medical Tourism Pilot Zone, China. Stella Pharma supplies BNCT drugs; facility officially opened February 2026 with Sumitomo Heavy Industries BNCT system installed.
• Sumitomo Heavy Industries Co., Ltd. (住友重機械工業株式会社)coreStrategic or Co-development Partner · 13 November 2024Joint development and commercialization partnership for BNCT treatment systems in Japan and globally. Sumitomo Heavy Industries develops and manufactures accelerator-based neutron irradiation systems (NeuCure™) while Stella Pharma supplies the boron pharmaceutical (Steboronine®). The companies jointly conduct clinical trials and promotional activities including academic conference seminars.
• TAE Life Sciences US, LLC (TLS社)flagshipStrategic or Co-development Partner · 13 November 2024Strategic partnership for development and commercialization of BPA (boronophenylalanine) for BNCT cancer therapy in USA and Europe. Signed at TLS headquarters in California, the partnership aims to expand BNCT market in Western regions. CEO Rob from TLS and President Ehara from Stella Pharma participated in signing ceremony.
• Stella Chemifa Co., Ltd. (ステラケミファ株式会社)coreTechnology or IntegrationParent company and exclusive domestic holder of boron isotope enrichment technology in Japan. Provides 10B isotope enrichment capabilities (99%+ concentration) essential for BNCT pharmaceutical production.
• Osaka Metropolitan University (大阪府立大学)minorStrategic or Co-development PartnerAcademic partnership for BNCT research. Professor Kirihata from Osaka Metropolitan University BNCT Research Center collaborated on research and development of boron pharmaceuticals.
• Kyoto University (京都大学)minorStrategic or Co-development PartnerAcademic partnership for BNCT research and development. Kyoto University Research Reactor was used for early BNCT clinical research. Company leveraged Kyoto University research as foundation for drug development.
• Osaka Medical and Pharmaceutical University Kansai BNCT Medical Center (大阪医科薬科大学関西BNCT共同医療センター)coreStrategic or Co-development PartnerPrimary BNCT treatment facility in Japan; key site for clinical trials and treatment delivery. Professor Aihara from the center serves as key opinion leader and frequently presents BNCT clinical data at conferences.
• National Cancer Center Central Hospital (国立がん研究センター中央病院)coreStrategic or Co-development PartnerLeading cancer treatment hospital conducting BNCT treatments and clinical trials. Dr. Igaki from the hospital participates in BNCT education and awareness activities, including TV media appearances.
• Japan Agency for Medical Research and Development (AMED) / 国立研究開発法人日本医療研究開発機構minorStrategic or Co-development PartnerGovernment research funding agency providing support for BNCT drug development. Company received A-STEP and ACT-M program support for clinical development and novel formulation research.
• Sagamihara General Hospital (湘南鎌倉総合病院)minorStrategic or Co-development PartnerResearch collaboration on enhanced proton beam therapy using boron compounds. Company provides reagents for research study on cell killing effect enhancement published in Scientific Reports.
• CICS Co., Ltd. (株式会社CICS)minorStrategic or Co-development PartnerJoint clinical trial partnership for BNCT treatment of angiosarcoma. CICS provides neutron irradiation system (CICS-1) while Stella Pharma supplies boron drug (SPM-011) for Phase II clinical trial.
• China Biotech Services Holdings Limited / 中国生物科技服務控股有限公司 (Hong Kong Stock Exchange: 8037)flagshipGTM or Marketing PartnerChinese partner company for Hainan Island BNCT center operations. Publicly listed company managing Pengbo BNCT hospital in Boao Lecheng zone. Awarded recognition for BNCT technology at 6th China International Consumer Goods Expo.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Sumitomo Heavy Industries: Manufacturer of the NeuCure™ accelerator-based BNCT system used in conjunction with Steboronine®; a strategic co-development partner but also an adjacent competitor/ecosystem gatekeeper in the BNCT value chain.
• Novartis (Pluvicto / Radioligand Therapy): Leader in therapeutic radiopharmaceuticals (e.g., Pluvicto for prostate cancer, Lutathera) — overlaps with Stella Pharma's targeted radionuclide therapy positioning in oncology.
• Bayer (Xofigo / Radiopharmaceuticals): Major radiopharmaceutical player with Xofigo (Ra-223) for bone metastases — comparable therapeutic radiopharmaceutical business with established oncology distribution.

Direct peers

• TAE Life Sciences: US-based BNCT company developing accelerator systems and BPA-based boron drugs; signed a strategic partnership with Stella Pharma in Nov 2024 to commercialize BPA in USA/Europe — directly comparable BNCT drug-and-device player.
• Lantheus Holdings: US-listed radiopharmaceutical company specializing in diagnostic and therapeutic radioisotopes — comparable business model in radiopharma drug development and commercialization.
• Telix Pharmaceuticals: Radiopharmaceutical company developing diagnostic and therapeutic agents (e.g., Illuccix, TLX591) — directly comparable in targeted radioisotope drug development pipeline.
• ITM Isotope Technologies Munich: Manufacturer of medical radioisotopes (including Lu-177) and developer of targeted radiopharmaceuticals — comparable in isotope-based oncology therapeutics.

Others

• Cardinal Health (Radiopharmaceutical Distribution): Operates one of the largest radiopharmacy networks (Nuclear & Precision Health Solutions) — relevant ecosystem peer for distribution/compounding of short-lived radioisotope drugs.
• PETNET Solutions (Siemens Healthineers): Radiopharmacy network producing PET tracers and distributing radiopharmaceuticals — relevant comparator for commercial-scale isotope drug distribution logistics.

Regional players

• Ion Beam Applications (IBA): Belgian proton therapy equipment manufacturer; adjacent player in particle-beam radiation therapy ecosystem relevant to BNCT's positioning vs proton therapy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds2 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about STELLA PHARMA