SBI Pharmaceuticals

What SBI Pharmaceuticals does

SBI Pharmaceuticals Co., Ltd. is a Japanese specialty pharmaceutical company founded in 2008 as a wholly-owned subsidiary of SBI Holdings (TSE: 8473), dedicated exclusively to the development and commercialization of products based on 5-aminolevulinic acid (5-ALA). The company leverages 5-ALA's biochemical property of being metabolized to protoporphyrin IX, which selectively accumulates in tumor cells and fluoresces under specific blue light wavelengths, to enable photodynamic diagnosis (PDD) and photodynamic therapy (PDT). Its commercial product portfolio comprises orally administered diagnostic agents ALAGLIO Divided Granules 1.5g (for non-muscle invasive bladder cancer), ALAGLIO Internal Medicine 1.5g / Alabel Oral 1.5g (for malignant glioma), companion medical light source devices Aladuck 405/II and Claritron single-use urology endoscopes, and consumer products (cosmetics and supplements under the Alaplus brand) channeled through sister company SBI ALApromo. The company employs approximately 68 people (as of February 2020), outsources all manufacturing, and operates from Tokyo headquarters and an R&D facility at King Sky Front in Kawasaki.

SBI Pharmaceuticals operates a hybrid business model: it generates revenue through direct sales of medical devices and ALAGLIO products, through licensing royalties from exclusive distribution partners (most prominently Chugai Pharmaceutical, which holds exclusive Japan marketing rights for ALAGLIO Divided Granules 1.5g for bladder cancer), through four additional international licensing arrangements (including Neopharma for MENA and India), and through its sister company network spanning photonamic (Germany/Netherlands), NXDC (USA), and SBI ALApharma Canada. Pricing of ALAGLIO products is supported by Japan's National Health Insurance Drug Price List and DPC reimbursement codes, including a 500-point intraoperative vascular imaging addition for photodynamic diagnosis procedures. The company is currently advancing a Phase III ovarian cancer trial (ASTROPIC) and holds orphan drug designations from Japan's MHLW and the European Commission for 5-ALA in ovarian cancer.

Name

SBI Pharmaceuticals

Legal name

SBI Pharmaceuticals Co., Ltd.

Website

https://sbipharma.co.jp

Company type

Private

Founded year

2008

Operating status

Operating

Short description

SBI Pharmaceuticals is a Japanese specialty pharmaceutical subsidiary of SBI Holdings that develops and commercializes diagnostics and devices based exclusively on 5-aminolevulinic acid (5-ALA) for cancer surgery visualization, with operations in Japan, Europe, and North America.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Surgical Appliance and Supplies Manufacturing (339113), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841), Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Primary Care & General Medicine Pharmaceuticals (HLAIAAAA)

akta.pro secondary industry

Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity) (HLAIAAAE)

Keywords

• Photodynamic diagnostic agents
• Medical light source devices
• 5-aminolevulinic acid pharmaceuticals
• Urology endoscopy equipment
• Oncology fluorescence imaging

Headquarters

HQ city

Roppongi

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: Direct manufacturing and sales of ALAGLIO® products - photodynamic diagnostic agents for bladder cancer and malignant glioma. Manufacturing is outsourced, company handles development and marketing.
2. Licensing Royalties: Licensed exclusive sales rights for ALAGLIO® Divided Granules 1.5g to Chugai Pharmaceutical in Japan. Four other international licensing arrangements for various territories and indications.
3. Medical Device Sales: Sale of medical light source devices (Aladuck 405/II) and Claritron single-use urology endoscopes for use with photodynamic diagnosis procedures.
4. Health Food and Cosmetics: 5-ALA supplements and cosmetics sold through sister company SBI ALApromo. Products include Alaplus Skincare and various health supplements containing 5-ALA.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels4 records

Core offering

SBI Pharmaceuticals develops, manufactures (via outsourcing), and commercializes pharmaceuticals and medical devices based on its proprietary 5-aminolevulinic acid (5-ALA) platform. Core products include photodynamic diagnostic agents (ALAGLIO Divided Granules 1.5g, ALAGLIO Internal Medicine 1.5g, Alabel Oral 1.5g) for fluorescence-guided cancer surgery, medical light source devices (Aladuck 405/II), and single-use urology endoscopes (Claritron). The company also supplies the active ingredient for health foods, cosmetics, and animal feed products marketed by sister companies.

Product overview

SBI Pharmaceuticals is a specialty pharmaceutical company focused exclusively on 5-ALA (5-aminolevulinic acid) technology. The company operates a multi-category product portfolio including: pharmaceuticals (photodynamic diagnostic agents ALAGLIO® Divided Granules 1.5g and ALAGLIO® Internal Medicine 1.5g for cancer surgery visualization); medical devices (Aladuck 405/II light source and Claritron single-use endoscopes); and consumer products (Alaplus Skincare cosmetics). All products leverage the unique properties of 5-ALA which accumulates in tumor cells and produces fluorescence under specific light wavelengths. The company also maintains a development pipeline spanning oncology, mitochondrial disease, ischemia-reperfusion injury, and animal health applications.

Differentiator

Problem solved

Functional benefit

Brands

• ALAGLIO: Photodynamic diagnostic agent for bladder cancer and malignant glioma containing 5-aminolevulinic acid
• Alabel
• Aladuck
• Claritron

Products and services

• ALAGLIO Divided Granules 1.5g Photodynamic diagnostic agent for non-muscle invasive bladder cancer. Tumor cells become fluorescent under specific blue light wavelengths, enabling surgeons to better detect tumors during transurethral resection (TURBT) procedures. Marketed in Japan through Chugai Pharmaceutical.
• ALAGLIO Internal Medicine 1.5g Orally-administered in vivo diagnostic agent for malignant glioma (brain tumor). Used for photodynamic diagnosis during surgical resection to visualize tumor tissues.
• Alabel Oral 1.5g Photodynamic diagnostic agent for bladder cancer. SBI Pharmaceuticals took over marketing authorization from Nobelpharma as of October 1, 2024, and now markets the product in Japan.
• Aladuck 405/II Medical light source device for photodynamic diagnosis. Emits specific wavelengths of light to excite fluorescent protoporphyrin IX accumulated in tumor cells. Registered as Class II medical device with the U.S. FDA.
• Claritron Single-use urology videoscope including single-use ureteroscope and disposable cystoscope. Distributed exclusively in Japan by SBI Pharmaceuticals under agreement with Scivita Medical.
• Alaplus Skincare Cosmetics and skincare products containing 5-ALA as a moisturizing ingredient for anti-aging use. Distributed via sister company SBI ALApromo's consumer channels.

Quantifiable outcome

• 500 point DPC reimbursement available for photodynamic diagnosis procedures using ALAGLIO® during bladder cancer surgery
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Nine partnerships are on record, tiered core and major.

• Nobelpharma Co., Ltd.coreStrategic or Co-development Partner · 1 October 2024Originally co-developed malignant glioma diagnostic agent. In 2024, Nobelpharma transferred marketing authorization for Alabel® Oral 1.5g to SBI Pharmaceuticals. Historical collaboration on Phase III clinical trials for oral in vivo diagnostic agent for malignant glioma.
• TAGCyx Biotechnologies Inc.majorStrategic or Co-development Partner · 31 January 2024Research and development collaboration to develop innovative products in the field of cancer treatment. Collaboration announced in 2020 and continues through 2024 with milestone achievements announced.
• Scivita MedicalcoreChannel Partner/ Reseller/ Distributor · 28 November 2023Exclusive distributorship agreement for Scivita's Single-Use Urology Videoscope including single-use ureteroscope and disposable cystoscope in Japan. Supports urology product portfolio expansion.
• University of OxfordmajorStrategic or Co-development Partner · 8 March 2021Clinical trial sponsorship agreement for dose-finding Phase II trial combining 5-ALA hydrochloride and Sodium ferrous citrate for mitigation of ischemia-reperfusion injury in cardiac surgery under cardiopulmonary bypass. First patient dosed at John Radcliffe Hospital.
• Neopharma Japan Co., Ltd.majorChannel Partner/ Reseller/ Distributor · 30 March 2018Granted comprehensive commercialization rights on pharmaceuticals containing 5-ALA including ALAGLIO Divided Granules 1.5g in MENA territory and India. Subsidiary of Neopharma LLC, a UAE pharmaceutical company.
• Chugai Pharmaceutical Co., Ltd.coreChannel Partner/ Reseller/ Distributor · 13 March 2017Licensed exclusive marketing rights for ALAGLIO® Divided Granules 1.5g as photodynamic diagnostic agent for bladder cancer in Japan. Chugai launched the product in December 2017 and handles all marketing, sales, and distribution within Japan.
• Neopharma LLCmajorChannel Partner/ Reseller/ Distributor · 26 October 2016Exclusive license agreement for therapeutic drugs for diabetes and malaria infection using 5-ALA technology in specified territories.
• medac GmbHcoreStrategic or Co-development Partner · 5 June 2009Joint venture ALApharma GmbH established (50% each) in Wedel, Germany for pharmaceutical development in Europe. medac contributed Gliolan brain tumor diagnostic agent and European market expertise. Later evolved into photonamic.
• Cosmo Oil Co., Ltd.majorStrategic or Co-development Partner · 27 May 2008Joint venture established with Cosmo Oil contributing 5-ALA production technology (cost reduction process) and SBI Group contributing venture development expertise. Cosmo Oil held 15% stake in SBI ALApromo. Cosmo Oil supplied 5-ALA for various products.

Scale indicators6 records

Recent moves10 records

Expansion highlights6 records

Broad incumbents

• Stryker Corporation: Global medical device company (NYSE: SYK) with significant urology and surgical-imaging presence. Competes broadly in the operating-room surgical-vision and urology-equipment category that overlaps with SBI Pharma's Aladuck and Claritron product lines and indirectly competes for the same hospital purchasing channels.
• Chugai Pharmaceutical Co., Ltd. Major Japanese pharmaceutical company (TSE: 4519, subsidiary of Roche) and exclusive marketing partner for ALAGLIO® Divided Granules 1.5g in bladder cancer. Operates at significantly larger scale across multiple therapeutic areas and shapes the commercial trajectory of SBI Pharma's lead product through its sales force and reimbursement engagement.
• Karl Storz SE & Co. KG: Germany-headquartered global leader in endoscopy for urology and other surgical specialties. Competes with SBI Pharma's Claritron single-use urology endoscope in the same procedural workflow that ALAGLIO® supports, addressing overlapping hospital customers with complementary/adjacent product offerings.
• Nobelpharma Co., Ltd. Japanese specialty pharmaceutical company focused on orphan and unmet-need indications. Nobelpharma was SBI Pharma's co-development partner for the oral in vivo diagnostic agent for malignant glioma and transferred Alabel® Oral 1.5g marketing authorization to SBI Pharma effective October 2024. The two companies operate in overlapping orphan-drug therapeutic areas.
• Olympus Corporation: Japanese global medical device leader with the dominant share of reusable endoscopes in urology and gastroenterology. Olympus competes with SBI Pharma in the medical-device portion of the surgical-urology workflow and offers broader hospital imaging platforms that include PDD-compatible light sources.

Direct peers

• NXDC Corporation: US-based sister company within the SBI ALApharma Group that markets Gleolan® (5-ALA HCl) for intraoperative optical imaging agent during malignant glioma surgery. Operates the same technology platform in the United States and filed a supplemental indication for meningioma surgery in April 2026. Closely comparable to SBI Pharma in product, platform, and pipeline.
• photonamic GmbH: Sister company within the SBI ALApharma Group based in Wedel, Germany. Photonamic develops and markets 5-ALA based products (Gliolan®/Alaglio®) for photodynamic diagnosis of malignant glioma in Europe. Operates the identical 5-ALA technology platform as SBI Pharma in a different geography, making it the closest functional peer.
• SBI ALApharma Canada: Canadian sister company of SBI Pharmaceuticals within the SBI ALApharma Group. Part of the coordinated global 5-ALA commercialization network, with activity in the Canadian regulatory and commercial market. Functions as a geographic twin rather than a competitor but is highly comparable in business activity and product set.

Regional players

• Neopharma LLC: UAE-based pharmaceutical company that holds comprehensive commercialization rights from SBI Pharma for 5-ALA products including ALAGLIO Divided Granules 1.5g in the MENA territory and India. Functions as a licensee rather than a competitor, but operates the identical 5-ALA platform in a defined geographic footprint and is structurally comparable.

Others

• medac GmbH: Germany-based specialty pharmaceutical company with deep expertise in photodynamic therapy and oncology. Original 50/50 joint venture partner with SBI ALApromo to form ALApharma GmbH in Wedel (2009), contributing Gliolan® for brain-tumor diagnosis. Historically a development and commercialization partner; relationship evolved into photonamic but medac remains a peer in oncology and PDD.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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 SBI Pharmaceuticals