Rakuten Medical

What Rakuten Medical does

Rakuten Medical, Inc. is a San Diego-headquartered, privately held clinical-stage biotechnology company founded in 2010 (originally as Aspyrian Therapeutics) by Hiroshi 'Mickey' Mikitani and Miguel Garcia-Guzman. The company develops the Alluminox platform, an investigational photoimmunotherapy technology combining a cell-targeting antibody conjugated to a light-activatable dye (IRDye 700DX) with localized 690nm red-light illumination via the BioBlade Laser System to induce rapid, selective necrosis of cancer cells while sparing surrounding tissue. Its lead product, ASP-1929 (marketed as Akalux in Japan), is an anti-EGFR cetuximab-IR700 conjugate targeting EGFR-expressing solid tumors.

Rakuten Medical's lead asset received conditional marketing approval in Japan in September 2020 under Sakigake and Conditional Early Approval designations for unresectable locally advanced or recurrent head and neck cancer, with commercial launch in January 2021. The company has since administered approximately 900 treatments across roughly 180 sites in all 47 Japanese prefectures, with about 450 trained physicians certified through its Alluminox Certification System. Globally, ASP-1929 is in Phase 3 development (ASP-1929-301 and ASP-1929-381 studies) across approximately 40 sites in the U.S., Taiwan, Japan, India, and Ukraine, with positive Phase 3 ORR (25.8% vs 15.2%) and OS (15.7 vs 9.6 months) data reported at ASCO 2026 supporting a targeted FDA BLA submission in 2028.

The business model is currently anchored on Japanese commercial sales of the ASP-1929 drug and BioBlade device combination under national health insurance reimbursement. Global revenue remains pre-commercial, with future income expected from U.S. (post-2028), Taiwan, MENA (via Hikma licensing), and additional market approvals. The company has raised over $485 million across multiple funding rounds and maintains operations across the U.S. (HQ), Japan, Taiwan, Switzerland, and India, with GMP manufacturing partnerships (LOTTE Biologics), a pipeline including RM-1995 (Phase 1) and RM-0256, and a July 2026 CEO transition to President Minami Maeda to accelerate U.S. commercial execution.

Name

Rakuten Medical

Legal name

Rakuten Medical, Inc.

Website

https://rakuten-med.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

101–250 employees

Short description

Rakuten Medical is a San Diego-based clinical-stage biotechnology company developing the Alluminox platform-based photoimmunotherapy, commercialized in Japan as ASP-1929 plus BioBlade for head and neck cancer, with global Phase 3 trials targeting FDA submission in 2028.

Ownership category

akta.pro rank

Product category

Oncology Therapeutics

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Medical Equipment and Supplies Manufacturing (3391)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Antibody-Drug Conjugates (ADCs) & Antibody Conjugates (HLAAAAAE)

akta.pro secondary industries

Oncology Specialty Pharmaceuticals (HLAIACAA), Oncology & Hematology Pharmaceuticals (HLAIAAAC)

Keywords

• Photoimmunotherapy platform
• Oncology drug development
• Antibody drug conjugates
• Medical laser devices
• Cancer therapeutics

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales (Japan): Revenue from sales of Akalux (ASP-1929) and BioBlade laser system in Japan. The company launched commercial sales in January 2021 and has provided approximately 900 treatments as of May 2025 through approximately 180 treatment sites.
2. Global Pipeline Development: Pre-commercial stage in most markets. The company is advancing ASP-1929 through global Phase 3 trials with planned BLA submission to U.S. FDA in 2028. Future revenue anticipated from regulatory approvals in US, Taiwan, and additional markets.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Rakuten Medical develops and commercializes investigational cancer therapies based on its proprietary Alluminox photoimmunotherapy platform. Its lead product, ASP-1929 (marketed as Akalux in Japan), is an antibody-dye conjugate combining anti-EGFR cetuximab with the IRDye 700DX light-activatable dye, administered alongside the BioBlade Laser System, which delivers 690nm red light to selectively induce necrosis of EGFR-expressing tumor cells. The drug-device combination has received conditional marketing approval in Japan for unresectable locally advanced or recurrent head and neck cancer and is in global Phase 3 development targeting a U.S. FDA BLA submission in 2028.

Product overview

Rakuten Medical is a global biotechnology company developing and commercializing the Alluminox platform-based photoimmunotherapy for cancer treatment. The platform consists of a proprietary drug-device combination: the investigational drug ASP-1929 (Akalux), an antibody-dye conjugate combining cetuximab with IRDye 700DX light-activatable dye, paired with the BioBlade Laser System medical device for 690nm light administration. Together, these components enable selective cancer cell killing through photoimmunotherapy. The company also has pipeline candidates including RM-1995 and RM-0256, and an Alluminox Palette drug discovery program. Akalux and BioBlade are approved in Japan; the company is pursuing global regulatory approvals with a target BLA submission to the U.S. FDA in 2028.

Differentiator

Problem solved

Functional benefit

Brands

• Alluminox®: Proprietary photoimmunotherapy platform combining pharmaceuticals, medical devices, and related technologies for precision cell-targeting cancer treatment
• Alluminox Palette™
• アキャルックス® (Akalux®)
• BioBlade®

Products and services

• ASP-1929 (Akalux) Antibody-dye conjugate pharmaceutical consisting of anti-EGFR antibody cetuximab conjugated to the IRDye 700DX (IR700) light-activatable dye. Approved in Japan for unresectable locally advanced or recurrent head and neck cancer; currently in global Phase 3 trials for additional indications. Administered intravenously and activated by 690nm red light from the BioBlade Laser System to selectively induce necrosis of EGFR-expressing tumor cells.
• BioBlade Laser System Class III medical laser device system used to deliver 690nm red-light activation to ASP-1929 (Akalux) for photoimmunotherapy. Includes the BioBlade Laser, BioBlade Laser WR, frontal/side-fired/cylindrical diffusers, needle catheters, and calibration accessories. Approved in Japan.
• RM-1995 Second-generation photoimmunotherapy drug candidate targeting advanced or recurrent solid tumors with liver metastases. Currently in Phase 1 clinical trial in Japan under AMED funding.
• RM-0256 Anti-PD-L1 antibody-IR700 conjugate for photoimmunotherapy targeting malignant epithelial tumors including melanoma, liver, lung, and breast cancers. Selected for AMED funding and in preparation for clinical trials.

Quantifiable outcome

• Objective Response Rate (ORR): 25.8% vs 15.2% (SOC) in Phase 3 ASP-1929-301 study for recurrent HNSCC
• +4 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered flagship and core.

• 友華集團 (Yuyuan Group/Youryou Group)flagshipStrategic or Co-development Partner · 14 January 2026Partnership to advance Alluminox platform-based photoimmunotherapy for head and neck cancer treatment in Asia. Collaboration expands presence in Taiwan and Asian markets. Strategic partnership announced June 27, 2025.
• LOTTE BiologicscoreStrategic or Co-development Partner · 13 January 2026Manufacturing agreement for monoclonal antibody intermediates and conjugates for Rakuten Medical's Alluminox platform-based photoimmunotherapy. LOTTE Biologics provides GMP-compliant manufacturing through its specialized ADC facility at Syracuse Bio Campus in New York. Partnership addresses increased demand from expanding global clinical program and upcoming commercialization. Deal signed at J.P. Morgan Healthcare Conference in San Francisco.
• Hikma PharmaceuticalsflagshipChannel Partner/ Reseller/ Distributor · 10 August 2023Licensing agreement for MENA (Middle East and North Africa) region. Hikma granted rights to commercialize ASP-1929 photoimmunotherapy for head and neck cancer treatment in MENA markets. Expands geographic reach and leverages Hikma's established regional distribution network.

Scale indicators6 records

Recent moves9 records

Expansion highlights7 records

Broad incumbents

• Daiichi Sankyo: Daiichi Sankyo is the global leader in antibody-drug conjugates (Enhertu, Datroway) developed with AstraZeneca. Comparable to Rakuten Medical as both companies build oncology platforms around antibody conjugates, though Daiichi operates at much larger scale and across multiple therapeutic areas.
• AstraZeneca: AstraZeneca partners with Daiichi Sankyo on Enhertu and Datroway ADCs and competes in head and neck cancer with Imfinzi. Comparable as a large-cap oncology incumbent investing heavily in antibody-conjugate platforms and head and neck cancer indications.
• Pfizer (Seagen): Pfizer acquired Seagen in 2023, gaining Padcev and Tivdak, both ADCs. Comparable to Rakuten Medical as a major pharma player pursuing antibody-conjugate oncology therapies, including in head and neck-adjacent indications like cervical cancer (Tivdak).
• AbbVie (ImmunoGen): AbbVie acquired ImmunoGen for Elahere, an ADC for ovarian cancer, signaling continued commitment to the ADC modality. Comparable as a large oncology player with an antibody-conjugate platform pursuing solid tumor indications.
• Merck & Co. Merck's Keytruda (pembrolizumab) is the dominant immunotherapy in head and neck cancer and is being tested in combination with ASP-1929. Rakuten Medical is actively pursuing a Keytruda combination, making Merck both a potential partner and a competitive threat in HNSCC.
• Bristol-Myers Squibb: BMS markets Opdivo (nivolumab), approved for recurrent/metastatic head and neck cancer. Comparable as a competing immunotherapy option for the same patient population Rakuten Medical is targeting with ASP-1929.

Emerging players

• Mersana Therapeutics: Mersana Therapeutics is a clinical-stage biotech developing next-generation ADCs with proprietary payload and linker technologies. Comparable as a smaller, focused ADC developer advancing multiple solid tumor programs, similar in scale and stage to Rakuten Medical.
• Bolt Biotherapeutics: Bolt Biotherapeutics develops immune-stimulating antibody conjugates (ISACs), combining tumor-targeting antibodies with immune activators. Comparable as a clinical-stage antibody-conjugate biotech with a similar therapeutic mechanism combining targeted antibodies with an activation step.
• HistoSonics: HistoSonics develops histotripsy, a non-invasive sound-based platform for destroying tumor tissue using focused ultrasound. Comparable as an emerging device-driven oncology platform that uses a non-pharmaceutical physical activation mechanism to selectively destroy cancer cells, conceptually analogous to Rakuten Medical's laser-activated drug platform.

Direct peers

• Novocure: Novocure develops Tumor Treating Fields (TTFields), a device-driven cancer therapy that uses alternating electric fields to disrupt cancer cell division. Comparable as a medical-device-plus-treatment-platform oncology company using a physical activation modality (electric fields) paired with cancer-targeting approaches, similar in concept to Rakuten Medical's drug-device photoimmunotherapy model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/rakuten-medical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles23 records

Subsidiaries4 records

Funding overview

Funding rounds13 records

Investors17 records

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M&A1 record

Investments1 record

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Frequently asked questions about Rakuten Medical