Shionogi

What Shionogi does

Shionogi & Co., Ltd. is a Japanese pharmaceutical company founded in 1878 and headquartered in Osaka, listed on the Tokyo Stock Exchange (TSE: 4507) with an unsponsored ADR (OTCMKTS: SGIOY) and a market capitalization of approximately $18 billion. The company operates globally through subsidiaries including Shionogi Inc. (Florham Park, NJ), Shionogi B.V. (Amsterdam), Qpex Biopharma (San Diego), and a 21.7% stake in ViiV Healthcare (HIV joint venture with GSK, 78.3%), with commercial and R&D offices in the US, UK, Netherlands, China (Beijing and Shanghai), and Taiwan. Shionogi discovers, develops, manufactures, and commercializes small-molecule prescription pharmaceuticals with deep expertise in antibiotics since 1959, now extending into antivirals, rare diseases (ALS via RADICAVA, Pompe disease via S-606001), CNS/neuroscience, and HIV.

The company's technology platform is anchored by proprietary first-in-class small molecules, including cefiderocol (Fetroja/Fetcroja) — a siderophore cephalosporin antibiotic with novel iron-uptake mechanism against carbapenem-resistant Gram-negative bacteria — and olorofim, an oral antifungal representing the first new mechanism for invasive aspergillosis in over 20 years. Additional pipeline assets include ensitrelvir (Xocova), the first oral antiviral approved by FDA for COVID-19 post-exposure prophylaxis; anti-Nav1.7 antibodies for neuropathic pain; the PDE4D inhibitor S-898270 for memory formation; and the carbonic anhydrase inhibitor sulthiame for obstructive sleep apnea. The company holds FDA rare pediatric disease and orphan drug designations for S-606001 and a BARDA Project BioShield contract up to $482 million for US-based Fetroja manufacturing.

Shionogi's revenue model combines direct pharmaceutical product sales (RADICAVA, Fetroja, Xocova, ZURZUVAE), recurring royalty income from the ViiV Healthcare HIV franchise (Dovato holds leading European market share), milestone and licensing payments from collaborations (BioVersys up to CHF 479 million), and government/biodefense procurement (BARDA, HHS). Go-to-market operates through traditional pharmaceutical enterprise field sales via medical science liaisons targeting hospitals and specialists, channel partnerships including Torii Pharmaceutical (subsidiary) for Japan commercialization and ViiV Healthcare for global HIV distribution, and direct subsidiary commercial organizations in the US and Europe. The customer base spans hospital formularies, infectious disease specialists, neurologists, HIV specialists, individual ALS patients (22,000+ US patients on RADICAVA), and government health agencies. FY2023 IFRS net sales were JPY 435,081 million with operating income of JPY 153,310 million, placing Shionogi firmly in the multi-billion-dollar global pharmaceutical tier.

Name

Shionogi

Legal name

Shionogi & Co., Ltd.

Website

https://shionogi.com

Company type

Public

Founded year

1878

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Shionogi is a Japanese pharmaceutical company founded in 1878 that discovers, develops, and commercializes small-molecule drugs across infectious diseases, rare diseases (ALS, Pompe), HIV, and CNS therapeutics globally, operating through subsidiaries and a 21.7% stake in ViiV Healthcare.

Ownership category

akta.pro rank

Product category

Prescription Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Medical Equipment and Supplies Manufacturing (3391), Scientific Research and Development Services (5417)

SIC

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

akta.pro primary industry

Infectious Disease & Antimicrobials Pharmaceuticals (HLAIAAAG)

Keywords

• Prescription pharmaceuticals
• Antibiotic drug development
• Antiviral medications
• Rare disease therapeutics
• HIV treatment products

Headquarters

HQ city

Osaka-shi

HQ country

Japan

HQ region

Asia

Offices8 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: Direct sales of proprietary pharmaceutical products including antibiotics (Fetroja), antivirals (Xocova), ALS treatment (Radicava), and dermatology products through commercial organizations
2. HIV Royalties (ViiV Healthcare): Royalty income from ViiV Healthcare HIV products including Dovato (leading market share in Europe), with Shionogi holding 21.7% equity stake
3. Global Licensing Agreements: Licensing revenue from partnerships including BioVersys collaboration (up to CHF 479 million plus royalties for BV500 program) and technology out-licensing
4. Milestone Payments: Development and regulatory milestone payments from partnerships, including $50 million development milestone from SASS joint venture for sulthiame

Go-to-market motion3 records

Distribution channels5 records

Marketing channels5 records

Core offering

Shionogi is a pharmaceutical company that develops, manufactures, and commercializes prescription drugs across infectious diseases (antibiotics such as cefiderocol/Fetroja, antivirals including ensitrelvir/Xocova), rare diseases (RADICAVA/edaravone for ALS, S-606001 for Pompe disease), HIV (through its 21.7% stake in ViiV Healthcare and products such as Dovato), and CNS/neuroscience (ZURZUVAE for depression, S-898270 PDE4D inhibitor). The company also generates royalty income from licensing arrangements and pursues antimicrobial and rare disease therapies through partnerships with F2G, BioVersys, Apnimed, and others.

Product overview

Shionogi is a Japanese pharmaceutical company founded in 1878 that develops, manufactures, and sells prescription pharmaceuticals globally. The company's portfolio includes both marketed products and pipeline candidates across multiple therapeutic areas including infectious diseases (antibiotics, antivirals), rare diseases (ALS), HIV, and neuroscience. Key marketed products include Xocova (COVID-19 treatment), Fetroja (antibiotic), RADICAVA (ALS treatment acquired for $2.5B), Dovato (HIV, via ViiV Healthcare stake), ZURZUVAE (depression), and YCANTH (via Torii subsidiary). Pipeline candidates include S-606001 for Pompe disease in Phase 2, S-898270 for memory formation, and olorofim antifungal which completed Phase 3. Shionogi operates through subsidiaries including Shionogi Inc. (US), Shionogi B.V. (Europe), Qpex Biopharma (antimicrobial R&D), and holds stakes in ViiV Healthcare (21.7%, HIV) and Dioseve (fertility biotech).

Differentiator

Problem solved

Functional benefit

Products and services

• Xocova (ensitrelvir fumaric acid) Oral antiviral medication for COVID-19 treatment and post-exposure prevention. Received FDA approval as the first oral antiviral approved in the US for post-exposure prevention of COVID-19 in adults and children. Pediatric dosing expansion approved in Japan for children aged 6 to under 12.
• Fetroja/Fetcroja (cefiderocol) Antibiotic for treating serious Gram-negative bacterial infections including complex urinary tract infections, hospital-acquired bacterial pneumonia, and infections caused by carbapenem-resistant organisms. Approved for biothreat pathogen procurement under BARDA Project BioShield.
• RADICAVA (edaravone) ALS treatment acquired from Tanabe Pharma for $2.5 billion. Expected to contribute approximately $700 million in annual global sales. Used to treat over 22,000 ALS patients in the US. Includes oral (ORS) and intravenous formulations to slow physical decline in amyotrophic lateral sclerosis.
• ZURZUVAE (zuranolone) Capsules 30mg for treating major depressive disorder. Received regulatory approval in Japan in December 2025.
• Olorofim Novel oral antifungal developed with F2G for invasive aspergillosis. Phase 3 OASIS trial demonstrated non-inferiority to AmBisome with significantly fewer adverse events. First new mechanism of action for invasive aspergillosis in over 20 years.
• YCANTH Dermatology product for molluscum contagiosum treatment launched in Japan by Torii Pharmaceutical (Shionogi subsidiary) following MHLW approval.
• S-606001 (MZE001) Oral substrate reduction therapy for late-onset Pompe disease acquired from Maze Therapeutics in 2024. Enrolling patients in global Phase 2 Esprit trial as add-on to enzyme replacement therapy. Received FDA rare pediatric disease designation in 2025 and orphan drug designation in 2022.
• S-898270 Novel phosphodiesterase-4D (PDE4D) inhibitor for memory formation enhancement being studied in Phase 1 trial in Japan using Cumulus Neuroscience NeuLogiq Platform.
• S-002 (sulthiame) Carbonic anhydrase inhibitor for obstructive sleep apnea treatment. Part of Shionogi-Apnimed Sleep Science (SASS) joint venture, now wholly-owned by Shionogi. Development milestone payment of $50 million tied to this compound.
• BV500 Preclinical asset for non-tuberculous mycobacteria infections under global research collaboration with BioVersys, with potential milestone payments up to CHF 479 million plus royalties.
• Dovato (dolutegravir/lamivudine) HIV medication marketed through ViiV Healthcare (78.3% GSK, 21.7% Shionogi). Holds leading market share in Europe with growth plans for US and China. Shionogi receives royalty income from this HIV franchise.

Quantifiable outcome

• Cefiderocol demonstrated 23.8% mortality vs 24.3% for AmBisome in invasive aspergillosis Phase 3 OASIS trial
• +2 more outcomes

Named customers3 records

Segments6 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature6 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• F2GcoreStrategic or Co-development Partner · 18 June 2026F2G and Shionogi partnership for novel oral antifungal olorofim. Positive Phase 3 OASIS results demonstrated non-inferiority to AmBisome for invasive aspergillosis. F2G preparing US regulatory submission while Shionogi handles Europe/Asia submissions. First novel mechanism for this indication in 20+ years.
• BARDA (Biomedical Advanced Research and Development Authority)coreOthers · 9 April 2026$482 million BARDA Project BioShield contract ($119M initial funding, up to $363M additional) to establish US-based manufacturing facility for Fetroja antibiotic and support procurement for biothreat pathogens.
• Tanabe Pharma Corporation (Bain Capital)coreOthers · 1 April 2026$2.5 billion acquisition of global rights to RADICAVA (edaravone) and IV RADICAVA from Tanabe Pharma, establishing Shionogi's rare disease platform. Includes US commercial infrastructure and over 100 team members.
• FRONTEOminorStrategic or Co-development Partner · 25 March 2026FRONTEO and Shionogi jointly developed Talk Lab KIBIT conversational AI for brain health assessment as part of Asahi Life's 'Everyone's Assurance 100-Year Project.' Uses KIBIT NLP AI to analyze conversation patterns for cognitive indicators.
• ApnimedcoreStrategic or Co-development Partner · 24 March 2026Shionogi acquired Apnimed's 50% stake in Shionogi-Apnimed Sleep Science (SASS) joint venture for $150 million ($100M upfront + $50M milestone + royalties), making SASS wholly-owned. The joint venture focuses on sleep apnea treatments including sulthiame. Shionogi also previously expanded partnership with Apnimed to acquire shared IP rights for sulthiame as OSA treatment.
• Torii PharmaceuticalcoreChannel Partner/ Reseller/ Distributor · 9 February 2026Torii Pharmaceutical (Shionogi subsidiary) launched YCANTH in Japan for molluscum contagiosum following MHLW approval in September 2025. Ensures commercial access for dermatology product in Japan market.
• ViiV Healthcare (GSK, Pfizer)coreStrategic or Co-development Partner · 20 January 2026Shionogi increased stake in ViiV Healthcare to 21.7% (from 10%) for $2.125 billion as Pfizer exited. GSK retains 78.3%. ViiV focuses on HIV treatment and prevention with products including Dovato, Cabenuva, and long-acting injectables. Shionogi receives royalty income.
• Salubritas TherapeuticsminorStrategic or Co-development Partner · 24 December 2025Joint research and development agreement with Salubritas Therapeutics to demonstrate hearing function improvement through sensory hair cell regeneration, aiming to create innovative pharmaceuticals in hearing health.
• BioVersyscoreStrategic or Co-development Partner · 7 February 2025Global research collaboration and exclusive license option agreement with BioVersys for BV500 program targeting non-tuberculous mycobacteria infections. Potential milestone payments up to CHF 479 million plus royalties. Shionogi also co-sponsors Lifeline musical about AMR awareness.
• D-Wave QuantumminorOthers · 18 July 2024D-Wave cited Shionogi as evidence of practical quantum computing implementation alongside GE Vernova, E.ON, and Forschungszentrum Jülich in demonstrating annealing quantum computing viability.
• Qpex BiopharmacoreStrategic or Co-development Partner · 25 June 2023Shionogi acquired Qpex Biopharma, a private pharmaceutical company specializing in antimicrobial research, for $100M upfront with potential additional payments. The acquisition aimed to expand Shionogi's infectious disease pipeline and accelerate novel antibiotic development for AMR.
• Global Antibiotic Research and Development Partnership (GARDP)coreStrategic or Co-development Partner · 1 June 2023Partnership with GARDP and Clinton Health Access Initiative to expand global access to cefiderocol for severe Gram-negative bacterial infections, addressing antimicrobial resistance in low- and middle-income countries.

Scale indicators15 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Daiichi Sankyo: Japanese mid-cap pharma with similar revenue scale (~JPY 1.6T) and diversified therapeutic portfolio spanning oncology, infectious disease, and rare disease. Closely comparable in Japan-headquartered, mid-cap pharma with global commercial infrastructure.
• Astellas Pharma: Japanese pharma peer of similar size (~$25B market cap) with overlapping focus on infectious disease, oncology, and rare diseases (Xtandi, Padcev). Both companies share a similar Tokyo-headquartered, Japan-listed pharma business model with US/EU subsidiaries.
• Eisai: Japanese pharma of comparable scale with focus on neurology (Leqembi/Alzheimer's), oncology, and rare diseases. Similar global commercialization footprint and Japan-Tokyo listing; both compete in CNS/neuroscience and rare disease therapeutic areas.
• Sumitomo Pharma: Japanese mid-cap pharma with focus on CNS, infectious disease, and women's health. Comparable in size, therapeutic focus, and Japan-listed public company profile; both compete in similar therapeutic niches.

Broad incumbents

• GSK: Majority owner of ViiV Healthcare (78.3%) and partner to Shionogi in HIV. Operates broadly across pharma, vaccines, and specialty medicines; the ViiV partnership makes it a structurally relevant peer despite broader portfolio scope.
• Takeda Pharmaceutical: Largest Japanese pharma with global presence (~$50B market cap), significant rare disease and infectious disease focus post-Shire acquisition. Comparable in Japan-headquartered global pharma model, though materially larger.
• Merck & Co. Global pharma with leadership in infectious disease (antibiotics portfolio) and HIV research. Relevant comparable for Shionogi's infectious disease and HIV strategy, though materially larger and broader in scope.
• Pfizer: Former ViiV Healthcare partner (sold 11.7% stake to Shionogi for $2.125B). Comparable in infectious disease focus (Paxlovid competes with Xocova) and global pharma scale.
• AbbVie: Global pharma with significant neuroscience and specialty therapeutics focus. Relevant comparable for ZURZUVAE (zuranolone) partnership dynamics and broader CNS portfolio strategy.
• Bayer: Global pharma with established cardiovascular and specialty therapeutics portfolios. Comparable in diversified pharma model with European/Asian commercial reach; both share a similar global pharma operating structure.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/SHIONOGI_JP

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries8 records

Funding overview

Funding rounds3 records

Investors3 records

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M&A6 records

Investments12 records

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Frequently asked questions about Shionogi