GNI Japan
GNI Japan is a Tokyo-headquartered, TSE Growth-listed global healthcare group that develops and commercializes Pirfenidone (Etuary) for fibrotic diseases in China and orthobiologics products in the US and Japan through subsidiaries including Berkeley Advanced Biomaterials.
- Company typePublic
- Founded2001
- HeadquartersTokyo, Japan
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What GNI Japan does
The medical device (medtech) segment is anchored by US-based Berkeley Advanced Biomaterials LLC and Berkeley Biologics LLC, which manufacture and sell orthobiologics products including H-GENIN DBM Crush Mix (demineralized bone matrix), AltiPly (amnion allograft), and Cem-Ostetic (synthetic bone powder) for orthopedic tissue repair, bone defect filling, and wound healing. The group maintains a 30% equity-method affiliate in Shanghai JIUCE Medical Device Technology Co., Ltd., which produces proprietary supporting tools compatible with Berkeley products. As of December 2025, the consolidated group employed 990 people and reported paid-in capital of ¥19,855 million; pricing on individual products is not publicly disclosed and revenue figures are not publicly disclosed in available materials. The go-to-market model is enterprise field sales targeting medical institutions and healthcare providers across each operating geography.
GNI Japan firmographics
Firmographics- Name
- GNI Japan
- Legal name
- 株式会社ジーエヌアイグループ
- Website
- https://gnipharma.com
- Company type
- Public
- Founded year
- 2001
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- GNI Japan is a Tokyo-headquartered, TSE Growth-listed global healthcare group that develops and commercializes Pirfenidone (Etuary) for fibrotic diseases in China and orthobiologics products in the US and Japan through subsidiaries including Berkeley Advanced Biomaterials.
- Ownership category
- akta.pro rank
GNI Japan industry classification
Industry- Product category
- Pharmaceuticals and Medical Devices (Orthobiologics)
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Surgical Appliance and Supplies Manufacturing (339113)
- SIC
- Pharmaceutical Preparations (2834), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)
- akta.pro primary industry
- Respiratory & Allergy Pharmaceuticals (HLAIAAAH)
Keywords
Where GNI Japan is headquartered
LocationHeadquarters
- HQ city
- Tokyo
- HQ country
- Japan
- HQ region
- Asia
Offices4 records
Markets served
GNI Japan business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain
Revenue model
- Pharmaceutical Sales: Sales of approved drugs including Etuary (Pirfenidone) for idiopathic pulmonary fibrosis (IPF), generated in China market with expansion to other indications including radiation pneumonitis, interstitial lung disease with connective tissue disease, and diabetic nephropathy.
- Medtech/Medical Device Sales: Sales of orthobiologics products including H-GENIN DBM Crush Mix (demineralized bone matrix), AltiPly amniotic allograft, Cem-Ostetic artificial bone powder, and supporting tools for medical procedures. Operations through US subsidiaries Berkeley Advanced Biomaterials LLC and Berkeley Biologics LLC.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
GNI Japan product offering
Product offeringCore offering
GNI Japan is a global healthcare company that develops, manufactures, and sells pharmaceutical products (primarily Pirfenidone/Etuary for idiopathic pulmonary fibrosis) and orthobiologics medical devices (demineralized bone matrix, amnion allografts, synthetic bone powder) through consolidated subsidiaries in Japan, China, the United States, and Australia. The company combines a proprietary AI-powered drug discovery platform with cost-efficient China-based clinical development to address unmet medical needs for fibrotic diseases and orthopedic tissue repair.
Product overview
GNI Japan operates two main business segments: a Pharmaceutical Business focused on Pirfenidone (Etuary/アイスーリュイ), an antifibrotic drug for IPF and other fibrotic diseases, and a Medtech Business (Medical Device Business) offering orthobiologics products including H-GENIN DBM クラッシュミックス, AltiPly amnion allograft, and Cem-Ostetic synthetic bone powder through its US subsidiary Berkeley Advanced Biomaterials LLC. The pharmaceutical segment also includes supporting tools and services for clinical use.
Differentiator
Problem solved
Functional benefit
Brands
- Etuary (アイスーリュイ / 艾思瑞): Pirfenidone product for Idiopathic Pulmonary Fibrosis (IPF) treatment in China
- H-GENIN DBM Crush Mix
- AltiPly
- Cem-Ostetic
Products and services
- Pirfenidone / Etuary (アイスーリュイ) Antifibrotic, anti-inflammatory, and antioxidant treatment drug for idiopathic pulmonary fibrosis (IPF). Approved in China in September 2011, with manufacturing approval in December 2013 and commercial launch in February 2014. Also being developed for radiation pneumonitis, interstitial lung disease with connective tissue disease, and diabetic nephropathy. Targeted at healthcare providers treating patients with fibrotic diseases.
- H-GENIN DBM クラッシュミックス (H-GENIN DBM Crush Mix) Demineralized bone matrix (DBM) product used to fill defects or voids not directly related to bone structural stability. Suitable for bone defects from surgical procedures or trauma, including use as bone defect filling material during posterolateral fusion procedures. For medical institutions and orthopedic surgeons performing bone repair.
- AltiPly 羊膜同種移植片 (AltiPly Amnion Allograft) Next-generation freeze-dried amnion allograft that supports wound healing for both acute and chronic wounds. Retains growth factors necessary for wound healing through proprietary processing technology, with basement membrane and epithelial layer providing natural barrier protection. For medical institutions and surgical centers performing wound healing and dermatological procedures.
- Cem-Ostetic (人工骨パウダー / Synthetic Bone Powder) Synthetic bone powder manufactured and sold by Berkeley Advanced Biomaterials LLC (BAB), part of the orthobiologics product portfolio for orthopedic tissue repair and regeneration. Targeted at medical institutions and orthopedic surgeons performing bone repair procedures.
Quantifiable outcome
- Etuary (Pirfenidone) approved in China September 2011, manufacturing license December 2013, sales started February 2014
Companies that use GNI Japan
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles2 records
GNI Japan technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability1 record
Feature1 record
GNI Japan partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Shanghai JIUCE Medical Device Technology Co., Ltd.minorShanghai JIUCE Medical Device Technology Co., Ltd. is an equity method affiliate (持分法適用会社) in which GNI Group holds 30% equity stake. The company developed proprietary supporting tools that work with BAB products, enabling safer and more efficient medical procedures.
Scale indicators3 records
Recent moves6 records
Expansion highlights5 records
GNI Japan competitors and assessment
Company assessmentDirect peers
- FibroGen: FibroGen develops therapeutics targeting fibrotic disease including IPF (pamrevlumab). Comparable as a specialty biotech focused on the same antifibrotic therapeutic space as GNI.
- Boehringer Ingelheim: Boehringer Ingelheim sells Ofev (nintedanib), the other approved antifibrotic for IPF. Head-to-head competitor to Etuary in IPF and adjacent fibrotic indications.
- United Therapeutics: United Therapeutics markets Tyvaso for pulmonary hypertension and PH-ILD, with strong IPF-adjacent commercial infrastructure. Comparable specialty pulmonary pharma with overlapping physician call points.
- Roche: Roche markets Esbriet (pirfenidone), the originator brand for IPF and a direct competitor to GNI's Etuary. Most directly comparable on therapeutic area, mechanism, and indication overlap.
Broad incumbents
- Zimmer Biomet: Zimmer Biomet offers an orthobiologics line including bone substitutes and regenerative products. Comparable broad incumbent competing in the same orthopedic purchasing channels as GNI's Berkeley subsidiaries.
- Stryker: Stryker's Orthopaedics and Spine division sells bone graft substitutes, DBM products and regenerative tissue products that compete head-to-head with H-GENIN and AltiPly in the US hospital channel.
- Medtronic: Medtronic operates a broad orthobiologics and spine portfolio that directly overlaps GNI's Berkeley Advanced Biomaterials orthobiologics franchise. Comparable as a large incumbent in the same procedural channels.
Regional players
- Shanghai Pharmaceuticals Holding: Shanghai Pharmaceuticals is a major China-based pharma group with manufacturing and distribution scale. Comparable as a Chinese pharma platform providing context for GNI's China-centric pharma and medtech footprint.
- Jiangsu Hengrui Pharmaceuticals: Hengrui is China's largest domestic innovative pharma company with integrated discovery-to-commercial capabilities. Comparable as a China-based integrated pharma with cost-efficient operations in overlapping therapeutic categories.
- Shionogi: Shionogi is a Japan-listed mid-cap pharma with global ambitions, comparable to GNI as a Japanese-headquartered specialty pharma group pursuing cross-border drug development and commercialization.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
GNI Japan social profiles
Digital presenceGNI Japan compliance and trust
Trust signalCompliance1 record
GNI Japan financial estimates
Financial estimateRevenue estimate
Valuation estimate
GNI Japan leadership team
Management profileNumber of profiles
Profiles7 records
GNI Japan subsidiaries and ownership
Company hierarchySubsidiaries9 records
GNI Japan funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
GNI Japan M&A and investment
M&A and investmentM&A
Investments4 records
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about GNI Japan
What does GNI Japan do?
GNI Japan is a global healthcare company that develops, manufactures, and sells pharmaceutical products (primarily Pirfenidone/Etuary for idiopathic pulmonary fibrosis) and orthobiologics medical devices (demineralized bone matrix, amnion allografts, synthetic bone powder) through consolidated subsidiaries in Japan, China, the United States, and Australia. The company combines a proprietary AI-powered drug discovery platform with cost-efficient China-based clinical development to address unmet medical needs for fibrotic diseases and orthopedic tissue repair.
Is GNI Japan a public or private company?
GNI Japan is a public company. It is classified as public and is currently operating.
When was GNI Japan founded?
GNI Japan was founded in 2001. It employs 1 to 10 people.
Where is GNI Japan based?
GNI Japan is headquartered in Tokyo, Japan, in the Asia region.
How does GNI Japan make money?
Two revenue lines are on record. Pharmaceutical Sales are the primary driver. The others are medtech/Medical Device Sales.
Who are GNI Japan's main competitors?
Direct peers on record are FibroGen, Boehringer Ingelheim, United Therapeutics and Roche. Broad incumbents are Zimmer Biomet, Stryker and Medtronic. Regional players are Shanghai Pharmaceuticals Holding, Jiangsu Hengrui Pharmaceuticals and Shionogi.
Does GNI Japan have an API?
No public API is recorded for GNI Japan.
What industry is GNI Japan in?
GNI Japan's product category is Pharmaceuticals and Medical Devices (Orthobiologics). Its primary akta.pro industry code is HLAIAAAH, Respiratory & Allergy Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.