GNI Japan

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.

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

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

• Anti-fibrotic therapeutics
• Orthobiologics products
• Pharmaceutical drug discovery
• Medical device manufacturing
• Clinical drug development

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. 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.
2. 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

Core 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

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature1 record

Partnerships

One partnership is on record.

• Shanghai JIUCE Medical Device Technology Co., Ltd.minorStrategic or Co-development PartnerShanghai 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

Direct 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

• Xx.com/GNIpharma
• YouTubeyoutube.com/@GNIpharma2160
• Instagraminstagram.com/gnipharma2160
• TikToktiktok.com/@gnipharma2160
• LinkedInlinkedin.com/company/gni-group-ltd

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries9 records

Funding overview

Funding rounds

Investors

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

M&A

Investments4 records

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

Frequently asked questions about GNI Japan