YD Bio

What YD Bio does

YD Bio Limited (Nasdaq: YDES) is a Taiwan-headquartered, Nasdaq-listed biotechnology company that operates across three integrated business lines: DNA methylation-based early cancer detection diagnostics, exosome-based ophthalmology therapeutics, and pharmaceutical clinical trial supply and regulatory services. The company's diagnostic platform, branded OkaiDx, uses cfDNA methylation analysis of blood samples to detect pancreatic, breast, and colorectal cancers with high reported sensitivity and specificity, and is delivered through a CAP/CLIA-certified laboratory in Bothell, Washington, as well as via the EG Telehealth Platform covering 44 U.S. states, Washington D.C., and Guam. Its ophthalmology franchise is built on licensed corneal mesenchymal stem cell and exosome technology, with the Exovisse contact lenses and artificial tears receiving FDA clearance in November 2025. The company also serves as a clinical trial drug and ancillary product supplier to global pharmaceutical companies, with a long-standing Novartis relationship dating to 2015, and has positioned a new 'Taiwan-U.S. Dual-Core' regulatory platform to act as exclusive U.S. Agent and FDA liaison for Asian CRO clients.

The company generates revenue through a mix of pharmaceutical product sales (including branded clinical trial drugs such as Keytruda and ancillary products), laboratory-developed test fees, licensing royalties (including a 20% royalty paid to EG BioMed on breast cancer detection revenues), and emerging clinical trial and regulatory services revenue. In FY2025, YD Bio reported net revenue of $596,817, a 17% year-over-year increase, with growth driven by pharmaceutical product sales and new product launches. The company became publicly traded in August 2025 via a SPAC business combination with Breeze Holdings Acquisition Corp., raising approximately $11.5-13.2 million in PIPE proceeds at a ~$715 million post-money valuation. YD Bio is pursuing an aggressive transformation strategy that includes a proposed merger with EG BioMed, a binding LOI to acquire Safe Save Medical Cell Sciences & Technology (SSMC) for approximately US$26.87 million, and multiple FDA regulatory milestones including a first IND filing for dendritic cell immunotherapy targeting glioblastoma.

Name

YD Bio

Legal name

YD Bio Limited

Website

https://ir.ydesgroup.com

Company type

Public

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

YD Bio Limited is a Taiwan-based, Nasdaq-listed biotechnology company developing DNA methylation-based blood tests for early cancer detection (OkaiDx), FDA-cleared exosome-based ophthalmology products (Exovisse), and clinical trial drug supply and FDA regulatory liaison services for pharmaceutical and Asian CRO clients.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals and Cancer Diagnostics

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)

akta.pro secondary industries

Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics) (HLAAALAD), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD)

Keywords

• DNA methylation diagnostics
• Cancer detection tests
• Regenerative ophthalmology
• Clinical trial supply
• Biopharmaceutical products

Headquarters

HQ city

Bothell

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: Revenue from sales of pharmaceutical products including Keytruda injection, contact lenses, and other medical drugs. The company serves as a supplier of clinical trial drugs and post-launch ancillary products to pharmaceutical companies.
2. Laboratory-Developed Tests (LDTs): Revenue from cancer detection diagnostic services including pancreatic cancer screening and breast cancer monitoring tests offered as LDTs through CLIA-certified laboratory networks.
3. Licensing Royalties: Revenue from exclusive licensing agreements with partners including 20% revenue royalty to EG BioMed for breast cancer detection technology, with 20-year terms and automatic 5-year renewals.
4. Clinical Trial Services: Revenue from supplying investigational drugs and ancillary materials to global pharmaceutical companies conducting clinical development programs.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels3 records

Core offering

YD Bio is a clinical-stage biotechnology company that develops and commercializes DNA methylation-based blood diagnostic tests for early cancer detection (pancreatic, breast, colorectal, liver, gastrointestinal cancers) and exosome-based ophthalmology products including FDA-cleared contact lenses and artificial tears. The company also supplies investigational drugs and ancillary materials to global pharmaceutical companies for clinical trials, and is expanding into FDA regulatory liaison services for Asian biotech clients through its Taiwan-U.S. Dual-Core platform.

Differentiator

Problem solved

Functional benefit

Brands

• OkaiDx: Blood-based cancer detection platform using cfDNA methylation technology for early cancer detection including pancreatic, colorectal, liver, gastrointestinal, and breast cancers
• Exovisse
• EG Telehealth Platform

Products and services

• OkaiDx Cancer Detection Tests Laboratory-developed tests (LDTs) using cfDNA methylation analysis of blood samples to enable early detection of pancreatic, breast, colorectal, liver, and gastrointestinal cancers, as well as post-treatment cancer recurrence monitoring. Tests are processed through EG BioMed's CLIA/CAP-certified laboratory in Bothell, Washington, and offered to healthcare providers and patients.
• Exovisse Contact Lenses and Artificial Tears FDA-cleared exosome-based contact lenses and artificial tears for the treatment of dry eye disease and related ophthalmologic conditions, leveraging exosome technology derived from corneal mesenchymal stem cells. Distributed through pharmacies and optometrists in the U.S. market.
• EG Telehealth Platform Telehealth-based nationwide cancer detection and decentralized clinical services platform enabling patient access to early cancer screening and post-treatment monitoring through licensed physicians across 44 U.S. states, Washington D.C., and Guam. Powered by EG BioMed's CAP-accredited laboratory in Bothell, Washington.
• Clinical Trial Drug Supply Services Supply of investigational drugs and ancillary materials to global pharmaceutical companies conducting clinical development programs, anchored by a long-standing supplier relationship with Novartis dating back to 2015. Services include clinical testing drug supply and post-launch ancillary product supply for pharmaceutical development and commercialization.
• FDA Regulatory Liaison and U.S. Agent Services Regulatory affairs and FDA liaison services covering IND, NDA, BLA, 510(k), and PMA filings for Asian biotech and CRO clients seeking U.S. market entry, delivered through YD Bio USA, Inc. as the exclusive U.S. Agent under the Taiwan-U.S. Dual-Core regulatory platform.
• Dendritic Cell Immunotherapy Programs (Glioblastoma) Late-stage dendritic cell immunotherapy programs targeting glioblastoma, leveraging proprietary protocols for immune cell expansion and cell engineering. First FDA IND filing completed, with conditional clinical pathway milestone targeted in Taiwan by 2027.
• Limbal Stem Cell Platform Limbal stem cell platform for ophthalmology indications including dry eye disease treatment, leveraging patented corneal mesenchymal stem cell and exosome technology licensed from 3D Global Biotech Inc. Drug Master Files filed with FDA.

Quantifiable outcome

• High sensitivity and specificity for pancreatic cancer early detection using OkaiDx test
• +2 more outcomes

Named customers3 records

Segments4 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

Feature4 records

Partnerships

Five partnerships are on record, tiered core and minor.

• YC Biotech Co., Ltd.coreStrategic or Co-development Partner · 24 February 2026Master Strategic Alliance Agreement establishing YD Bio USA as exclusive U.S. Agent and FDA liaison for YC Biotech's Asian CRO clients, creating a 'Taiwan-U.S. Dual-Core' regulatory platform covering IND, NDA, BLA, 510(k), and PMA filings. The partnership shifts YD Bio's business model from single-project advisory to a scalable platform with potential expansion to EMA.
• Safe Save Medical Cell Sciences & Technology (SSMC)minorStrategic or Co-development Partner · 20 January 2026Binding Letter of Intent to acquire all shares, assets, and business operations of SSMC for approximately US$26.87 million (NT$839,832,000). The acquisition intends to integrate SSMC's advanced immunocell therapy capabilities into YD Bio's portfolio as part of strategic transformation into an end-to-end biotechnology ecosystem.
• EG BioMedcoreStrategic or Co-development Partner · 6 January 2026Non-binding Memorandum of Understanding to merge with EG BioMed, a biotechnology company specializing in DNA methylation-based cancer diagnostics and AI-driven biomarker analytics. The proposed merger aims to create an integrated oncology platform combining diagnostics, real-world clinical data, and AI-enabled drug discovery, with closing anticipated in 2026 subject to regulatory approvals.
• 3D Global Biotech Inc.coreOEM/ Whitelabel/ Licensing PartnerLicensing partnership for corneal mesenchymal stem cells and exosome technologies for treating eye disorders. YD Bio obtained patent and technology authorization to develop treatments for dry eye disease, glaucoma, and corneal repair, with clinical development efforts underway including IRB-approved specimen collection.
• Breeze Holdings Acquisition Corp.coreStrategic or Co-development PartnerCompleted business combination in August 2025 making YD Bio a publicly traded company on Nasdaq Global Market under ticker YDES. The transaction raised over $11.5 million to fund operations and accelerate development of cancer detection and ophthalmologic therapies.

Scale indicators7 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• GRAIL: GRAIL develops blood-based methylation-based multi-cancer early detection tests (e.g., Galleri), directly competing with YD Bio's OkaiDx methylation platform in the same cfDNA methylation cancer detection category.
• Guardant Health: Guardant Health offers blood-based cancer detection and monitoring using cfDNA analysis (Guardant360, Shield), overlapping with YD Bio's methylation-based liquid biopsy LDTs for cancer detection and recurrence monitoring.
• Exact Sciences: Exact Sciences markets Cologuard and Oncotype DX, molecular diagnostics for cancer screening and recurrence monitoring, addressing the same early detection and post-treatment monitoring use cases as YD Bio's OkaiDx platform.
• Natera: Natera develops cell-free DNA tests including Signatera for molecular residual disease and recurrence monitoring in oncology, directly comparable to YD Bio's cfDNA methylation-based breast cancer monitoring test.
• Personalis: Personalis provides genomic-based molecular diagnostics for cancer, including tumor-informed ctDNA assays, competing with YD Bio's methylation-based cancer detection and monitoring LDTs.
• Caris Life Sciences: Caris offers molecular profiling and AI-driven biomarker analytics across cancer types, comparable to YD Bio's planned integration with EG BioMed's AI biomarker platform for methylation-based oncology diagnostics.

Emerging players

• Freenome: Freenome is an emerging blood-based multi-cancer screening company using cfDNA methylation and other multiomics signals, pursuing the same early detection market YD Bio targets with OkaiDx but with a broader multi-cancer pipeline.
• Adaptive Biotechnologies: Adaptive Biotechnologies combines immune cell receptor sequencing with diagnostic and therapeutic applications including oncology, overlapping with YD Bio's dendritic cell immunotherapy and oncology diagnostics strategy.

Broad incumbents

• NeoGenomics: NeoGenomics is a large oncology-focused clinical laboratory providing molecular and genetic testing services, comparable to YD Bio as a molecular diagnostics lab serving healthcare providers, though at much greater scale.

Regional players

• Burning Rock Biotech: Burning Rock is a China-based cancer genomics company providing NGS-based cancer detection and monitoring tests, comparable to YD Bio's methylation cancer detection platform but focused on the Chinese market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/YD_Bio_Limited
• LinkedInlinkedin.com/company/yd-bio

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries2 records

Funding overview

Funding rounds1 record

Investors

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

M&A2 records

Investments

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

Frequently asked questions about YD Bio