Taipei, Taiwan, Dec. 16, 2025 (GLOBE NEWSWIRE) -- YD Bio Limited ("YD Bio" or the "Company") (NASDAQ:YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced initiation of its latest plans for new facilities and a U.S. operations center in California to accelerate clinical development, regulatory engagement and commercial access for next‑generation diagnostics and exosome‑based therapeutics.

The California operations center is currently in the site evaluation phase and the specific host city has not yet been finalized. It will support clinical collaboration, regulatory strategy and scaled operational capabilities, which is intended to assist with enabling faster clinical validation, more efficient regulatory submissions and improved access to non‑invasive cancer tests and advanced diagnostic services across the United States.

The expansion reflects YD Bio's commitment to translating innovative science into patient benefit while creating high‑quality local employment, Dr. Ethan Shen, Chairman and CEO of the Company, commented. "The Company will recruit scientific, regulatory and operational talent and will activate the site in phases, beginning with site selection and staffing, followed by staged commissioning of laboratory, manufacturing support and commercial functions to ensure a compliant and efficient ramp to full operations."

The Company will operate the California center through four strategic pillars:

1) Clinical & Regulatory Frontline

Primary interface for FDA engagement, including pre‑IND/IDE interactions
Support for clinical trial design, IRB coordination, and integration with U.S. health systems
Reduction of time‑zone and regulatory friction to accelerate evidence generation

2) Market Access & Commercial Readiness

Development of partnerships with U.S. providers, key opinion leaders (KOLs), and industry stakeholders
Market education and early positioning for diagnostics, exosome programs, and cell therapies
Enablement of B2B licensing, collaborations, and strategic investment initiatives

3) Manufacturing & Supply Chain Interface

Alignment with 3D Global Biotech's U.S. GMP manufacturing investments
Central operations hub for prospective owned or acquired GMP facilities
Integration with U.S. CDMOs and establishment of scalable quality, production, and logistics pathways

4) Talent & Operations Hub

Recruitment of U.S.-based regulatory, clinical, operations, and commercial talent
Support for YD Bio's global R&D and commercialization activities
Phased activation to prudently manage cost and risk

3D Global Biotech's New GMP Plant

YD Bio views the California center as a strategic enabler supporting efforts to shorten development timelines and expand patient access to less invasive diagnostic tools and therapeutic programs. It is expected to facilitate accelerated clinical validation, streamline pre‑submission interactions and enhance readiness for future commercialization activities.

The plan is also consistent with YD Bio's broader regional momentum in cross‑border biomanufacturing and cell therapy investment. The Company's partner 3D Global Biotech Inc. recently announced a NT$210 million ($6.72 million) investment to build a GMP (Good Manufacturing Practice) cell therapy manufacturing plant in the U.S., underscoring growing industry interest in establishing local manufacturing and regulatory footholds to support clinical and commercial ambitions. YD Bio intends to align its California operations center with this GMP build‑out to strengthen end‑to‑end coordination across development, quality and supply chain functions.

About YD Bio Limited

YD Bio Limited is a biotechnology company focused on advancing clinical trials, new drug development, cancer prevention diagnostics, and limbal stem cell and exosome therapies with the potential to transform the treatment of diseases with high unmet medical need. The Company is committed to improving patient outcomes through scientific innovation and precision medicine. In addition to its R&D efforts, YD Bio Limited is a recognized supplier of clinical trial drugs and has expanded into the development and distribution of post-market auxiliary products. For more information, please visit the Company's website: ir.ydesgroup.com

Forward-Looking Statements

Certain statements in this announcement are forward-looking statements, including, but not limited to, YD Bio's business plan and outlook. These forward-looking statements involve known and unknown risks and uncertainties and are based on YD Bio's current expectations and projections about future events that YD Bio believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as "approximates," "believes," "hopes," "expects," "anticipates," "estimates," "projects," "intends," "plans," "will," "would," "should," "could," "may" or other similar expressions. YD Bio undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although YD Bio believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and YD Bio cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in YD Bio's registration statement and other filings with the U.S. Securities and Exchange Commission.

For investor and media inquiries, please contact:

YD Bio Limited

Investor Relations

Email: investor@ydesgroup.com

WFS Investor Relations Inc.

Email: services@wealthfsllc.com

Phone: +1 628 283 9214

YD Bio Limited Expands U.S. Presence with Newly Planned California Facilities and Operations Center