YD Bio Limited to Broaden U.S. Footprint with Planned California Operations Hub and Facilities

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Taipei, Taiwan, Dec. 16, 2025 — YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology firm developing DNA methylation-based cancer detection and ophthalmologic innovations, has unveiled plans to establish new facilities and a U.S. operations center in California. This initiative aims to speed up clinical development, regulatory interactions, and commercial availability for its next-generation diagnostics and exosome-based therapeutics.

The location for the California operations center is currently under review, with the final city yet to be determined. The center is designed to bolster clinical collaboration, regulatory planning, and expanded operational capacity. This is expected to help achieve quicker clinical validation, more streamlined regulatory filings, and broader U.S. patient access to non-invasive cancer tests and advanced diagnostic services.

Dr. Ethan Shen, Chairman and CEO, stated that this expansion demonstrates YD Bio’s dedication to turning scientific innovation into patient benefits and generating high-quality local jobs. “The Company will hire scientific, regulatory, and operational personnel and will launch the site in stages. This process will start with choosing a location and building a team, followed by the gradual activation of laboratory, manufacturing support, and commercial operations to ensure a smooth and compliant transition to full functionality.”

The Company will run the California center based on four strategic pillars:

1) Clinical & Regulatory Frontline

  • Main point of contact for FDA communications, including pre‑IND/IDE meetings
  • Assistance with clinical trial design, IRB coordination, and linkage with U.S. healthcare systems
  • Minimizing delays from time zones and regulatory processes to speed up data collection

2) Market Access & Commercial Readiness

  • Forging partnerships with U.S. healthcare providers, key opinion leaders (KOLs), and industry partners
  • Educating the market and establishing early positioning for diagnostics, exosome initiatives, and cell therapies
  • Facilitating B2B licensing agreements, collaborations, and strategic investment efforts

3) Manufacturing & Supply Chain Interface

  • Coordination with 3D Global Biotech’s investments in U.S. GMP manufacturing
  • Central hub for managing future company-owned or acquired GMP facilities
  • Connecting with U.S. CDMOs and creating scalable systems for quality control, production, and logistics

4) Talent & Operations Hub

  • Hiring U.S.-based experts in regulatory affairs, clinical operations, and commercial functions
  • Providing support for YD Bio’s worldwide research, development, and commercialization projects
  • Gradual launch to carefully control expenses and mitigate risks

3D Global Biotech’s New GMP Plant

YD Bio considers the California center a strategic asset to help reduce development cycles and increase patient availability of less invasive diagnostics and therapies. The center is anticipated to enable faster clinical validation, simplify pre-submission regulatory discussions, and improve preparedness for future commercial launches.

This move aligns with YD Bio’s wider regional progress in cross-border biomanufacturing and cell therapy investment. The Company’s partner, 3D Global Biotech Inc., recently revealed a NT$210 million ($6.72 million) investment to construct a GMP (Good Manufacturing Practice) cell therapy production facility in the U.S. This highlights increasing sector focus on creating local manufacturing and regulatory bases to advance clinical and commercial goals. YD Bio plans to synchronize its California operations center with this GMP project to improve integrated coordination throughout development, quality assurance, and supply chain operations.

About YD Bio Limited

YD Bio Limited is a biotechnology company dedicated to progressing clinical trials, novel drug development, cancer prevention diagnostics, and limbal stem cell and exosome therapies that could revolutionize care for diseases with significant unmet needs. The Company aims to enhance patient outcomes via scientific innovation and precision medicine. Beyond its research and development, YD Bio Limited is an established supplier of clinical trial medications and has grown its business to include creating and distributing post-market auxiliary products. For further details, visit the Company’s website:

Forward-Looking Statements

This announcement contains forward-looking statements regarding, among other things, YD Bio’s business strategy and prospects. These statements involve known and unknown risks and uncertainties and are founded on the Company’s present assumptions and forecasts about future events that may impact its financial position, operational results, strategic direction, and capital requirements. Investors can recognize these statements by terms like “approximately,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may,” or comparable phrasing. YD Bio does not commit to publicly updating or revising any forward-looking statements to account for new events, changing circumstances, or revised expectations, except where legally mandated. While YD Bio considers the expectations in these statements reasonable, it cannot guarantee their accuracy and warns investors that actual outcomes may vary substantially from projections. Investors are encouraged to examine additional factors that could influence future performance in YD Bio’s registration statement and other reports filed with the U.S. Securities and Exchange Commission.

For investor and media inquiries, please contact:

YD Bio Limited
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Phone: +1 628 283 9214