YD Bio Limited Announces Major Milestones and Unveils Robust 2026 Clinical and Commercial Roadmap

Taipei, Taiwan, Jan. 05, 2026 (GLOBE NEWSWIRE) -- YD Bio Limited (Nasdaq: YDES), a biotechnology company focused on advancing DNA methylation-based cancer detection technology and ophthalmic innovations, has reported significant progress across its core platforms. The company has announced the successful completion of critical milestones in its stem cell therapy and exosome platforms aimed at improving ophthalmological conditions, as well as early cancer detection through next-generation precision diagnostics. Furthermore, YD Bio has articulated a catalyst-driven plan for 2026, transitioning from platform validation to accelerated clinical and commercial development, contingent upon regulatory feedback and available resources.

“2025 has been a transformative year for YD Bio, as we've systematically de-risked our foundational platforms and strategically positioned ourselves for rapid advancement,” stated Dr. Ethan Shen, Chairman and CEO. The company has reached critical Chemistry, Manufacturing, and Controls (CMC) milestones and submitted Drug Master Files (DMFs) to facilitate future regulatory submissions.

Clinical Development Accelerates Across Global Platforms

YD Bio has completed comprehensive CMC development for its Limbal Stem Cell (LSC) platform and LSC-derived exosome products. Key achievements include successful batch testing, qualification of primary LSC cell sources, and the establishment of scalable cell expansion and cryopreservation methods. These advancements are paired with robust exosome expansion, purification, and potency assay methods that ensure readiness for Investigational New Drug (IND) applications.

• FDA Approval: Currently, the FDA has not approved any products from YD Bio.
• Regulatory Framework: The filed DMFs establish a reusable framework aimed at reducing program risk and streamlining future IND filings.

Advancing Ophthalmology Programs in the United States

YD BioMed plans to advance two major ophthalmology programs utilizing its LSC Exosome platform, with regulatory and clinical milestones yet to be confirmed:

• Dry Eye Disease (DED):
  • Expected in 2026: Establishment of a clinical-grade LSC cell bank and IND submission.
  • Expected in 2027: Initiation of a Phase I clinical trial.
• Age-Related Macular Degeneration (AMD):
  • Expected in 2026: Completion of preliminary preclinical studies and IND submission.
  • Expected in 2027: Entry into first-in-human clinical trials.

Expansion of Precision Oncology Diagnostics

Through its affiliate EG BioMed, YD Bio operates CLIA- and CAP-certified laboratory services across 46 U.S. states, offering Laboratory Developed Tests (LDTs) for early detection and monitoring of several cancers. The company aims to enhance its registration efforts in states such as Maryland and New Jersey in 2026.

The flagship OkaiDx™ pancreatic cancer early detection program is progressing through an FDA-aligned clinical validation pathway, with key milestones expected throughout 2026, including:

• Completion of patient enrollment.
• Data cleaning and preliminary statistical analysis.
• FDA Q-Submission to discuss potential Breakthrough Device eligibility.

Strengthening Intellectual Property and Scientific Leadership

YD Bio has significantly bolstered its global intellectual property portfolio, issuing breast cancer patents in 28 countries and pancreatic cancer IP in the United States. Additional approvals are anticipated in Europe and Asia in 2026. This positions the company for long-term licensing and growth opportunities.

Strategic Acquisitions for Growth

The company is exploring up to three strategic acquisitions in 2026 designed to enhance precision medicine capabilities. These acquisitions aim to integrate advanced diagnostic and analytical tools that will support ongoing detection, stratification, therapy, and monitoring efforts.

In conclusion, YD Bio Limited (YDES) is setting the foundation for significant growth and development in both the oncology and ophthalmology fields. With an ambitious roadmap and multiple milestones expected over the coming years, the company is poised for accelerated advancements and potential market impacts in the biotechnology sector.