YD Bio Limited Announces Strategic Partnership with YC Biotech Co., Ltd. to Establish a Taiwan-U.S. Dual-Core Regulatory Platform

YD Bio (Nasdaq: YDES) announced on Feb 25, 2026 a Master Strategic Alliance Agreement dated Feb 24, 2026 with YC Biotech to create a "Taiwan-U.S. Dual-Core" regulatory platform.

Rhea-AI Summary

YD Bio (Nasdaq: YDES) announced on Feb 25, 2026 a Master Strategic Alliance Agreement dated Feb 24, 2026 with YC Biotech to create a "Taiwan-U.S. Dual-Core" regulatory platform.

YD Bio USA will serve as YC Biotech's exclusive U.S. Agent for FDA interactions and coordinate IND, NDA, BLA and device filings, while YC Biotech leads project execution and submission drafting.

Positive

• Exclusive U.S. Agent role for YD Bio USA to liaise with FDA on behalf of YC Biotech clients
• Coverage of major filings including IND, NDA, BLA, IDE, 510(k), De Novo and PMA submissions
• Scalable platform strategy shifting company model from single-project advisory to recurring cross-border regulatory services
• Integrated execution combining YC Biotech's Asian CRO capabilities with YD Bio USA's U.S. regulatory experience

Negative

• None.

Argus Feb 25 session

+4.53% close to close Open Argus

Details

News Market Reaction – YDES

In the Feb 25 session, YDES gained 4.53%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds a Taiwan–U.S. dual-core regulatory platform to YD Bio’s prior moves in acquis...

Analysis

This announcement adds a Taiwan–U.S. dual-core regulatory platform to YD Bio’s prior moves in acquisitions, clinical roadmap expansion, and U.S. infrastructure build-out. The Agreement positions YD Bio USA as an exclusive U.S. FDA liaison for Asian CRO clients across IND, NDA, BLA, IDE, 510(k), De Novo, and PMA pathways. In context of recent 424B3 and F-1/A filings and governance changes, investors may watch how effectively this alliance converts into recurring projects and integrates with the broader biotechnology ecosystem strategy.

Key Figures

Agreement date: February 24, 2026 Announcement date: February 25, 2026

Agreement date

February 24, 2026

Date Master Strategic Alliance Agreement was signed

Announcement date

February 25, 2026

Date partnership was publicly announced

Historical Context

5 past events · Latest: Jan 29

5 events

1. Jan 29

   Acquisition LOI

   24h Move

   -9.9%

   Binding LOI to acquire SSMC and its Phase III glioblastoma platform.

2. Jan 06

   Merger MOU

   24h Move

   -8.0%

   Non-binding MOU to merge with EG BioMed for DNA methylation AI platform.

3. Jan 05

   Roadmap update

   24h Move

   +5.7%

   Major milestones and 2026 clinical and commercial roadmap announcement.

4. Dec 16

   US expansion

   24h Move

   +1.0%

   Plans for California operations center and expanded U.S. facilities.

5. Dec 09

   Expo showcase

   24h Move

   -18.4%

   Showcasing diagnostic and precision medicine portfolio at a major expo.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

dna methylation, contract research organization, investigational new drug, new drug application, +4 more

8 terms

dna methylation medical

"advancing DNA methylation-based cancer detection technology and ophthalmologic innovations"

A chemical tag added to DNA that acts like a sticky note on a recipe, changing whether a gene is read without altering the underlying genetic code. For investors, DNA methylation matters because these tags can serve as measurable biomarkers for disease diagnosis, risk prediction, and treatment response, and they can be targets for drugs or diagnostic tests—factors that influence clinical value, regulatory approval, and market potential.

contract research organization technical

"for YC Biotech’s Contract Research Organization (“CRO”) clients in Asia"

A contract research organization (CRO) is an outside company hired to run medical and scientific work for drug, device or biotech developers—like an experienced project manager and lab team that companies rent instead of building in-house. Investors care because CROs influence development speed, quality and cost: delays or successes in trials affect client spending, regulatory risk and ultimately revenues for both the sponsor and the CRO.

investigational new drug regulatory

"including Investigational New Drug (“IND”), New Drug Application (“NDA”)"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

new drug application regulatory

"including Investigational New Drug (“IND”), New Drug Application (“NDA”)"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

biologics license application regulatory

"and Biologics License Application (“BLA”) submissions, which will provide clients"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

chemistry, manufacturing, and controls technical

"scientific compilation of CMC (Chemistry, Manufacturing, and Controls) data"

Chemistry, manufacturing, and controls (CMC) is the detailed documentation of how a drug or medical product is made, tested, and kept consistent — like a recipe, factory checklist, and quality-control plan combined. Investors care because strong CMC means regulators are more likely to approve the product and the company can reliably scale production, while weak or incomplete CMC raises the risk of approval delays, production problems, extra costs, or recalls.

investigational device exemption regulatory

"medical device filings including Investigational Device Exemption (“IDE”), 510(k), De Novo"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

510(k) regulatory

"medical device filings including Investigational Device Exemption (“IDE”), 510(k), De Novo"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Taipei, Taiwan, Feb. 25, 2026 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio Ltd” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced that its subsidiary YD Bio USA, Inc. (“YD Bio USA”) entered into a Master Strategic Alliance Agreement (the “Agreement”) with YC Biotech Co., Ltd. (“YC Biotech”) on February 24, 2026. This partnership represents a pivotal advancement in the Company’s mission, establishing YD Bio USA as the official strategic hub and exclusive U.S. Agent for regulatory applications to the U.S. Food and Drug Administration (the “FDA”) for YC Biotech’s Contract Research Organization (“CRO”) clients in Asia.

Pursuant to the Agreement, the partnership will cover FDA-related projects, including Investigational New Drug (“IND”), New Drug Application (“NDA”), and Biologics License Application (“BLA”) submissions, which will provide clients with a streamlined, integrated approach to navigating the complexities of the regulatory landscape. Through deep integration of YC Biotech’s execution capabilities in Asia and YD Bio USA’s experience engaging U.S. regulatory authorities, the companies will establish a “Taiwan-U.S. Dual-Core” regulatory platform.

Under the terms of the Agreement, YD Bio USA will serve as YC Biotech’s exclusive U.S. Agent and formal liaison with the FDA. In this role, YD Bio USA will manage official communications and correspondence with the FDA, represent sponsors in pre‑IND and other formal regulatory meetings, provide high‑level U.S. regulatory pathway strategies and positioning advice, and serve as compliance risk advisor. YD Bio USA will also coordinate FDA inspection readiness efforts to facilitate compliance with applicable U.S. regulatory requirements.

YC Biotech will lead project acquisition and technical execution for clients with U.S. regulatory requirements and provide support for regulatory submissions. YC Biotech’s responsibilities will also include preparation and drafting of comprehensive submission documentation, integration and scientific compilation of CMC (Chemistry, Manufacturing, and Controls) data, development of clinical protocols and regulatory content, overall project management to maintain timelines, and assembly of complete submission packages.

The collaboration will provide a one‑stop solution for a broad range of FDA‑related projects, including drug submissions such as IND, NDA, and BLA filings; medical device filings including Investigational Device Exemption (“IDE”), 510(k), De Novo, and Premarket Approval (“PMA”) submissions; and strategic advisory services such as pre‑IND meeting facilitation, FDA inspection support, and ongoing regulatory strategy development.

A Scalable Platform Strategy

This partnership signifies a structural upgrade to YD Bio Ltd’s business model, shifting away from a single-project advisory focus to a scalable platform strategy. The collaboration is designed to serve as a foundation for future expansion, with the potential to absorb additional Asian CROs, extend services to the European Medicines Agency (EMA), and further develop a U.S. clinical network. This would also create a pathway towards a comprehensive cross-border regulatory alliance system, enabling simultaneous engagement with multiple non‑U.S. partners, fostering long‑term recurring collaborations, and strengthening the Company’s position within the U.S. regulatory ecosystem.

“We remain committed to fostering innovation and enhancing the success of our partners within the biopharma landscape,” stated Dr. Ethan Shen, Chairman of the Board and Chief Executive Officer of YD Bio Ltd. "This alliance with YC Biotech represents a strategic alignment that allows us to better serve our clients, paving the way for success in meeting regulatory challenges."

“Our pipeline is already starting to reflect this momentum, with one project completing an INTERACT meeting, one completing a pre‑IND meeting and another project completing an IND meeting. The Company will prioritize standardizing offerings, scaling operations, and formalizing partnership agreements to capture such recurring value. As we embark on this collaborative journey, both YD Bio Ltd and YC Biotech look forward to a partnership that enriches our service offerings and supports the success and growth of our clients.”

About YD Bio Limited

YD Bio Ltd is a U.S.-anchored public biotechnology company building an integrated healthcare platform across regulated diagnostics, clinical services, and commercial healthcare markets. The Company operates DNA methylation–based oncology testing programs in the United States under an LDT-first strategy and provides compliant life science distribution and clinical trial supply chain services to pharmaceutical and biotechnology partners. In addition, YD Bio Ltd maintains regulated ocular health commercialization operations and a consumer health distribution platform in Asia. Through strategic partnerships and scalable execution capabilities, the Company advances biomedical innovation with real-world clinical and commercial impact. For more information, please visit the Company’s website: ir.ydesgroup.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, among others, statements about the partnership with YC Biotech, the anticipated benefits of such partnership, the Company’s strategy, and the future financial and operating performance of YD Bio Ltd. Forward-looking statements are based on current expectations, estimates, forecasts, and projections and are not guarantees of future performance. Investors can identify these forward-looking statements by words or phrases such as “approximates,” “believes,” “designed to,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. Actual results may differ materially due to a variety of factors, including regulatory decisions and feedback, the ability to achieve the anticipated benefits of the partnership with YC Biotech, and other risks and uncertainties described in YD Bio Ltd’s filings with the U.S. Securities and Exchange Commission (the “SEC”). The Company undertakes no obligation to update any forward-looking statements, except as required by law. The Company 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 the Company’s registration statement and other filings with the SEC.

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did YD Bio (YDES) announce on Feb 25, 2026 regarding YC Biotech?

YD Bio announced a Master Strategic Alliance Agreement with YC Biotech dated Feb 24, 2026. According to the company, the pact establishes a Taiwan-U.S. dual-core regulatory platform with YD Bio USA as exclusive U.S. Agent for FDA-facing projects.

How will the YD Bio and YC Biotech alliance affect FDA submissions for clients of YC Biotech?

The alliance centralizes FDA submissions through YD Bio USA as exclusive U.S. Agent for IND, NDA and BLA filings. According to the company, YC Biotech will prepare documentation while YD Bio USA manages FDA communications and inspection readiness.

Does the YD Bio (YDES) partnership cover medical device regulatory work as of Feb 2026?

Yes, the agreement covers medical device filings including IDE, 510(k), De Novo and PMA submissions. According to the company, the collaboration offers one-stop regulatory services spanning drug and device pathways.

What strategic shift did YD Bio (YDES) describe in the Feb 25, 2026 release?

YD Bio said it is shifting from single-project advisory to a scalable platform strategy to enable recurring cross-border collaborations. According to the company, this foundation aims to onboard additional Asian CROs and expand regulatory networks.

What immediate project progress did YD Bio note after forming the YC Biotech alliance?

The company reported one project completed an INTERACT meeting, one completed a pre-IND meeting, and another completed an IND meeting. According to the company, these milestones reflect early momentum and pipeline activity.