FDA agrees to provide written guidance by January 4, 2027, to support development of YDB-LMSCEV-001
TAIPEI, Taiwan, Nov. 12, 2026 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection and ophthalmologic innovations, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted its request for an INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting.
Through this program, the FDA will provide early written regulatory feedback on YDB-LMSCEV-001, the Company’s investigational biologic eye drop for moderate-to-severe dry eye disease. This early-stage product uses extracellular vesicles (“EVs”), naturally occurring particles derived from healthy donor eye stem cells specifically known as allogeneic human limbal mesenchymal stem cells (“LMSCs”).
In a letter dated November 9, 2026, CBER (the FDA’s Center for Biologics Evaluation and Research) acknowledged receipt of the Company’s meeting request and briefing package submitted on October 21, 2026, and agreed to provide feedback via a Written Response Only format, with answers expected by January 4, 2027.
Key Highlights
- Meeting Granted: CBER agreed to YD Bio’s request for an INTERACT meeting via a Written Response Only format.
- Timeline: Written feedback is expected by January 4, 2027.
- Scope of Questions: YD Bio asked the FDA nine specific questions: seven on chemistry, manufacturing, and controls, covering topics such as cell bank qualification, donor eligibility, and product safety and consistency; and two on the design of early animal testing (nonclinical proof-of-concept).
- Goal: The feedback will help finalize manufacturing and preclinical plans before a formal pre-Investigational New Drug (“pre-IND”) meeting, which is the key regulatory step before human trials.
Early Regulatory Engagement for an Emerging Technology
The INTERACT program allows developers of highly innovative medical products to obtain early, informal, and non-binding advice from the FDA before a formal pre-IND meeting. Because EV-based therapies remain an emerging class of biologics, early guidance on the characterization and manufacture of such products is a critical developmental step.
Current Progress & Next Steps
To date, YD Bio has established laboratory-scale donor master cell banks for stem cells and completed initial lab and mouse studies for dry eye disease. The Company also submitted a proposed follow-up proof-of-concept animal study to the FDA for review.
Once the FDA provides a written response, YD Bio plans to incorporate the feedback to optimize its manufacturing processes and finalize the design of its confirming animal studies. This is expected to prepare the Company for the studies required to eventually apply for human clinical trials (“IND enabling studies”).
Taiwan-based YC Biotech Co., Ltd. (“YC Biotech”) consulted on the FDA submission, with YD Bio USA, Inc., a subsidiary of the Company, acting as U.S. agent and formal liaison with the FDA, building on the partnership for regulatory collaboration previously announced on February 25, 2026.
“For a product class as new as extracellular vesicles, we believe the most useful time to hear from the FDA is before the clinical manufacturing process and before specifications are fixed,” said Dr. Ethan Shen, Founder, Chairman and Chief Executive Officer of YD Bio. “We appreciate CBER’s agreement to provide written feedback on YDB-LMSCEV-001, and we intend to use its responses to shape our manufacturing, potency and nonclinical plans as we work toward a pre-IND meeting.”
About YDB-LMSCEV-001
YDB-LMSCEV-001 is an investigational topical ophthalmic biologic candidate composed of extracellular vesicles derived from allogeneic human LMSCs, which is being developed for moderate-to-severe dry eye disease. YDB-LMSCEV-001 is an investigational product and has not been approved for marketing by the FDA or any other regulatory authority. Its safety and efficacy have not been established.
About YD Bio Limited
YD Bio is a U.S.-anchored public biotechnology company building an integrated healthcare platform spanning regulated molecular diagnostics, clinical services, precision medicine, and life science commercialization. The Company operates DNA methylation–based oncology testing programs in the United States under a laboratory-developed test strategy and supports pharmaceutical and biotechnology partners through compliant life science distribution and clinical trial supply chain services. In addition, the Company maintains regulated ocular health commercialization operations and a consumer health distribution platform in Asia. For more information, visit ir.ydesgroup.com and follow the Company on Facebook, X, Threads, Instagram and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions created by the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and content of the FDA’s written responses, the anticipated incorporation of any FDA feedback by the Company, the regulatory timelines related to the products discussed on this press release, and any planned development activities for YDB-LMSCEV-001 specifically, including a confirmatory proof-of-concept study, a potential pre-IND meeting, IND-enabling studies, a future IND application, and the continued partnership with YC Biotech. Forward-looking statements are not guarantees of future performance and can be identified by words such as “aim,” “intend,” “seek,” “believe,” “designed to,” “expects,” “anticipates,” “plans,” “may,” “could,” “will” and other similar expressions. Forward-looking statements are based on management’s current belief based on currently available information. Such statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, and actual results may differ materially from those expressed or implied due to a variety of factors. For example, the FDA’s responses under the INTERACT program will be informal and non-binding, may not address all of the Company’s questions, and may not be favorable; and there can be no assurance as to their timing or content, or that the FDA will agree with any of the Company’s proposals at a pre-IND meeting or otherwise. YDB-LMSCEV-001 is at the preclinical stage; preclinical results are not necessarily predictive of clinical results, and no clinical safety or efficacy of YDB-LMSCEV-001 has been established. In addition, additional risks and uncertainties that could materially affect results include, but are not limited to, the Company’s ability to incorporate any feedback from regulatory agencies, including the FDA, and comply with their requirements; the Company’s ability to secure necessary supplies and materials, successfully establish a clinical manufacturing process and complete product characterization, potency assay development and IND-enabling studies, and secure any necessary funding; continued cooperation by the Company’s partners, including YC Biotech; competition; changes in the regulatory landscape; geopolitical tensions; macroeconomic conditions, and other risks and uncertainties described in YD Bio’s filings with the U.S. Securities and Exchange Commission (the “SEC”). The Company cautions investors not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update any forward-looking statements, except as required by law, and encourages investors to review the risk factors in its Annual Report on Form 20-F and other SEC filings.
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