JY BioMed Receives FDA “Study May Proceed” Notification for Phase 1 Clinical Trial of MSC Therapy in Frailty Syndrome

Taipei, Taiwan — January 18, 2026 —

Ji Yan Biomedical Co., Ltd. (JY BioMed) today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company’s Investigational New Drug (IND) application for Stemis™, an investigational mesenchymal stem cell (MSC) therapy, and has issued a “Study May Proceed” notification. This clearance allows JY BioMed to initiate its Phase 1 clinical trial evaluating Stemis™ in elderly participants with mild to moderate frailty syndrome.

The Phase 1 study (Protocol No. JY-STEMIS-007) is a randomized, double-blind, placebo-controlled, dose-escalation trial designed to assess the safety and tolerability of intravenously administered Stemis™. The study will enroll elderly participants diagnosed with frailty syndrome, a condition associated with increased vulnerability to adverse health outcomes and limited therapeutic options.

“Receiving the FDA’s ‘Study May Proceed’ notification represents a critical regulatory milestone for JY BioMed,” said Dr. Ethan Shen, Chairman of JY BioMed. “This clearance confirms that the FDA has completed its safety review of our IND and allows us to move forward with first-in-human clinical evaluation of Stemis™. We believe this study marks an important step toward developing innovative cell-based therapies for aging-related conditions with significant unmet medical needs.”

Stemis™ is an investigational MSC product manufactured under controlled conditions and intended for intravenous administration. The Phase 1 trial will focus on evaluating safety outcomes across escalating dose levels, while also collecting exploratory data to support future clinical development.

Frailty syndrome is increasingly recognized as a major public health challenge in aging populations worldwide, yet effective disease-modifying treatments remain limited. JY BioMed’s clinical development program aims to explore the potential of MSC-based therapies to address systemic functional decline associated with frailty.

The Company plans to initiate participant enrollment following Institutional Review Board (IRB) approval and completion of site activation procedures.

About Ji Yan Biomedical Co., Ltd (JY BioMed)

Ji Yan Biomedical Co., Ltd. (JY BioMed) is a clinical-stage biotechnology company focused on the development of advanced cell-based therapies for unmet medical needs. Leveraging proprietary platforms in cell processing and translational medicine, JY BioMed is advancing a pipeline of investigational products targeting aging-related disorders, oncology, and regenerative medicine.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the initiation, conduct, and potential outcomes of clinical trials. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Investigational products described herein have not been approved by the U.S. Food and Drug Administration for any indication.