JY BioMed and YC Biotech Initiate a New Phase in Stemis™ Clinical Development — FDA Pre-IND Meeting Application Submitted

Taipei, September 17, 2025

JY BioMed Co., Ltd. (集研生醫股份有限公司) and YC Biotech Co., Ltd. (昱君生技股份有限公司) jointly announced that they have officially submitted a Pre-Investigational New Drug (Pre-IND) Meeting request to the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) for Stemis™, a human umbilical cord-derived mesenchymal stem cell (hUC-MSC) therapy. Alongside the request, the companies have also provided a complete meeting briefing package, marking a pivotal milestone in the product’s progression toward clinical development.

Stemis™ is a cell therapy product derived from mesenchymal stem cells obtained from Wharton’s Jelly of the human umbilical cord, developed for the treatment of Frailty Syndrome in the elderly. Frailty Syndrome is a multifactorial geriatric condition resulting from the decline of multiple physiological systems, characterized by reduced muscle strength, slower gait, fatigue, weight loss, and diminished daily function. With the rapid growth of the global aging population, frailty has become a major challenge in public health and long-term care policies. It significantly increases the risks of falls, disability, hospitalization, and mortality, leading to heavy medical and social burdens. Therefore, novel biologically driven therapeutic interventions are urgently needed to slow down or reverse its progression.

Stemis™ leverages the immunomodulatory, antioxidant, and tissue-repair-promoting properties of mesenchymal stem cells to potentially reduce chronic inflammation, preserve muscle and organ function, and restore physiological reserve capacity, offering a promising therapeutic approach for frailty. The Phase I clinical trial will primarily focus on evaluating the safety and tolerability of the product, with exploratory endpoints assessing functional improvements and quality of life.

According to the development plan, the FDA meeting is expected to take place in late November 2025. This submission represents one of the few Taiwan-originated umbilical cord-derived stem cell products advancing through the U.S. regulatory pathway, signifying an important step toward aligning domestic regenerative medicine development with international regulatory standards.

About JY BioMed

JY BioMed is a biotechnology company dedicated to the research, development, and commercialization of cell- and exosome-based therapeutics for oncology, immunology, and regenerative medicine. Our pipeline includes programs in mesenchymal stem cells (MSCs), dendritic cell cancer vaccines, γδ T cells, NK cell therapy, and antibody-drug conjugates (ADCs), supported by partnerships with leading academic and clinical institutions.

Disclaimer

Stemis™ is an investigational cell therapy product that has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Its safety and efficacy have not been established. Any forward-looking statements in this release, including those related to clinical development plans, regulatory timelines, or therapeutic potential, are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied. JY BioMed undertakes no obligation to update or revise these statements based on new information or future events.