TAIPEI, March 28, 2026 /PRNewswire/ — Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company” or “Jyong Biotech”), a science-based biotechnology company dedicated to the development and commercialization of innovative plant-based therapeutic products, today provided an update on the innovative plant-based drug MCS®-2, its multiple competitive advantages and its potential clinical benefits in the treatment of benign prostatic hyperplasia/lower urinary tract symptoms. (HBP/TUBA).
- Pioneering herbal therapeutics
Developed in Taiwan, MCS®-2 is the world’s only new oral botanical medicine to have completed a global Phase III clinical trial for benign prostatic hyperplasia (BPH). Jyong Biotech has conducted four phase III clinical trials (API-1) in the United States and Taiwan, including two pivotal trials (one in the United States and one in Taiwan) and two open-label extension studies (one in the United States and one in Taiwan), and the completion of the phase III clinical trial report was completed in 2017.
In the United States, trials were conducted at 27 centers in 19 states, involving more than 200 urologists. In Taiwan, trials took place in 12 major hospitals, including several medical centers, with the participation of more than 70 urologists (more than a tenth of all urologists in Taiwan). The Company believes that this extensive physician network provides a strong foundation for future commercialization and expansion into new indications.
- Rigorous scientific validation and clinical evidence:
Jyong Biotech strictly adheres to FDA guidelines and standards throughout its drug development process. MCS®-2 (API-1) has completed phase I to phase III clinical validation, as well as more than ten international toxicology studies. In four phase III trials conducted in Taiwan and the United States, the drug demonstrated excellent safety, with no serious adverse effects, supporting its suitability for long-term use. - Global patent protection:
The Company believes its core technology significantly improves bioavailability and enables the development of multiple formulations and indications, including oral formulations, injectable forms and bladder instillation therapies. These innovations are protected by patents in the Americas, Asia, Europe and other regions, forming a global portfolio that effectively overcomes existing patent barriers established by large pharmaceutical companies. - Large market potential for target indications:
BPH/LUTS is a common age-related disease that affects hundreds of millions of men worldwide.
Current treatments for BPH/LUTS are associated with side effects and drug resistance, impacting patient compliance and satisfaction. There is therefore an urgent and unmet need for a safe and long-term therapeutic solution. MCS®-2 is being developed to fill this gap, providing clear competitive advantages.
The Company believes that with the aging of the global population and increasing demand for healthcare, the prostate disease treatment and prevention market has substantial growth potential. Jyong Biotech remains committed to advancing innovative R&D to provide safer, evidence-based solutions.
Since its establishment, Jyong Biotech has remained committed to innovation and R&D, continually expanding its scope and vision. The company places great importance on quality and compliance with regulations, strictly adhering to international standards to ensure the safety and quality of its products. Through these efforts, Jyong Biotech believes it is well positioned to enter global markets, promote cross-border collaborations and licensing models, and create broader partnership opportunities around the world.
“We are proud to lead the development of Taiwan’s first new oral botanical drug to advance to Phase III clinical trials,” said Fu-Feng Kuo, President and CEO of Jyong Biotech. “MCS®-2 reflects our commitment to innovation and has the potential to provide safer, long-term solutions for patients with BPH/LUTS. We look forward to expanding our global impact through continued research and development.
At this time, MCS-2 remains an investigational new drug candidate and has not been approved for commercial use in any jurisdiction. Jyong Biotech will comply with applicable regulatory disclosure obligations and provide timely, accurate and comprehensive updates on important developments.
About Jyong Biotech Ltd.
Headquartered in Taiwan, Jyong Biotech Ltd. is a science-based biotechnology company committed to developing and commercializing innovative and differentiated new medicines (plant-derived), primarily specializing in the treatment of urinary system diseases, with an initial focus on the US, EU and Asian markets. Since its inception in 2002, the Company has built integrated capabilities that encompass all key capabilities of drug development, including early-stage drug discovery and development, pharmacology, toxicology, clinical trials, regulatory affairs, manufacturing and commercialization. Leveraging strong research and development capabilities and a proprietary platform, the Company has developed a series of botanical drug candidates, including its lead botanical drug candidate, BOTRESO.®another botanical drug candidate in the clinical stage, and other botanical drug candidates in the preclinical stage. The Company strives to develop and deliver first-class innovative medicines to meet the healthcare needs of customers and seeks to be a valuable business organization held in high esteem by the public.
For more information, please visit: https://www.jyongbio.com/, https://jyongir.com/.
Forward-looking statement
This press release contains forward-looking statements. Forward-looking statements include statements regarding plans, objectives, goals, strategies, future events or performance, as well as underlying assumptions and other statements that are not statements of historical fact. When the Company uses words such as “may,” “will,” “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, the Company is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks, including, but not limited to, uncertainties relating to market conditions and other factors discussed in the “Risk Factors” section of the registration statement, prospectuses, annual and interim reports and other documents filed with the SEC. For these and other reasons, investors are cautioned not to place undue reliance on the forward-looking statements contained in this press release. Additional factors are discussed in the Company’s SEC filings, which can be found at: www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances occurring after the date hereof.
For more information, please contact:
Jyong Biotech Ltd.
ir@jyongbio.com
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