TAIPEI, March 28, 2026 /PRNewswire/ -- Jyong Biotech Ltd. (Nasdaq: MENS) (the "Company" or "Jyong Biotech"), a science-driven biotechnology company dedicated to the development and commercialization of innovative plant-derived therapeutics, today provided an update on the plant-derived innovative drug MCS®-2 of its multiple competitive advantages and its potential clinical benefits in the treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS).

• Pioneering Plant-Based Therapeutics
  Developed in Taiwan, MCS®-2 is the world's only oral botanical new drug 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 U.S. and Taiwan, including two pivotal trials (one in the U.S. and one in Taiwan) and two open-label extension studies (one in the U.S. and one in Taiwan), and completion of the Phase III clinical trial report was achieved in 2017.
  
  In the U.S., trials were conducted across 27 centers in 19 states, involving over 200 urologists. In Taiwan, trials took place in 12 major hospitals, including multiple medical centers, with participation from more than 70 urologists (over one-tenth of all urologists in Taiwan). The Company believes that this extensive physician network lays 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 through Phase III clinical validation, along with more than ten international toxicology studies. Across all four Phase III trials in Taiwan and the U.S., the drug demonstrated excellent safety, with no serious adverse events, supporting its suitability for long-term use.
  
  
• Global Patent Protection:
  The company believes that its core technology significantly enhances 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 across the Americas, Asia, Europe, and other regions, forming a global portfolio that effectively overcomes existing patent barriers established by major pharmaceutical companies.
  
  
• Large Market Potential for Target Indications:
  BPH/LUTS is a common age-related condition affecting 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 unmet need for a safe, long-term therapeutic solution. MCS®-2 is being developed to address this gap, offering clear competitive advantages.
  
  The Company believes that with global population aging and increasing healthcare demand, the market for prostate disease treatment and prevention presents 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, continuously expanding its scope and vision. The company places strong emphasis on quality and regulatory compliance, strictly adhering to international standards to ensure the safety and quality of its products. Through these efforts, Jyong Biotech believes that it is well-positioned to enter global markets, promote cross-border collaborations and licensing models, and create broader opportunities for partnerships worldwide.

"We are proud to lead the development of Taiwan's first oral botanical new drug to advance into Phase III clinical trials," stated Fu-Feng Kuo, Chairwoman 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."

As of present day, 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 complete updates on material developments.

About Jyong Biotech Ltd.

Headquartered in Taiwan, Jyong Biotech Ltd. is a science-driven biotechnology company committed to developing and commercializing innovative and differentiated new drugs (plant-derived), mainly specializing in the treatment of urinary system diseases, with an initial focus on the markets of the U.S., the EU and Asia. Since its inception in 2002, the Company has built integrated capabilities that encompass all key functionalities 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 been developing a series of botanical drug candidates, including its primary botanical drug candidate, BOTRESO^®, another clinical-stage botanical drug candidate, and other preclinical-stage botanical drug candidates. The Company endeavors to develop and supply first-class innovative drugs to meet customers' health needs and seeks to be a valuable business organization that is 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 concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. 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, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the 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, the uncertainties related to market conditions and other factors discussed in the "Risk Factors" section of the registration statement, prospectuses, annual and interim reports, and other filings with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

For more information, please contact:
Jyong Biotech Ltd.
ir@jyongbio.com

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