Jyong Biotech Reports Transformative Period of Clinical Validation and Commercialization Attempt: Phase II Data Focuses on Dual Therapeutic Potential of MCS-8 in Oncology and Metabolic Health, Alongside Strategic Market Entry into Asia

- Comprehensive review of recent milestones highlights statistically significant efficacy in prostate cancer prevention, discovery of novel lipid-modulating properties, and the execution of high-value commercial partnerships in South Korea and Vietnam.

New Taipei City, Taiwan, Feb. 12, 2026 (GLOBE NEWSWIRE) -- 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 issued a strategic corporate update. This review encapsulates a pivotal period characterized by the successful completion of the Phase II clinical trial for its lead candidate, MCS-8, and the concurrent attempt of its commercial footprint in key Asian markets. The Company believes the convergence of positive oncological endpoints with unexpected metabolic benefits potentially de-risks its pipeline and positions Jyong Biotech at the forefront of preventative medicine.

Unlocking the "Dual-Action" Potential of MCS-8: Oncology Meets Metabolic Health

The Company recently achieved an important milestone with the completion of its Phase II randomized, placebo-controlled trial for MCS-8, which enrolled over 700 high-risk subjects across 20 medical centers in Taiwan. As previously disclosed, the study’s primary efficacy analysis yielded a statistically significant 27.3% reduction in the overall incidence of prostate cancer in the MCS-8 arm compared to placebo. The data also demonstrated a 17.1% reduction in high-grade prostate cancer (Total Gleason Score ≥ 7). This finding is clinically profound, as high-grade malignancies represent the primary driver of prostate cancer mortality, and historical chemoprevention agents have often struggled to demonstrate safety or efficacy in this specific sub-population.

Further pathological stratification revealed a 35.2% reduction in the percentage of positive biopsy cores and a 24.4% reduction in the cancer-positive area within those cores. These metrics suggest that MCS-8 exerts a tangible biological effect on tumor burden and disease progression, potentially offering a superior alternative to the current standard of "active surveillance," which carries the psychological burden of anxiety for patients waiting for disease progression.

Beyond its oncological efficacy, the Phase II data unveiled a significant secondary potential therapeutic profile regarding metabolic regulation. In results announced in January 2026, patients treated with MCS-8 for two years exhibited a statistically significant reduction in total cholesterol (P = 0.036). The study further highlighted a favorable lipid-modulating trend where the MCS-8 group showed decreased triglycerides (P = 0.05) and LDL levels (P = 0.018), alongside a significant increase in HDL (P = 0.003). In contrast, the placebo group experienced a statistically significant rise in fasting glucose (P = 0.022).

From a scientific perspective, the link between metabolic syndrome—characterized by dyslipidemia and hyperglycemia—and prostate carcinogenesis is well-documented in oncological literature. The ability of MCS-8 to simultaneously lower cancer incidence while improving the lipid profile suggests a potential synergistic mechanism of action that targets the metabolic dysregulation often fueling tumor growth. This "dual-action" capability supports the Company’s strategic evaluation of expanding MCS-8’s indications to include atherosclerosis and cardiovascular disease management.

Safety Profile and Cytoprotective Indicators

Long-term safety remains the primary barrier to entry for preventative therapies. The Phase II study provided significant indications of MCS-8’s safety profile over a two-year administration period. There were no serious adverse events related to the drug, and no negative impacts were observed on blood pressure, liver or kidney function.

Notably, the analysis of Lactate Dehydrogenase (LDH), a ubiquitous enzyme used as a clinical marker for tissue damage and cellular necrosis, offered further validation of safety. The placebo group exhibited a statistically significant increase in serum LDH levels (P = 0.024) over the trial period, potentially indicating baseline cellular stress or turnover inherent to the aging high-risk population. Conversely, the MCS-8 group showed no such elevation. The stability of LDH levels in the treatment arm serves as a biomarker for cytoprotection, reinforcing the hypothesis that MCS-8 does not induce cellular toxicity, a critical differentiator for a drug intended for long-term prophylactic use.

Embarking Commercialization via Non-Binding Strategic Asian Partnerships

Parallel to its clinical successes, Jyong Biotech has executed on its strategy to monetize its pipeline through regional co-commercialization. In late 2025, the Company formalized a non-binding Letter of Intent (LOI) with a premier South Korean pharmaceutical company to evaluate the in-licensing of MCS-2. As a recognized supplier to general hospitals and clinics, this partner offers the requisite infrastructure to navigate South Korea’s sophisticated regulatory landscape and reimbursement systems.

Subsequently, the Company expanded this initiative into Southeast Asia through a Memorandum of Understanding (MOU) with a specialized pharmaceutical distributor based in Ho Chi Minh City, Vietnam. This agreement initiates due diligence to define the regulatory and commercial pathway for MCS-2 in Vietnam, a market characterized by a rapidly aging population and increasing demand for urological therapeutics.

Management Commentary

“We believe that the past year has transformed Jyong Biotech from a development-stage entity into a company with clinically validated, multi-indication assets,” stated Fu-Feng Kuo, Chairwoman and CEO of Jyong Biotech. “The Phase II data for MCS-8 is particularly exciting because it addresses two of the most prevalent health concerns in the aging male population: prostate cancer risk and metabolic health. By demonstrating that we can potentially reduce cancer incidence while simultaneously improving lipid profiles, we have established a strong scientific foundation for our global Phase III trials in the future. Furthermore, our non-binding strategic alliances in Korea and Vietnam demonstrate our commitment to ensuring these innovative therapies reach patients efficiently. We are moving forward with a clear vision to redefine the standard of care in preventative urology.”

As of present day, MCS-2 and MCS-8 remain investigational new drug candidates and have 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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