Jyong Biotech Announces Updated Statistical Analyses For Key Blood Biochemical Markers From Phase II Clinical Trial Of MCS-8 Conducted In Taiwan

Jyong Biotech Ltd. (NASDAQ:MENS) (the "Company" or "Jyong Biotech"), a science-driven biotechnology company based in Taiwan 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, today announced updated statistical analyses for key blood biochemical markers from its Phase II clinical trial of MCS-8 (PCP) conducted in Taiwan. The results underscore MCS-8's previously indicated multifaceted clinical and commercial potential beyond its clinical evidence in prostate cancer prevention, showing its potential in helping alleviate high-grade malignancy risk. The data reveals significant new value in metabolic indicators, specifically cholesterol and lactate dehydrogenase (LDH). Building on this momentum, the Company is evaluating the feasibility of expanding MCS-8's indications to include lipid management, atherosclerosis, and cardiovascular diseases—a strategic move aimed at extending the product's lifecycle and significantly capturing a broader market share.

The Phase II clinical trial demonstrated that after two years of treatment, subjects receiving MCS-8 showed improved lipid control compared with baseline, including:

• A statistically significant reduction in total cholesterol levels (P = 0.036);
• A statistically significant increase in serum lactate dehydrogenase (LDH) levels observed in the placebo group (P = 0.024), while no such increase was observed in the MCS-8 group.

LDH is an enzyme widely present in organs and tissues throughout the body, and elevated serum LDH levels are commonly associated with cellular damage or cell death. The absence of LDH elevation in the MCS-8 group suggests that MCS-8 may not be causing damage or death to the cell.

As previously disclosed, the primary efficacy endpoint of the Phase II study showed that, compared with placebo, the MCS-8 group demonstrated a 27.3% reduction in overall prostate cancer incidence. In addition, the incidence of high-grade prostate cancer (Total Gleason Score ≥ 7) was reduced by 17.1% compared with placebo. Further pathological analyses demonstrated favorable trends, including a 35.2% reduction in the percentage of positive cores involved at diagnosis and a 24.4% reduction in the percentage of cancer-positive area involved in positive cores, compared with placebo, suggesting improved control of disease progression. Safety data from the previously disclosed analyses showed that long-term administration of MCS-8 for two years did not increase the rate of adverse events. No serious adverse events related to MCS-8 were observed, and no negative effects were identified on liver function, kidney function, or blood pressure. Company believes that the favorable tolerability profile supports the potential suitability of MCS-8 for long-term preventive use.

MCS-8 is developed using Jyong Biotech's core patented pharmaceutical composition technology, which Company believes significantly enhances bioavailability and improves physiological efficacy, offering substantial potential for the development of multiple dosage forms and indications.

Related research findings have been published in the international journal Nanotechnology and included by Global Medical Discovery institutions in Canada.

MCS-8 remains an investigational new drug candidate and has not been approved for commercial use in any jurisdiction.