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 that it has achieved another milestone in the development of its plant-derived new drug MCS-8 (PCP).

The Company has completed the statistical analysis of the primary efficacy endpoints in its ongoing Phase II clinical trial conducted in Taiwan, following the randomized and placebo-controlled trial conducted to over 700 high-risk subjects enrolled into the Phase II clinical trial since its commencement. The data indicated that, compared with placebo, MCS-8 (PCP) demonstrated lower incidence rates of prostate cancer and high-grade prostate cancer (Total Gleason Score ≥ 7) with good overall tolerability, which lays an important foundation for potential future multinational Phase III clinical trials.

The MCS-8 (PCP) Phase II study was a randomized, placebo-controlled trial conducted across 20 hospitals in Taiwan with participation from over 130 urologists—representing more than one-tenth of all urologists nationwide. The trial enrolled more than 700 high-risk subjects, each receiving two years of treatment (either MCS-8 (PCP) or placebo).

Key findings showed the following:

• Primary efficacy endpoint:
  
  Compared with placebo, the MCS-8 group indicated a 27.3% reduction in prostate cancer incidence.
   
• Secondary efficacy endpoint:
  
  Based on maximum Gleason score, the incidence of high-grade prostate cancer (Total Gleason Score ≥ 7) showed a 17.1% reduction compared with placebo.

Safety assessments also showed:

• Two-year administration of MCS-8 did not increase adverse event rates,
• No serious adverse events related to MCS-8 were observed,
• No negative impact on liver function (AST, ALT), kidney function (BUN, Creatinine), fasting glucose, or blood pressure (systolic/diastolic).

Moreover, in the placebo group, fasting glucose significantly increased (P = 0.022), and the triglycerides (TG), LDL, and HDL showed no significant differences. However, in the MCS-8 group, observed favorable lipid-modulating trends after two years of treatment compared with baseline:

• TG decreased (P = 0.05)
• LDL significantly decreased (P = 0.018)
• HDL significantly increased (P = 0.003)

The Company believes that these findings highlight the safety and tolerability of MCS-8 and suggest that there might be potential for future clinical studies in lipid management, atherosclerosis, and cardiovascular diseases.

Throughout the development of MCS-8 (PCP), the Company has adhered closely to U.S. FDA guidelines and standards, conducting rigorous scientific validation and clinical testing.

"These positive results affirm the potential of MCS-8 (PCP) as a compelling candidate for prostate cancer prevention," said Fu-Feng Kuo, Chairwoman and CEO of Jyong Biotech. "With good safety and efficacy signals, we are now preparing for the next stage of development. Our objective is to initiate a global Phase III trial, in collaboration with international pharmaceutical companies to further validate its clinical potential."

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