Jyong Biotech to present clinical data from studies of BOTRESO, MCS-8

Jyong Biotech (MENS) announced its participation in the 22nd Urological Association of Asia Congress which was held in conjunction with the 47th Annual Meeting of the Taiwan Urological Association on August14-17,2025, and exhibited topline results from the multiple clinical studies of its proprietary drug candidates BOTRESO for benign prostatic hyperplasia, BPH, and lower urinary tract symptoms, LUTS, and MCS-8, PCP, for the potential prevention of prostate cancer. The Phase III clinical trials of BOTRESO consisted of two studies and two open-label extension studies. The results showed that in the Intention-to-Treat population, there was no significant difference between groups in the U.S. subgroup. However, in the Asian subgroup and the pooled Taiwan-U.S. population, the BOTRESO group showed a statistically significant improvement in lower urinary tract symptoms compared to placebo. Moreover, in the 52-week open-label extension studies, BOTRESO consistently showed long-term improvement from baseline. For MCS-8, the PhaseII trial met its primary efficacy analysis. Compared with placebo, 104weeks of administration was associated with lower rates of positive prostate biopsies and high-grade prostate cancer. No MCS-8 treatment-related serious adverse events were observed. The Company believes that these findings provide a basis for advancing MCS-8 into PhaseIII evaluation, subject to regulatory guidance. Because of the safety concerns of current chemical drugs, the doctors recommended the Company to conduct MCS-8 clinical study. The Company is also in discussions with global pharmaceutical partners regarding the further development of MCS-8, with the goal of initiating large-scale PhaseIII trials involving thousands to tens of thousands of participants to further evaluate its preventive potential.