Jyong Biotech Presents Topline Results at Urological Association of Asia Congress.

Jyong Biotech has announced participation in the 22nd Urological Association of Asia Congress and exhibited topline results from 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 pivotal studies and two open-label extension studies.

Jyong Biotech Ltd. (Nasdaq: MENS) recently participated in the 22nd Urological Association of Asia Congress, where it showcased topline results from its clinical studies for two key drug candidates: BOTRESO® for benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), and MCS-8 (PCP) for potential prevention of prostate cancer [1].

The Phase III clinical trials of BOTRESO® included two pivotal studies and two open-label extension studies. The pivotal studies, which lasted 12 weeks, evaluated the clinical efficacy of BOTRESO® compared to placebo. The open-label extension studies, where all participants received BOTRESO®, assessed the long-term safety of the drug over 52 weeks. The results showed no significant difference between groups in the U.S. subgroup, but there was a statistically significant improvement in lower urinary tract symptoms in the Asian (Taiwan) subgroup and the pooled Taiwan-U.S. population [1].

The 52-week extension studies demonstrated consistent long-term improvement with no serious adverse events. This positions BOTRESO® favorably against current treatments like α-blockers and 5-α-reductase inhibitors, which carry cardiovascular and prostate cancer risks [1].

For MCS-8 (PCP), the Phase II trial met its primary efficacy endpoint, showing lower rates of positive prostate biopsies and high-grade prostate cancer compared to placebo over 104 weeks. No treatment-related serious adverse events were observed, providing sufficient evidence to advance MCS-8 to Phase III evaluation [1].

The global BPH market is projected to reach $9.8 billion by 2026, up from $4.1 billion in 2020. Jyong Biotech maintains global patent coverage and is pursuing international partnerships for market entry [1].

References:
[1] https://www.globenewswire.com/news-release/2025/08/22/3137831/0/en/Jyong-Biotech-Ltd-Participated-in-the-22nd-Urological-Association-of-Asia-Congress-to-Display-the-Clinical-Data-for-its-Phase-III-Studies-of-BOTRESO-and-Phase-II-Study-of-MCS-8-PCP.html