Press release
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)
New Taipei City, Taiwan, Aug. 22, 2025 (GLOBE NEWSWIRE) -- Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company”, “Jyong Biotech”), a science-driven biotechnology
About this update from Jyong Biotech Ltd.
[{"type":"text","content":"New Taipei City, Taiwan, Aug. 22, 2025 (GLOBE NEWSWIRE) -- Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company”, “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, 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 August 14–17, 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 pivotal studies (BOTRESO® vs. placebo) and two open-label extension studies (all participants received BOTRESO®). The two pivotal studies lasted 12 weeks and were designed to evaluate the clinical efficacy of BOTRESO® compared to placebo—specifically to determine whether the difference between groups reached statistical significance. The open-label extension studies, in which no placebo group was included and all participants took BOTRESO®, assessed the long-term safety of the drug for up to 52 weeks (1 year). The results showed that in the Intention-to-Treat (ITT) population(includes all patients who took at least one dose of the investigational drug, whether BOTRESO® or placebo), there was no significant difference between groups in the U.S. subgroup. However, in the Asian subgroup (Taiwan) 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. Importantly, the incidence of adverse events did not increase in the BOTRESO® group, and no serious adverse events related to BOTRESO® were reported. Current pharmacologic treatments for BPH, such as α‑blockers and 5‑α‑reductase inhibitors, have been associated in published literature (The Journal of Urology, February 2021) with increased risk of heart failur...