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 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 failure, and the Safety Announcement from U.S. FDA (June 9, 2011) has noted a potential increased risk of high‑grade prostate cancer with 5‑ARIs. However, BOTRESO® indicated excellent improvement and tolerance in the four Phase III clinical trials.
BOTRESO® is locally developed in Taiwan, and this is the first case that a Taiwanese-developed oral botanical drug has been approved IND (Investigational New Drug) number from the U.S. FDA to proceed to Phase III clinical trials. The Company has developed additional drug substance (API-2) under the same patent of API-1, and is collecting all the related CMC documents per U.S. FDA requirements. Jyong Biotech intends to integrate Taiwan‑U.S. clinical data for the NDA (New Drug Application) submission to the U.S. FDA.
In 2020, the U.S. BPH patient population reached approximately 4.7 million, an increase of about 6.8% from 2017. Globally, the number of BPH patients grew from 88.4 million in 2017 to 94.2 million in 2020 (up 6.5%). The global BPH drug market expanded from $3.7 billion in 2017 to $4.1 billion in 2020 and is projected to reach $9.8 billion by 2026.
For MCS‑8 (PCP), the Phase II trial met its primary efficacy analysis. Compared with placebo, 104 weeks of administration was associated with lower rates of positive prostate biopsies and high‑grade prostate cancer. No MCS-8 (PCP) treatment‑related serious adverse events were observed. The Company believes that these findings provide a basis for advancing MCS‑8 into Phase III 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 Phase III trials involving thousands to tens of thousands of participants to further evaluate its preventive potential.
All clinical research has been conducted in accordance with U.S. FDA guidance, Jyong Biotech maintains global patent coverage for BOTRESO® across Asia, the Americas, and the European Union. The Company has signed multiple letters of intent and licensing agreements with international pharmaceutical partners, executed its first licensing and continues to pursue collaborations and royalty-bearing partnerships to support global market entry.
About Jyong Biotech Ltd.
Headquartered in Taiwan, Jyong Biotech Ltd. is a science-driven biotechnology company 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. Since its inception in 2002, the Company has built integrated capabilities that encompass all key functionalities of drug development, including early-stage drug discovery and development, clinical trials, regulatory affairs, manufacturing, and commercialization. Leveraging strong research and development capabilities and a proprietary platform, the Company has been developing a series of botanical drug candidates, including its primary botanical drug candidate, BOTRESO®, another clinical-stage botanical drug candidate, and other preclinical-stage botanical drug candidates. The Company endeavors to develop and supply first-class innovative drugs to meet customers’ health needs and seeks to be a valuable business organization that is held in high esteem by the public.
For more information, please visit: https://www.jyongbio.com/, https://jyongir.com/.
Forward-Looking Statement
This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the uncertainties related to market conditions and other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.
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