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)
Jyong Biotech (NASDAQ:MENS) presented clinical trial results at the 22nd Urological Association of Asia Congress for two key drug candidates. The company's Phase III trials for BOTRESO®, targeting benign prostatic hyperplasia (BPH), showed significant improvement in lower urinary tract symptoms for Asian and pooled Taiwan-U.S. populations, though U.S. subgroup results were not significant. The 52-week extension studies demonstrated consistent long-term improvement with no serious adverse events.
Additionally, their Phase II trial for MCS-8 (PCP) met primary efficacy endpoints, showing lower rates of positive prostate biopsies and high-grade prostate cancer compared to placebo after 104 weeks. 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.
Jyong Biotech (NASDAQ:MENS) ha presentato i risultati di studi clinici al 22° Congresso della Urological Association of Asia per due candidati farmaci chiave. Le sperimentazioni di Fase III per BOTRESO®, rivolte all'ipertrofia prostatica benigna (BPH), hanno mostrato un miglioramento significativo dei sintomi delle vie urinarie inferiori nelle popolazioni asiatiche e nel gruppo combinato Taiwan-USA, mentre i risultati nel sottogruppo USA non sono stati significativi. Gli studi di estensione a 52 settimane hanno evidenziato un miglioramento costante a lungo termine senza eventi avversi seri.
Inoltre, la Fase II per MCS-8 (PCP) ha raggiunto gli endpoint primari di efficacia, mostrando tassi inferiori di biopsie prostatiche positive e di tumori prostatici di alto grado rispetto al placebo dopo 104 settimane. Il mercato globale della BPH è previsto raggiungere 9,8 miliardi di dollari entro il 2026, rispetto ai 4,1 miliardi del 2020. Jyong Biotech mantiene copertura brevettuale globale e sta cercando partner internazionali per l'ingresso sul mercato.
Jyong Biotech (NASDAQ:MENS) presentó resultados de ensayos clínicos en el 22.º Congreso de la Urological Association of Asia para dos candidatos farmacéuticos clave. Los ensayos de fase III de BOTRESO®, dirigidos a la hiperplasia prostática benigna (BPH), mostraron una mejora significativa de los síntomas del tracto urinario inferior en las poblaciones asiáticas y en el grupo combinado Taiwán-EE. UU., aunque los resultados en el subgrupo de EE. UU. no fueron significativos. Los estudios de extensión de 52 semanas demostraron una mejora sostenida a largo plazo sin acontecimientos adversos graves.
Además, su ensayo de fase II de MCS-8 (PCP) alcanzó los criterios de eficacia primarios, mostrando tasas inferiores de biopsias prostáticas positivas y de cáncer de próstata de alto grado frente a placebo tras 104 semanas. Se proyecta que el mercado global de BPH alcance 9,8 mil millones de dólares para 2026, frente a 4,1 mil millones en 2020. Jyong Biotech mantiene protección por patentes a nivel mundial y busca asociaciones internacionales para entrar en el mercado.
Jyong Biotech (NASDAQ:MENS)는 아시아 비뇨기과 학회 제22차 총회에서 두 개의 주요 신약 후보에 대한 임상시험 결과를 발표했습니다. 양성 전립선 비대증(BPH)을 표적으로 한 BOTRESO®의 3상 시험은 아시아 및 대만-미국 통합 집단에서 하부 요로 증상에서 유의한 개선을 보였으나, 미국 하위집단에서는 유의하지 않았습니다. 52주 연장 연구에서는 중대한 이상반응 없이 장기적으로 일관된 개선이 확인되었습니다.
또한 MCS-8 (PCP)의 2상 시험은 주요 유효성 지표를 충족했으며, 104주 후 위약 대비 양성 전립선 생검률 및 고등급 전립선암 비율이 더 낮게 나타났습니다. 글로벌 BPH 시장은 2020년 41억 달러에서 2026년 98억 달러로 성장할 것으로 전망됩니다. Jyong Biotech는 글로벌 특허를 보유하고 있으며 시장 진입을 위한 국제 파트너십을 추진 중입니다.
Jyong Biotech (NASDAQ:MENS) a présenté des résultats d'essais cliniques lors du 22e Congrès de l'Urological Association of Asia pour deux candidats médicaments majeurs. Les essais de phase III de BOTRESO®, destiné à l'hyperplasie bénigne de la prostate (HBP), ont montré une amélioration significative des symptômes des voies urinaires basses dans les populations asiatiques et dans le groupe combiné Taïwan‑États‑Unis, tandis que les résultats du sous-groupe américain n'étaient pas significatifs. Les études d'extension sur 52 semaines ont démontré une amélioration soutenue à long terme sans événements indésirables graves.
Par ailleurs, l'essai de phase II de MCS-8 (PCP) a atteint ses critères d'efficacité primaires, montrant des taux plus faibles de biopsies prostatiques positives et de cancers de la prostate de haut grade par rapport au placebo après 104 semaines. Le marché mondial de l'HBP devrait atteindre 9,8 milliards de dollars d'ici 2026, contre 4,1 milliards en 2020. Jyong Biotech dispose d'une couverture brevetaire mondiale et recherche des partenariats internationaux pour l'accès au marché.
Jyong Biotech (NASDAQ:MENS) stellte auf dem 22. Kongress der Urological Association of Asia klinische Studienergebnisse für zwei wichtige Arzneimittelkandidaten vor. Die Phase-III-Studien zu BOTRESO®, das auf benigne Prostatahyperplasie (BPH) abzielt, zeigten eine signifikante Verbesserung der unteren Harnwegsymptome in den asiatischen und in der gepoolten Taiwan‑USA-Population, während die Ergebnisse der US-Subgruppe nicht signifikant waren. Die 52-wöchigen Verlängerungsstudien zeigten konsistente langfristige Verbesserungen ohne schwerwiegende unerwünschte Ereignisse.
Zusätzlich erfüllte die Phase-II-Studie zu MCS-8 (PCP) die primären Wirksamkeitsendpunkte und zeigte nach 104 Wochen niedrigere Raten positiver Prostatabiopsien und von hochgradigem Prostatakrebs im Vergleich zu Placebo. Der globale BPH‑Markt wird voraussichtlich 9,8 Milliarden US-Dollar bis 2026 erreichen, gegenüber 4,1 Milliarden im Jahr 2020. Jyong Biotech verfügt über weltweiten Patentschutz und strebt internationale Partnerschaften für den Markteintritt an.
- BOTRESO® showed statistically significant improvement in Asian and pooled Taiwan-U.S. populations
- Phase II trial of MCS-8 demonstrated lower rates of prostate cancer with no serious adverse events
- BOTRESO® showed excellent safety profile with no serious adverse events in 52-week studies
- Global BPH market expected to grow significantly to $9.8B by 2026
- Company has secured global patent coverage and multiple licensing agreements
- BOTRESO® failed to show significant difference in U.S. subgroup
- Large-scale Phase III trials still needed for MCS-8, requiring thousands of participants
Insights
Jyong Biotech's BPH drug shows mixed efficacy across populations but strong safety profile; prostate cancer prevention candidate advances to Phase III.
Jyong Biotech's presentation at the Urological Association of Asia Congress revealed mixed efficacy results for BOTRESO in treating benign prostatic hyperplasia (BPH). While the drug failed to show statistical significance in the U.S. subgroup, it demonstrated significant improvement in the Asian (Taiwan) subgroup and in the pooled Taiwan-U.S. population data. The 52-week extension studies confirmed long-term safety and sustained efficacy with no serious adverse events, positioning BOTRESO favorably against current treatments like α-blockers and 5-α-reductase inhibitors that carry cardiovascular and prostate cancer risks.
The Phase II results for MCS-8 (PCP) represent a more unambiguous success, meeting the primary efficacy endpoint with lower rates of positive prostate biopsies and high-grade prostate cancer compared to placebo over 104 weeks, with no treatment-related serious adverse events. This provides sufficient evidence to advance to Phase III evaluation, potentially establishing a new preventative approach in prostate cancer management.
The market context is compelling - the global BPH patient population has grown from 88.4 million in 2017 to 94.2 million in 2020, with the drug market projected to reach
The clinical data presented by Jyong Biotech represents a strategic market opportunity within the rapidly growing BPH treatment landscape. The
The drug's primary competitive advantage appears to be its safety profile. While existing treatments (α-blockers and 5-α-reductase inhibitors) carry documented cardiovascular risks and potential associations with high-grade prostate cancer, BOTRESO demonstrated consistent safety across all trials. This differentiation could be particularly valuable for long-term treatment of the chronic BPH condition, especially for patients with comorbidities.
The company's patent protection across major markets (Asia, Americas, EU) combined with their business development activities (letters of intent and licensing agreements) indicate a licensing-based commercialization model rather than building internal sales infrastructure. This approach aligns with the company's size and resource constraints while potentially accelerating market entry through established distribution channels.
The advancement of MCS-8 for prostate cancer prevention represents a significant pipeline expansion beyond BPH treatment. The pursuit of global pharmaceutical partners for Phase III trials demonstrates appropriate scale-up strategy for a prevention indication that will require large participant numbers and substantial resources. This dual-product approach addressing related urological conditions creates potential synergies in regulatory approach, clinical development, and eventual marketing.
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
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.
For more information, please contact:
Investor Relations
WFS Investor Relations Inc.
Janice Wang
Email: services@wealthfsllc.com
Phone:+1 628 283 9214
FAQ
What were the key results of Jyong Biotech's (MENS) BOTRESO Phase III trials?
How did Jyong Biotech's (MENS) MCS-8 perform in Phase II trials?
What is the market potential for Jyong Biotech's (MENS) BPH treatments?
What advantages does BOTRESO have over existing BPH treatments?
What are Jyong Biotech's (MENS) next steps for BOTRESO and MCS-8?
