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Jyong Biotech Announces Completion of Patient Enrollment of over 700 subjects in Phase II Clinical Trial of MCS‑8 for Prostate Cancer Prevention

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Jyong Biotech (NASDAQ:MENS) has announced the completion of patient enrollment in its Phase II clinical trial for MCS-8, a plant-derived investigational drug candidate for prostate cancer prevention. The trial has successfully enrolled over 700 high-risk subjects across 20 hospitals in Taiwan, involving more than 130 urologists.

The study is designed as a randomized, placebo-controlled trial. Despite COVID-19 challenges, the company has achieved this milestone ahead of schedule. The company plans to analyze the trial data after completing the treatment period and will disclose results according to applicable requirements.

Jyong Biotech (NASDAQ:MENS) ha annunciato il completamento dell'arruolamento dei pazienti nel suo trial di fase II per MCS-8, candidato farmaco sperimentale di origine vegetale per la prevenzione del cancro alla prostata. lo studio ha reclutato con successo oltre 700 soggetti ad alto rischio in 20 ospedali in Taiwan, coinvolgendo più di 130 urologi.

Lo studio è progettato come uno studio randomizzato controllato con placebo. Nonostante le sfide legate al COVID-19, l'azienda ha raggiunto questo traguardo prima della scadenza. L'azienda prevede di analizzare i dati dello studio dopo aver completato il periodo di trattamento e divulgherà i risultati secondo i requisiti applicabili.

Jyong Biotech (NASDAQ:MENS) ha anunciado la finalización del reclutamiento de pacientes en su ensayo clínico de fase II para MCS-8, candidato a fármaco en investigación de origen vegetal para la prevención del cáncer de próstata. El ensayo ha reclutado con éxito a más de 700 sujetos de alto riesgo en 20 hospitales en Taiwán, involucrando a más de 130 urólogos.

El estudio está diseñado como un ensayo aleatorizado, controlado con placebo. A pesar de los desafíos de COVID-19, la empresa ha logrado este hito antes de lo previsto. La compañía planea analizar los datos del ensayo después de completar el periodo de tratamiento y divulgará los resultados de acuerdo con los requisitos aplicables.

Jyong Biotech (NASDAQ:MENS)MCS-8에 대한 2상 임상시험의 환자 모집 완료를 발표했습니다. 이는 전립선암 예방을 위한 식물 유래의 연구용 의약품 후보입니다. 이 시험은 대만의 20개 병원에서 700명 이상 고위험 피험자를 성공적으로 모집했고 130명 이상 비뇨의학과 의사가 참여했습니다.

연구는 무작위, 위약 대조 임상로 설계되었습니다. COVID-19의 도전에도 불구하고 회사는 이 이정표를 일정보다 앞당겨 달성했습니다. 회사는 치료 기간이 종료된 후 시험 데이터를 분석할 계획이며, 해당 요구사항에 따라 결과를 공개할 예정입니다.

Jyong Biotech (NASDAQ:MENS) a annoncé l’achèvement de l’inscription des patients dans son essai clinique de phase II pour le MCS-8, candidat médicament expérimental d’origine végétale pour la prévention du cancer de la prostate. L’essai a recruté avec succès plus de 700 sujets à haut risque dans 20 hôpitaux à Taïwan, impliquant plus de 130 urologues.

L’étude est conçue comme un essai randomisé, contrôlé par placebo. Malgré les défis liés au COVID-19, l’entreprise a atteint cette étape plus tôt que prévu. Elle prévoit d’analyser les données de l’essai après la période de traitement et divulguera les résultats conformément aux exigences applicables.

Jyong Biotech (NASDAQ:MENS) hat den Abschluss der Patientenrekrutierung in seiner Phase-II-Studie für MCS-8, einen pflanzenbasierten Untersuchungsmedikamentenkandidaten zur Prävention von Prostatakrebs, angekündigt. Die Studie hat erfolgreich über 700 Hochrisikopatienten in 20 Krankenhäusern in Taiwan rekrutiert und beteiligt über 130 Urologen.

Die Studie ist als randomisierte, placebokontrollierte Studie konzipiert. Trotz der COVID-19-Herausforderungen hat das Unternehmen diesen Meilenstein vorzeitig erreicht. Das Unternehmen plant, die Studiendaten nach Abschluss der Behandlungsdauer zu analysieren und die Ergebnisse gemäß den geltenden Anforderungen offenzulegen.

Jyong Biotech (NASDAQ:MENS) أعلنت عن اكتمال تسجيل المرضى في تجربتها السريرية للمرحلة الثانية لـ MCS-8، وهو مرشح دواء بحثي مشتق من نباتات للوقاية من سرطان البروستاتا. وقد نجحت التجربة في تسجيل أكثر من 700 مريض عالي الخطورة في 20 مستشفى في تايوان، بمشاركة أكثر من 130 طبيب بوليهندسياً.

الدراسة مصممة كـ تجربة عشوائية محكومة بالدواء الوهمي. على الرغم من تحديات COVID-19، حققت الشركة هذا الإنجاز قبل الجدول المحدد. تخطط الشركة لتحليل بيانات التجربة بعد إكمال فترة العلاج وستكشف النتائج وفقاً للمتطلبات المعمول بها.

Jyong Biotech (NASDAQ:MENS) 已宣布完成其二期临床试验中对 MCS-8 的患者招募,该试验是以植物为来源的前列腺癌预防研究药物候选药。该试验已在 台湾的 20 家医院 成功招募了 超过 700 名高风险受试者,并有 超过 130 名泌尿科医师参与

该研究设计为 随机、安慰剂对照试验。尽管受新冠疫情挑战,企业仍提前实现了这一里程碑。公司计划在完成治疗期后对试验数据进行分析,并将根据适用要求披露结果。

Positive
  • Successfully enrolled over 700 high-risk subjects for Phase II trial, exceeding expectations
  • Trial progress ahead of schedule despite COVID-19 challenges
  • Large-scale study involving 20 hospitals and 130+ urologists adds credibility
Negative
  • MCS-8 remains investigational and not approved in any jurisdiction
  • No interim efficacy data or preliminary results shared

New Taipei City, Taiwan, Sept. 16, 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, today announced that it has completed patient enrollment in its Phase II clinical trial of MCS‑8, an investigational drug candidate for prostate cancer prevention (PCP), with more than 700 high-risk subject who have enrolled into this clinical trial since its commencement.

The randomized, placebo-controlled trial is being conducted across 20 hospitals in Taiwan, with the participation of more than 130 urologists.

“We are pleased to have reached this key milestone in the MCS‑8 development program,” said Fu-Feng Kuo, Chairwoman and CEO of Jyong Biotech. “We have enrolled over 700 participants in this clinical trial, and despite the challenging times of the COVID-19 pandemic, we have successfully achieved this milestone and the progress has been ahead of our expectations. This truly reflects the team's professionalism, patience, dedication, and commitment.”

MCS‑8 remains an investigational new drug candidate and has not been approved for commercial use in any jurisdiction. The Company expects to analyze the trial data following completion of the treatment period and will share results in accordance with applicable disclosure requirements.

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 is the current status of Jyong Biotech's (MENS) MCS-8 Phase II clinical trial?

Jyong Biotech has completed patient enrollment with over 700 high-risk subjects in its Phase II clinical trial for MCS-8, a prostate cancer prevention drug candidate.

How many hospitals and doctors are involved in Jyong Biotech's MCS-8 Phase II trial?

The trial is being conducted across 20 hospitals in Taiwan with participation from more than 130 urologists.

What type of drug is Jyong Biotech's (MENS) MCS-8?

MCS-8 is a plant-derived investigational drug candidate being developed for prostate cancer prevention (PCP).

When will Jyong Biotech (MENS) release the results of the MCS-8 Phase II trial?

The company will analyze the trial data after completing the treatment period and will share results in accordance with applicable disclosure requirements. No specific date has been announced.

Is MCS-8 approved for commercial use?

No, MCS-8 remains an investigational new drug candidate and has not been approved for commercial use in any jurisdiction.
Jyong Biotech Ltd.

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