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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.

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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

News Market Reaction – MENS

+5.02%
6 alerts
+5.02% News Effect
+6.0% Peak in 1 hr 58 min
+$214M Valuation Impact
$4.47B Market Cap
0.5x Rel. Volume

On the day this news was published, MENS gained 5.02%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.0% during that session. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $214M to the company's valuation, bringing the market cap to $4.47B at that time.

Data tracked by StockTitan Argus on the day of publication.

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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Biotechnology
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Taiwan
New Taipei City