Jyong Biotech CEO Outlines FDA Pathway and Global Strategy in PharmaBoardroom Live Interview
Rhea-AI Summary
Jyong Biotech (Nasdaq:MENS) highlighted its FDA pathway and global strategy in a CEO interview. The company uses proprietary chylomicron and micelle technologies with patents in the US, EU, and Asia. Lead asset Botreso targets benign prostatic hyperplasia, supported by two pivotal and two one-year extension studies with no emergent safety signals.
To meet FDA supply-chain requirements, Jyong Biotech plans a US pharmacokinetic study and a Phase III trial comparing API-1 and API-2, aiming for a combined NDA submission around 2029–2030. A prostate cancer prevention asset has completed Phase II in Taiwan, and the US is prioritized as the first launch market. Botreso and PCP remain investigational.
Positive
- Lead BPH drug Botreso backed by two pivotal and two extension studies
- Botreso and PCP use proprietary chylomicron and micelle technologies with global patents
- Targeted combined NDA submission for Botreso in 2029–2030 timeframe
- PCP prostate cancer prevention asset has completed Phase II trial in Taiwan
- US prioritized as first market to support premium pricing and global approvals
Negative
- Additional US pharmacokinetic study and Phase III trial required before NDA submission
- Combined NDA for Botreso not targeted until 2029–2030
- Botreso and PCP remain investigational with no approvals in any jurisdiction
News Market Reaction – MENS
In the May 29 session, MENS declined 2.22%, reflecting a moderate negative market reaction. Argus tracked a trough of -2.3% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 15 | Annual report filing | Neutral | -3.4% | Form 20-F filed, detailing pre-revenue status and key risk factors. |
| Apr 28 | Market access update | Positive | +0.9% | Outlined competitive market access strategy for Botreso and PCP. |
| Mar 27 | Clinical/IP update | Positive | -4.0% | Reported Phase III data and IP strength for MCS-2 in BPH/LUTS. |
| Feb 12 | Phase II oncology data | Positive | +0.7% | Phase II MCS-8 results showing reduced prostate cancer incidence and lipids benefit. |
| Jan 30 | Biomarker analysis | Positive | -7.8% | Two-year biomarker data for MCS-8 (PCP) with cholesterol and LDH signals. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent clinically focused and strategic updates often produced modest moves, with some positive clinical news followed by negative price reactions, indicating inconsistent alignment between fundamentals and near-term trading.
Over the last few months, Jyong Biotech has highlighted clinical progress and strategic positioning across its pipeline. Updates on Botreso® and PCP’s market access and Phase III/II data (Apr 28, Feb 12, Jan 30) emphasized efficacy, safety, and metabolic benefits. However, filings and scientific updates (Mar 27, May 15) saw mixed to negative reactions. Today’s interview-driven strategy piece reinforces the same themes: long FDA timelines, API transition requirements, and a focus on U.S.-first commercialization within urology and oncology prevention.
Key Terms
benign prostatic hyperplasia medical
new drug application regulatory
pharmacokinetic medical
phase iii medical
active pharmaceutical ingredient medical
black box warnings regulatory
orthostatic hypotension medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
New Taipei City, Taiwan, May 29, 2026 (GLOBE NEWSWIRE) -- Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company” or “Jyong Biotech”), a science-driven biotechnology company dedicated to the development and commercialization of innovative plant-derived therapeutics, today highlighted a strategic vision detailed by its founder and chief executive officer, Ms. Fu-Feng Kuo, in a recently published live interview with PharmaBoardroom, a UK-based platform providing global intelligence for the healthcare and life sciences industries.
In the interview, CEO Kuo described how Jyong Biotech has built its scientific foundation through a hybrid operating model, pairing its Taiwanese R&D subsidiary, Health Ever Biotech, with specialized US regulatory consultants to meet stringent FDA standards for botanical drug development, and that the Company’s solution lies in the proprietary chylomicron and micelle technologies that were developed in-house. These technologies enable exceptionally high bioavailability, and the drug candidates hold invention patents spanning the US, the European Union, and Asia.
A central focus of the interview is the Company’s lead botanical asset, Botreso®, which the Company believes is uniquely positioned to disrupt the market for benign prostatic hyperplasia (BPH). CEO Kuo detailed the compelling commercial landscape, noting there are approximately 12.2 million BPH patients in the US alone. Currently, roughly 35 percent of these patients are in "watchful waiting" without pharmacological therapy, while another 9.1 percent have discontinued treatment due to severe side-effect intolerance [source: The Canadian Journal of Urology, 2015]. Existing synthetic therapies, such as alpha-blockers and 5-alpha reductase inhibitors, carry documented adverse events of orthostatic hypotension, ejaculatory disorder, nasal congestion and so on. 5-alpha also carries an FDA-mandated black box warnings for more serious forms of prostate cancer.
Against this backdrop, Company believes that the clinical profile of Botreso® is potentially transformative. Jyong Biotech has fortified its pending New Drug Application (NDA) case, which was based on API-1, with extensive data, including two pivotal studies and two one-year open-label extension studies conducted across the US and Taiwan. These studies confirm with no emergent safety signals. To fulfill FDA requirements regarding supply chain resilience, Jyong Biotech is required to conduct a US pharmacokinetic study to demonstrate comparability between API-1 and a second active pharmaceutical ingredient source (API-2) and a Phase III trial utilizing API-2. Upon the successful completion of these studies and trails, if all goes well, the Company targets a combined NDA submission in the 2029 to 2030 timeframe.
Beyond BPH, CEO Kuo emphasized the market opportunity for preventative urological care. The Company’s Prostate Cancer Prevention (PCP) asset has completed Phase II trial in Taiwan, exhibiting the safety profile strictly required for lifelong preventative therapies. Recognizing the substantial scale of a preventative Phase III trial, Jyong Biotech is engaged in discussions with major pharmaceutical companies to co-develop and co-fund the oncology program. Furthermore, organic pipeline extensions targeting metabolic diseases are being advanced through strategic out-licensing models, allowing the Company to develop adjacent scientific discoveries without diverting resources from its core urology franchise.
Addressing Jyong Biotech’s commercial sequencing, CEO Kuo reaffirmed that the United States is the unequivocal first priority. Securing an FDA approval not only provides access to premium drug pricing but also accelerates regulatory pathways in diverse global markets, including Brazil, Israel, and broader Asia.
Reflecting on the core philosophy that has sustained the Company’s rigorous two-decade journey, CEO Kuo stated, “As an ageing global society, the demand for efficacious treatments with low side-effect profiles will only grow. The population that needs long-term chronic disease management cannot tolerate drugs that create new health burdens.” CEO Kuo also added that “The science and the commercial ambition are not in tension because they derive from the same source: an understanding that the right drug, proven to the highest standard, will ultimately find its market.”
To read the complete, in-depth interview with CEO Fu-Feng Kuo, please visit PharmaBoardroom: https://pharmaboardroom.com/interviews/fu-feng-kuo-founder-ceo-jyong-biotech/.
As of present day, Botreso® and PCP remain investigational new drug candidates and have not been approved for commercial use in any jurisdiction. Jyong Biotech will comply with applicable regulatory disclosure obligations and provide timely, accurate, and complete updates on material developments.
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, pharmacology, toxicology, 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, prospectuses, annual and interim reports, and other filings 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:
Jyong Biotech Ltd.
ir@jyongbio.com
Investor Relations
WFS Investor Relations Inc.
Email: services@wfsir.com
Phone: +1 628 283 9214
