Jyong Biotech Updates the Potential Clinical Benefits and Advantages of Its Plant-Derived Innovative Drug MCS®-2

Rhea-AI Summary

Jyong Biotech (Nasdaq: MENS) updated clinical and IP highlights for its plant-derived drug MCS®-2, developed for BPH/LUTS. MCS®-2 completed four Phase III trials (U.S. and Taiwan) with reported excellent safety and no serious adverse events, and the company cites global patent protection enabling multiple formulations.

The candidate remains investigational and is not approved for commercial use; Jyong Biotech says it will provide regulatory updates as material developments occur.

Positive

• Completed four Phase III trials across U.S. and Taiwan
• Reported excellent safety with no serious adverse events across Phase III trials
• Global patent portfolio covering formulations and routes (oral, injectable, instillation)
• Extensive physician network involvement—200+ U.S. urologists and 70+ Taiwanese urologists

Negative

• Not approved—MCS®-2 remains an investigational new drug and is not commercially authorized
• No efficacy metrics disclosed in the update (no effect sizes, responder rates, or p-values)

Key Figures

Phase III trials: 4 Phase III trials Pivotal trials: 2 pivotal trials Open-label extensions: 2 open-label extension studies +5 more

8 metrics

Phase III trials 4 Phase III trials MCS-2 (API-1) in U.S. and Taiwan

Pivotal trials 2 pivotal trials One in U.S., one in Taiwan

Open-label extensions 2 open-label extension studies One in U.S., one in Taiwan

U.S. trial centers 27 centers U.S. Phase III trials

U.S. states 19 states Geographic spread of U.S. trials

U.S. urologists over 200 urologists Participating physicians in U.S. trials

Taiwan hospitals 12 major hospitals Trial sites in Taiwan

Taiwan urologists more than 70 urologists Participating physicians in Taiwan trials

Market Reality Check

Price: $2.02 Vol: Volume 39,010 is well bel...

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$2.02 Last Close

Volume Volume 39,010 is well below the 20-day average of 218,748 (relative volume 0.18). low

Technical Shares at $2.02 are trading below the $24.53 200-day moving average and 96.99% under the 52-week high.

Peers on Argus

MENS fell 3.35% while several biotech peers like CRSP (+2.41%), PTCT (+1.75%), T...

MENS fell 3.35% while several biotech peers like CRSP (+2.41%), PTCT (+1.75%), TGTX (+1.49%) and RNA (+0.85%) rose, with MRUS down 7.08%, suggesting stock-specific trading rather than a broad sector move.

Historical Context

5 past events · Latest: Feb 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 12	Phase II data MCS-8	Positive	+0.7%	Phase II data for MCS-8 showing prostate cancer and metabolic benefits.
Jan 30	Biomarker update MCS-8	Positive	-7.8%	Updated Phase II biomarker analyses with statistically significant cholesterol and LDH effects.
Dec 19	Share volatility response	Neutral	-4.7%	Company response to volatility after lock-up expiry and recap of API-1 clinical work.
Dec 04	Vietnam MCS-2 MOU	Neutral	-0.2%	Non-binding MOU with Vietnam distributor to evaluate MCS-2 commercialization.
Nov 24	Korea in-licensing LOI	Positive	+15.2%	Non-binding LOI with South Korean pharma to evaluate in-licensing MCS-2.

Pattern Detected

News on partnerships and clinical progress has produced mixed reactions, with one notable selloff on positive Phase II data.

Recent Company History

Over the last several months, Jyong Biotech has highlighted progress across its MCS platform. In November–December 2025, it announced non-binding LOIs and an MOU for MCS-2 in South Korea and Vietnam, plus a response to volatility tied to a December 2025 lock-up expiry. In early 2026, the focus shifted to MCS-8 Phase II data, showing reductions in prostate cancer incidence and favorable metabolic biomarkers. Today’s MCS-2 update reinforces the broader narrative of late-stage, plant-derived prostate therapeutics and ongoing globalization efforts.

Market Pulse Summary

This announcement highlights the advanced clinical status of MCS-2, including four Phase III trials ...

Analysis

This announcement highlights the advanced clinical status of MCS-2, including four Phase III trials and broad physician participation across U.S. and Taiwanese centers, with no serious adverse events reported. It reinforces Jyong Biotech’s strategy of plant-derived therapeutics in prostate and urinary conditions. Investors may track future regulatory milestones, any shift from investigational status, progress on prior LOIs and MOUs, and updates to financial resources disclosed in recent 6-K filings as key signals for the development trajectory.

Key Terms

benign prostatic hyperplasia, lower urinary tract symptoms, Phase III clinical trial, toxicology studies, +3 more

7 terms

benign prostatic hyperplasia medical

"potential clinical benefits in the treatment of benign prostatic hyperplasia/lower urinary tract"

Benign prostatic hyperplasia is a noncancerous enlargement of the prostate gland that can squeeze the urethra and cause urinary symptoms like weak stream, urgency, and incomplete emptying; think of it as a garden hose being pinched so water flow slows. It matters to investors because it creates steady demand for medications, medical devices and procedures, regulatory approvals, and insurance coverage decisions—factors that can drive revenue and growth in healthcare companies serving an aging population.

lower urinary tract symptoms medical

"treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS)"

Lower urinary tract symptoms are a group of problems affecting bladder and urethra function, such as frequent urination, urgent need to go, weak stream, dribbling, or trouble starting and stopping. For investors, these symptoms matter because they drive demand for medicines, medical devices and care services; treating them can be a steady source of revenue much like recurring maintenance for a household appliance that needs ongoing fixes or upgrades.

Phase III clinical trial medical

"only oral botanical new drug to have completed a global Phase III clinical trial for"

A phase iii clinical trial is the late-stage study where a new drug or medical treatment is tested in large groups of patients to confirm effectiveness, monitor side effects, and compare it to current standard care. For investors, successful results are a major milestone because they greatly increase the chance of regulatory approval and market access, similar to a final test flight that clears a new airplane for commercial service.

toxicology studies medical

"Phase I through Phase III clinical validation, along with more than ten international toxicology studies."

Toxicology studies are safety tests that measure whether a drug, chemical or product can cause harm to people, animals or the environment, often using cells, animals or lab models to spot toxic effects and safe dose ranges. Investors care because these results influence regulatory approval, development costs, timelines and legal risk—much like crash tests signal whether a car is safe to sell and how much fixing or redesign it might require before hitting the market.

adverse events medical

"the drug demonstrated excellent safety, with no serious adverse events, supporting its suitability"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

bioavailability technical

"core technology significantly enhances bioavailability and enables the development of multiple formulations"

Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.

FDA regulatory

"Jyong Biotech strictly adheres to FDA guidelines and standards throughout its drug development"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. Not financial advice.

New Taipei City, Taiwan, March 27, 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 provided an update on the plant-derived innovative drug MCS^®-2 of its multiple competitive advantages and its potential clinical benefits in the treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS).

• Pioneering Plant-Based Therapeutics
  Developed in Taiwan, MCS^®-2 is the world’s only oral botanical new drug to have completed a global Phase III clinical trial for benign prostatic hyperplasia (BPH). Jyong Biotech has conducted four Phase III clinical trials (API-1) in the U.S. and Taiwan, including two pivotal trials (one in the U.S. and one in Taiwan) and two open-label extension studies (one in the U.S. and one in Taiwan), and completion of the Phase III clinical trial report was achieved in 2017.
  

In the U.S., trials were conducted across 27 centers in 19 states, involving over 200 urologists. In Taiwan, trials took place in 12 major hospitals, including multiple medical centers, with participation from more than 70 urologists (over one-tenth of all urologists in Taiwan). The Company believes that this extensive physician network lays a strong foundation for future commercialization and expansion into new indications.

• Rigorous Scientific Validation and Clinical Evidence:
  Jyong Biotech strictly adheres to FDA guidelines and standards throughout its drug development process. MCS^®-2 (API-1) has completed Phase I through Phase III clinical validation, along with more than ten international toxicology studies. Across all four Phase III trials in Taiwan and the U.S., the drug demonstrated excellent safety, with no serious adverse events, supporting its suitability for long-term use.
• Global Patent Protection:
  The company believes that its core technology significantly enhances bioavailability and enables the development of multiple formulations and indications, including oral formulations, injectable forms, and bladder instillation therapies. These innovations are protected by patents across the Americas, Asia, Europe, and other regions, forming a global portfolio that effectively overcomes existing patent barriers established by major pharmaceutical companies.
• Large Market Potential for Target Indications:
  BPH/LUTS is a common age-related condition affecting hundreds of millions of men worldwide.
  

Current treatments for BPH/LUTS are associated with side effects and drug resistance, impacting patient compliance and satisfaction. There is therefore an urgent unmet need for a safe, long-term therapeutic solution. MCS^®-2 is being developed to address this gap, offering clear competitive advantages.

The Company believes that with global population aging and increasing healthcare demand, the market for prostate disease treatment and prevention presents substantial growth potential. Jyong Biotech remains committed to advancing innovative R&D to provide safer, evidence-based solutions.

Since its establishment, Jyong Biotech has remained committed to innovation and R&D, continuously expanding its scope and vision. The company places strong emphasis on quality and regulatory compliance, strictly adhering to international standards to ensure the safety and quality of its products. Through these efforts, Jyong Biotech believes that it is well-positioned to enter global markets, promote cross-border collaborations and licensing models, and create broader opportunities for partnerships worldwide.

“We are proud to lead the development of Taiwan’s first oral botanical new drug to advance into Phase III clinical trials,” stated Fu-Feng Kuo, Chairwoman and CEO of Jyong Biotech. “MCS^®-2 reflects our commitment to innovation and has the potential to provide safer, long-term solutions for patients with BPH/LUTS. We look forward to expanding our global impact through continued research and development.”

As of present day, MCS-2 remains an investigational new drug candidate and has 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@wealthfsllc.com
Phone: +1 628 283 9214

FAQ

What clinical progress has Jyong Biotech (MENS) reported for MCS®-2 as of March 27, 2026?

MCS®-2 has completed four Phase III trials in the U.S. and Taiwan with reported safety results. According to the company, trials included two pivotal Phase III studies and two open-label extensions, with a Phase III clinical trial report completed in 2017.

Is MCS®-2 approved for treating BPH/LUTS according to Jyong Biotech (MENS)?

No, MCS®-2 is still investigational and not approved for commercial use. According to the company, regulatory approval has not been obtained in any jurisdiction as of the announcement date.

What safety outcomes did Jyong Biotech (MENS) report for MCS®-2 in Phase III trials?

The company reported excellent safety with no serious adverse events across its Phase III trials. According to the company, this safety profile supports potential long-term use in BPH/LUTS patients.

What intellectual property protections does Jyong Biotech (MENS) claim for MCS®-2?

Jyong Biotech says it holds patents across the Americas, Asia, and Europe covering bioavailability and multiple formulations. According to the company, the portfolio enables oral, injectable, and bladder instillation development.

How large and geographically diverse were the MCS®-2 Phase III trials mentioned by Jyong Biotech (MENS)?

Trials were multi-center across 27 U.S. sites in 19 states and 12 major hospitals in Taiwan. According to the company, more than 200 U.S. urologists and 70 Taiwanese urologists participated.

What commercial potential does Jyong Biotech (MENS) attribute to MCS®-2 for prostate treatment markets?

The company positions MCS®-2 for large market demand due to aging populations and unmet safety needs in BPH/LUTS therapy. According to the company, the candidate aims to offer safer, long-term therapeutic options.