Jyong Biotech Subsidiary Announces Phase II Clinical Data on Cholesterol and LDH Indicators for MCS-8 (PCP), Indicating Potential in Prostate Cancer Prevention and Metabolic Value

Rhea-AI Summary

Jyong Biotech (Nasdaq: MENS) reported updated Phase II clinical biomarker analyses for MCS-8 (PCP) in Taiwan showing multiple potentially material findings after two years of treatment. Key outcomes: total cholesterol fell significantly (P=0.036), placebo LDH rose (P=0.024) while MCS-8 did not, and prior efficacy showed 27.3% reduction in overall prostate cancer incidence versus placebo.

The company highlights favorable safety and tolerability over two years and is evaluating expanded indications into lipid management, atherosclerosis, and cardiovascular disease to broaden commercial potential.

Positive

• Overall prostate cancer incidence reduced by 27.3% versus placebo
• High-grade prostate cancer (Gleason ≥7) incidence reduced by 17.1%
• Statistically significant reduction in total cholesterol (P=0.036)
• No LDH increase in MCS-8 group versus placebo (placebo P=0.024)
• Two-year safety: no MCS-8–related serious adverse events observed

Negative

• Findings remain from an investigational Phase II trial, not regulatory approvals
• LDH and cholesterol results are secondary biomarker analyses, requiring confirmation

Key Figures

Cholesterol p-value: P = 0.036 LDH placebo p-value: P = 0.024 Prostate cancer reduction: 27.3% reduction +5 more

8 metrics

Cholesterol p-value P = 0.036 Reduction in total cholesterol after two years of MCS-8 treatment

LDH placebo p-value P = 0.024 Increase in serum LDH levels in placebo group

Prostate cancer reduction 27.3% reduction Overall prostate cancer incidence vs. placebo in Phase II

High-grade cancer reduction 17.1% reduction High-grade prostate cancer (Gleason ≥7) vs. placebo

Positive cores reduction 35.2% reduction Percentage of positive cores at diagnosis vs. placebo

Cancer-positive area reduction 24.4% reduction Cancer-positive area in positive cores vs. placebo

Treatment duration 2 years MCS-8 administration period in Phase II trial

Net loss $1,252k Six months ended June 30, 2025 (unaudited)

Market Reality Check

Price: $2.36 Vol: Volume 502,155 is 4% abov...

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$2.36 Last Close

Volume Volume 502,155 is 4% above the 20-day average of 481,444, indicating only modestly elevated trading before this update. normal

Technical Shares at $2.56 are 96.18% below the 52-week high and 3.64% above the 52-week low, trading below the 200-day MA at $30.16.

Peers on Argus

Biotech peers show mixed, mostly small moves (e.g., CRSP +0.6%, MRUS -7.08%), an...

Biotech peers show mixed, mostly small moves (e.g., CRSP +0.6%, MRUS -7.08%), and no names appeared in the momentum scanner, suggesting this update is stock-specific rather than a sector rotation.

Previous Clinical trial Reports

3 past events · Latest: Nov 20 (Positive)

Same Type Pattern 3 events

Date	Event	Sentiment	Move	Catalyst
Nov 20	Phase II analysis	Positive	+12.4%	Primary endpoint analysis showed reduced prostate cancer incidence and solid safety.
Sep 16	Enrollment complete	Positive	+5.0%	Completed enrollment of >700 high-risk subjects for MCS‑8 Phase II trial.
Aug 22	Data presentation	Positive	+6.6%	Presented Phase III BOTRESO and Phase II MCS‑8 data with efficacy and safety signals.

Pattern Detected

Clinical-trial news for MCS-8 and BOTRESO has consistently led to positive price reactions, indicating a history of favorable market response to trial milestones.

Recent Company History

Over the past months, Jyong Biotech has repeatedly highlighted progress in its clinical programs. Prior MCS‑8 Phase II updates, including completion of enrollment and positive primary endpoint analysis, produced price gains of 5.02%, 6.58%, and 12.44%. These events emphasized reduced prostate cancer incidence, improved lipid profiles, and solid safety. Today’s announcement extends the same Phase II dataset with additional cholesterol and LDH biomarker data, reinforcing earlier efficacy and safety signals rather than introducing a new trial stage.

Historical Comparison

clinical trial

+8.0 %

Average Historical Move

Historical Analysis

Clinical-trial headlines for MCS-8 and BOTRESO have produced an average move of 8.01%, showing that prior trial updates have been meaningful trading catalysts.

Typical Pattern

Recent clinical news traces MCS‑8’s Phase II journey from enrollment completion through positive primary endpoint analysis, with today’s release adding deeper biomarker and metabolic context to the same study.

Market Pulse Summary

This announcement extends prior Phase II results for MCS‑8 by detailing statistically significant ef...

Analysis

This announcement extends prior Phase II results for MCS‑8 by detailing statistically significant effects on total cholesterol and LDH, while reiterating reductions of 27.3% in overall and 17.1% in high‑grade prostate cancer incidence versus placebo. Combined with a two‑year safety profile showing no increase in adverse events, the data strengthen the candidate’s preventive and metabolic story. Historically, clinical‑trial milestones for MCS‑8 and BOTRESO have been important fundamental markers for Jyong Biotech’s development path.

Key Terms

phase ii clinical trial, lactate dehydrogenase (ldh), ldh, placebo, +4 more

8 terms

phase ii clinical trial medical

"updated statistical analyses for key blood biochemical markers from its Phase II clinical trial of MCS-8"

A Phase II clinical trial is a mid-stage study in humans that tests whether an experimental drug or treatment actually works and what dose is effective, typically involving dozens to a few hundred patients and often comparing outcomes to a placebo or standard care. For investors, Phase II results are a major inflection point: clear positive data can substantially increase the odds of later regulatory approval and company value, while negative or uncertain results raise development risk and can sharply reduce expectations—like a detailed test drive after basic safety checks.

lactate dehydrogenase (ldh) medical

"new value in metabolic indicators, specifically cholesterol and lactate dehydrogenase (LDH)."

Lactate dehydrogenase (LDH) is an enzyme found throughout the body that helps cells convert sugar into energy and is released into the blood when tissues are stressed or damaged. Investors watch LDH levels because they act like a simple gauge—similar to a car’s warning light—indicating disease activity, organ injury, or treatment effects; unexpected changes can affect a drug’s safety profile, clinical trial readouts, or the perceived health of a company’s assets.

ldh medical

"A statistically significant increase in serum lactate dehydrogenase (LDH) levels observed in the placebo group"

LDH stands for lactate dehydrogenase, an enzyme found throughout the body that is released into the blood when cells are damaged or rapidly turn over. Investors watch LDH levels reported in clinical data because rising or falling values can indicate disease severity, treatment effect, or safety concerns—much like an engine temperature gauge, it gives a quick, general signal about patient health that can influence a therapy’s commercial prospects.

placebo medical

"A statistically significant increase in serum lactate dehydrogenase (LDH) levels observed in the placebo group"

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

gleason score medical

"incidence of high-grade prostate cancer (Total Gleason Score ≥ 7) was reduced by 17.1%"

A Gleason score is a number assigned by a pathologist after examining prostate tissue under a microscope to describe how much the cancer cells differ from normal cells and how likely the tumor is to grow and spread. Think of it as a heat‑map rating for aggressiveness: higher scores mean more aggressive disease and a greater need for intensive treatment. For investors, Gleason scores influence expected patient outcomes, treatment choices, and the market size and urgency for related diagnostics and therapies.

adverse events medical

"did not increase the rate of adverse events. No serious adverse events related to MCS-8"

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 medical

"core patented pharmaceutical composition technology, which Company believes significantly enhances bioavailability"

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.

investigational new drug regulatory

"MCS-8 remains an investigational new drug candidate and has not been approved"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

AI-generated analysis. Not financial advice.

New Taipei City, Taiwan, Jan. 30, 2026 (GLOBE NEWSWIRE) -- Jyong Biotech Ltd. (Nasdaq: MENS) (the “Company” or “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 updated statistical analyses for key blood biochemical markers from its Phase II clinical trial of MCS-8 (PCP) conducted in Taiwan. The results underscore MCS-8’s previously indicated multifaceted clinical and commercial potential beyond its clinical evidence in prostate cancer prevention, showing its potential in helping alleviate high-grade malignancy risk. The data reveals significant new value in metabolic indicators, specifically cholesterol and lactate dehydrogenase (LDH). Building on this momentum, the Company is evaluating the feasibility of expanding MCS-8’s indications to include lipid management, atherosclerosis, and cardiovascular diseases—a strategic move aimed at extending the product’s lifecycle and significantly capturing a broader market share.

The Phase II clinical trial demonstrated that after two years of treatment, subjects receiving MCS-8 showed improved lipid control compared with baseline, including:

• A statistically significant reduction in total cholesterol levels (P = 0.036);
• A statistically significant increase in serum lactate dehydrogenase (LDH) levels observed in the placebo group (P = 0.024), while no such increase was observed in the MCS-8 group.
  
  

LDH is an enzyme widely present in organs and tissues throughout the body, and elevated serum LDH levels are commonly associated with cellular damage or cell death. The absence of LDH elevation in the MCS-8 group suggests that MCS-8 may not be causing damage or death to the cell.

As previously disclosed, the primary efficacy endpoint of the Phase II study showed that, compared with placebo, the MCS-8 group demonstrated a 27.3% reduction in overall prostate cancer incidence. In addition, the incidence of high-grade prostate cancer (Total Gleason Score ≥ 7) was reduced by 17.1% compared with placebo. Further pathological analyses demonstrated favorable trends, including a 35.2% reduction in the percentage of positive cores involved at diagnosis and a 24.4% reduction in the percentage of cancer-positive area involved in positive cores, compared with placebo, suggesting improved control of disease progression. Safety data from the previously disclosed analyses showed that long-term administration of MCS-8 for two years did not increase the rate of adverse events. No serious adverse events related to MCS-8 were observed, and no negative effects were identified on liver function, kidney function, or blood pressure. Company believes that the favorable tolerability profile supports the potential suitability of MCS-8 for long-term preventive use.

MCS-8 is developed using Jyong Biotech’s core patented pharmaceutical composition technology, which Company believes significantly enhances bioavailability and improves physiological efficacy, offering substantial potential for the development of multiple dosage forms and indications.

Related research findings have been published in the international journal Nanotechnology and included by Global Medical Discovery institutions in Canada.

MCS-8 remains an investigational new drug candidate and has not been approved for commercial use in any jurisdiction.

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 did Jyong Biotech (MENS) report about MCS-8 Phase II cholesterol results on January 30, 2026?

MCS-8 showed a statistically significant reduction in total cholesterol after two years (P=0.036). According to the company, this metabolic signal suggests potential for lipid management and related indications pending confirmatory studies.

How did MCS-8 affect LDH levels in the Phase II trial reported by Jyong Biotech (MENS)?

Placebo subjects had a significant LDH increase (P=0.024) while MCS-8 subjects did not show LDH elevation. According to the company, the absence of LDH rise in the MCS-8 arm may indicate no treatment-related cellular damage.

What were the prostate cancer efficacy outcomes for MCS-8 in Jyong Biotech's Phase II trial (MENS)?

MCS-8 reduced overall prostate cancer incidence by 27.3% versus placebo and high-grade cases by 17.1%. According to the company, additional pathology measures also trended favorably for disease progression control.

Does the Phase II data change MCS-8's regulatory or commercial status for Jyong Biotech (MENS)?

No—MCS-8 remains an investigational new drug and is not approved for commercial use. According to the company, the data support feasibility studies for expanded indications but require confirmatory trials and regulatory review.

What safety signals did Jyong Biotech (MENS) report for two-year MCS-8 administration?

Long-term use for two years did not increase adverse event rates or show liver, kidney, or blood pressure harms. According to the company, no serious adverse events were attributed to MCS-8 and tolerability supports potential preventive use.