Jyong Biotech (MENS) FDA Approvals

Jyong Biotech's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Jyong Biotech (MENS). Over the past two years, Jyong Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MCS‑8. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

MCS‑8 FDA Regulatory Events

MCS‑8 is a drug developed by Jyong Biotech for the following indication: Prostate Cancer Prevention. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Enrollment Update - September 16,2025

Phase 2

• Drug: MCS‑8
• Announced Date: September 16, 2025
• Indication: Prostate Cancer Prevention

Jyong Biotech Ltd. 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.

Jyong Biotech Ltd., a science-driven biotechnology company in Taiwan, has finished enrolling patients in its Phase II clinical trial of MCS-8, a plant-derived investigational drug for prostate cancer prevention. Since the trial began, more than 700 high-risk subjects have joined the study.

This randomized, placebo-controlled trial is taking place at 20 hospitals across Taiwan. Over 130 urologists are involved in testing MCS-8’s ability to prevent prostate tumors in men at high risk. The trial design follows strict protocols to measure safety and preliminary efficacy. The study aims to offer a new preventive therapy for men at risk.

Fu-Feng Kuo, the company’s Chairwoman and CEO, said the team exceeded expectations by reaching this milestone despite challenges from the COVID-19 pandemic. MCS-8 remains investigational and is not yet approved. After the treatment period ends, the company will analyze data and share the results as required.

Jyong Biotech FDA Events - Frequently Asked Questions

Has Jyong Biotech received FDA approval?

As of now, Jyong Biotech (MENS) has not received any FDA approvals for its therapy in the last two years.

What drugs has Jyong Biotech submitted to the FDA?

In the past two years, Jyong Biotech (MENS) has reported FDA regulatory activity for MCS‑8.

What is the most recent FDA event for Jyong Biotech?

The most recent FDA-related event for Jyong Biotech occurred on September 16, 2025, involving MCS‑8. The update was categorized as "Enrollment Update," with the company reporting: "Jyong Biotech Ltd. 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."

What conditions do Jyong Biotech's current drugs treat?

Currently, Jyong Biotech has one therapy (MCS‑8) targeting the following condition: Prostate Cancer Prevention.