Jyong Biotech Ltd. (Nasdaq stock code: MENS) (hereinafter referred to as “the Company” or “Jyong Biotech”) is a science-driven biotechnology company dedicated to developing and commercializing innovative plant-based therapies. The Company recently announced that, following an analysis of the clinical efficacy and competitive advantages of its innovative botanical drugs Botreso® and PCP, it has advanced its market access strategy.

As previously announced by the company, its first core product, Botreso®, has completed four Phase III clinical trials (API-1) in the United States and Taiwan, while its second core product, PCP, has successfully completed a Phase II clinical trial. Overall clinical data demonstrate that Jyong Biotech’s innovative botanical drugs exhibit significant differentiation advantages compared to currently marketed synthetic chemical drugs.

Overall Safety Profile for Long-Term Use

For middle-aged and elderly males requiring long-term medication, safety is one of the most decisive factors. In clinical trials—Botreso® (Phase III) had a treatment duration of one year, while PCP (Phase II) lasted two years—no drug-related serious adverse events were observed, demonstrating excellent safety and tolerability.

In contrast, currently available chemically synthesized drugs for the treatment of benign prostatic hyperplasia (BPH) are often associated with adverse effects such as postural hypotension, erectile dysfunction, and decreased libido. Regulatory authorities and research institutions have linked certain synthetic alternative medications to significant risks, prompting the U.S. Food and Drug Administration (FDA) to issue a safety advisory regarding advanced prostate cancer and depression in 2011, and to include suicidal ideation in its list of adverse reactions in 2022. Additionally, an independent study conducted in 2021 also established associations between these drugs and cardiac failure.

Management of risks associated with advanced prostate cancer

Large-scale international clinical trials have demonstrated that while certain synthetic drugs used to treat benign prostatic hyperplasia (BPH) can reduce the overall incidence of prostate cancer, they may paradoxically increase the proportion of advanced prostate cancer (Grisson score ≥ 7) when cancer develops, thereby posing significant clinical safety concerns.

The Phase II clinical trial of PCP was a large-scale, long-term study on rare conditions conducted in Taiwan across 20 major hospitals. Over a period of two years, the trial involved 135 urologists (representing more than one-tenth of all urologists in Taiwan) and enrolled a total of 702 participants. It was one of the first global clinical trials specifically targeting prostate cancer prevention using a novel botanical drug conducted in Taiwan. The results demonstrated that PCP exhibited a downward trend in both overall prostate cancer incidence and the risk of advanced-stage prostate cancer, effectively addressing concerns within the medical community regarding the risks associated with existing therapies.

Comprehensive approach of “Treatment + Prevention + Metabolic Management”

Based on the clinical data from the company’s conducted trials, the company believes it is establishing a differentiated product positioning.

• Improvement of lower urinary tract symptoms (LUTS): Effectively alleviates symptoms associated with benign prostatic hyperplasia.

• Prevention of prostate cancer: Demonstrates prophylactic clinical potential.

• Metabolic and cardiovascular protection: Decreased triglyceride levels (P=0.05), significantly reduced total cholesterol and low-density lipoprotein (bad cholesterol) (P<0.05), significantly increased high-density lipoprotein (good cholesterol) (P<0.05), and maintained stable blood glucose levels.

This comprehensive therapy delivers benefits without adversely affecting blood pressure, liver function, or renal function. The company emphasizes that this integrated approach combining treatment, prevention, and metabolic management is exceptionally rare among current prostate medications and holds significant appeal for men aged 40 and above.

Technical Barriers and Competitive Advantages

Due to the inherent complexity and diversity of components in novel botanical drugs, quality control poses greater challenges compared to that of small-molecule chemical drugs. Jianyong Biotechnology asserts that the company has successfully established a comprehensive technical platform, which includes:

• Purification and establishment of reference standards.

• Development and validation of analytical methods.

• Perform the validation analysis and verification process.

The company believes that such comprehensive capabilities create substantial market entry barriers, rendering the products highly difficult to replicate. Furthermore, they effectively mitigate risks associated with competition from counterfeit and substandard products as well as generic drugs, ultimately contributing to an extended period of market monopoly.

The upgraded market positioning and strategic value

As a plant-based new drug protected by global patents, Jyong Biotech believes its market strategy leverages the following key advantages:

• Pricing competitiveness: Its unique metabolic protection profile and safety profile enable it to command higher prices compared to non-patented generic drugs, making it attractive to both out-of-pocket and high-end healthcare markets.

• Authorization potential: The combination of high tolerability, excellent safety profile (no serious adverse reactions), and multiple clinical benefits makes it an ideal target for international pharmaceutical collaboration.

• Market scalability: Expanding the product portfolio from treatment-oriented approaches to the fields of preventive medicine and health management.

Globally, over 500 million men aged 50 and above seek treatment for benign prostatic hyperplasia (BPH). In 2020, the global BPH drug market was valued at $4.1 billion and is projected to reach $9.8 billion by 2026. Although the current treatment market generates annual revenues of approximately $6.5 to $7 billion, this figure reflects price reductions due to patent expiration. If calculated based on prices during the patent period, the market potential exceeds $20 billion annually.

“Due to the complex composition of botanical new drugs, they face significant challenges in quality control compared to small-molecule chemical drugs,” stated Chairman Guo of Jianyong Biotechnology. “We have established a robust technical platform that encompasses the purification of reference standards, development and validation of analytical methods, as well as performance validation analyses. This high entry barrier makes counterfeiting difficult to achieve, reduces competition from generic drugs, and helps extend market exclusivity periods.”

Chairman Guo stated: “Botreso® is Taiwan’s first oral botanical drug to obtain an IND approval from the U.S. FDA for Phase III clinical trials (API-1) and has successfully completed all four Phase III clinical trials.”

Jyong Biotech holds multiple invention patents across Asia, the Americas, and the European Union, and has signed letters of intent and investment agreements with several international pharmaceutical companies. The company plans to further expand its strategic, fee-based licensing partnerships to support its global market expansion.

As of today, Botreso® and PCP remain in the investigational new drug candidate stage and have not yet 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 significant progress.

Company Profile: Jyong Biotech Ltd., headquartered in Taiwan, is a science-driven biotechnology company dedicated to the research, development, and commercialization of innovative and differentiated novel drugs (of plant origin), with a primary focus on the treatment of urinary system disorders, initially targeting the markets in the United States, the European Union, and Asia. Since its establishment in 2002, the company has developed comprehensive capabilities encompassing all critical stages of drug development, including early-stage drug discovery and development, pharmacology, toxicology, clinical trials, regulatory affairs, manufacturing, and commercialization. Leveraging robust R&D capabilities and proprietary platforms, the company has developed a portfolio of plant-derived candidate drugs, including its lead plant-based candidate Botreso®, another plant-based candidate drug in clinical development, and several other plant-based candidates in preclinical stages. The company is committed to developing and delivering cutting-edge innovative therapeutics to address customer health needs and strives to become a respected and valuable enterprise.

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