As previously announced, 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 its Phase II clinical trial. Overall clinical data indicates that Jyong Biotech's innovative botanical drugs demonstrate significant differentiated advantages over currently prescribed synthetic chemical drugs.

Safety Profile for Long-Term Use

For middle-aged and elderly men requiring long-term medication, safety is one of the most decisive factor. During the clinical trials – a one-year medication period for Botreso® (Phase III) and a two-year period for PCP (Phase II) – no drug-related serious adverse events were observed, indicating excellent safety and tolerability.

In contrast, current synthetic chemical drugs for BPH treatment are frequently accompanied by side effects such as orthostatic hypotension, erectile dysfunction, and decreased libido. Regulatory and research institutions have associated some synthetic alternatives with serious risks, prompting the US FDA to issue safety announcements regarding high-grade prostate cancer and depression in 2011, and to add suicidal ideation to adverse reaction lists in 2022, alongside independent research linking them to cardiac failure in 2021.

Addressing the Risk of High-Grade Prostate Cancer

Large-scale international clinical trials have shown that while some synthetic drugs for BPH treatment reduce overall prostate cancer incidence, they may paradoxically increase the proportion of high-grade prostate cancer (Gleason Score ≥ 7) when cancer does occur, raising significant clinical safety concerns.

The PCP Phase II trial was a rare large-scale, long-term study in Taiwan, conducted across 20 major hospitals. It involved 135 urologists (representing more than one-tenth of the profession in Taiwan) and 702 subjects over a two-year period. It represents one of the world's first clinical trials of a botanical new drug conducted in Taiwan specifically for prostate cancer prevention. Results indicated that PCP shows a trend in reducing both overall prostate cancer incidence and the risk of high-grade prostate cancer, effectively addressing medical community concerns regarding the risks of current therapies.

Comprehensive "Treatment + Prevention + Metabolic Management"

Based on clinical data from the clinical trials conducted by the Company, the Company believes that it is establishing a differentiated product positioning:

Improves Lower Urinary Tract Symptoms (LUTS): Effectively addresses symptoms associated with enlarged prostates.
Prostate Cancer Prevention: Demonstrates preventative clinical potential.
Metabolic and Cardiovascular Protection: Reduces triglycerides (P=0.05), significantly lowers total cholesterol and LDL (bad cholesterol) (P<0.05) , significantly increases HDL (good cholesterol) (P<0.05) , and maintains stable blood sugar.

 

This integrated approach provides benefits without negatively affecting blood pressure, liver function, or kidney function. The Company believes that such a comprehensive profile – combining treatment, prevention, and metabolic management – is highly uncommon among current prostate medications and holds strong appeal for men over the age of 40.

Technological Barriers and Competitive Advantages

Due to the inherent complexity and diversity of their compositions, quality control for botanical new drugs is significantly more challenging than for small-molecule chemical drugs. Jianyong Biotech believes it has successfully established a comprehensive technological platform that includes:

The purification and establishment of reference standards.
The development and validation of analytical methods.
The execution of validation analyses and verification processes.

 

The Company believes this integrated capability creates a high barrier to entry, rendering the products highly difficult to replicate. Furthermore, it effectively mitigates the risks associated with counterfeiting and generic drug competition, which ultimately helps to extend the period of market exclusivity.

Upgraded Market Positioning and Strategic Value

As a Botanical New Drug protected by global patents, Jyong Biotech believes its market strategies leverage several key advantages:

Pricing Power: The unique metabolic protection and safety profile allow for premium pricing over off-patent generics, making it attractive to out-of-pocket and high-end medical markets.
Licensing Potential: The combination of high tolerability, excellent safety (no severe adverse reactions), and multiple clinical benefits makes it an ideal target for international pharmaceutical partnerships.
Market Scalability: Extends the product scope from a treatment-oriented approach into the fields of preventative medicine and health management.

 

Globally, over 500 million men aged 50 and above seek treatment for Benign Prostatic Hyperplasia (BPH). The global BPH drug market, valued at $4.1 billion in 2020, is projected to reach $9.8 billion by 2026. While the current treatment market generates approximately $6.5 to $7 billion annually, this figure reflects price reductions due to patent expirations; if valued at on-patent pricing, this market potential exceeds $20 billion annually*.

"Due to their complex composition, botanical new drugs present significant quality control challenges compared to small-molecule chemical drugs," stated Fu-Feng Kuo, Chairwoman and CEO of Jyong Biotech. "We have established a robust technology platform encompassing the purification of standard references, the development and validation of analytical methods, and the execution of validation analysis. This high barrier to entry makes imitation difficult, mitigates generic competition, and helps extend the period of market exclusivity."

"Botreso® is the first orally administered botanical new drug developed in Taiwan to receive US FDA Phase III clinical trial (API-1) IND approval and complete four Phase III trials," Kuo said. "Holding multi-national invention patents across Asia, the Americas, and the EU, Jyong Biotech has signed letters of intent and investment plans with several international pharmaceutical companies. The company aims to continue expanding strategic, royalty-bearing partnerships to support its global market expansion."

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.