Jyong Biotech Seeks Partners for Phase III BPH Drug Amid Complete Data Vacuum and Precedent Uncertainty

Jyong Biotech Reaffirms Global Licensing Focus for BPH Botanical Drug

Jyong Biotech Ltd. is reaffirming its strategic focus on global licensing partnerships to address the growing medical needs in the urology sector, particularly for Benign Prostatic Hyperplasia (BPH). The company, the first Taiwanese firm to advance an oral botanical new drug to U.S. FDA Phase III clinical trials, is actively engaging with international pharmaceutical companies. This strategy is driven by the increasing global BPH patient population, projected to reach 150-156 million by 2035, and a market size estimated to grow from $13 billion in 2025 to $22-22.6 billion by 2035. Jyong Biotech aims to provide safer, long-term treatment options for BPH, addressing the high discontinuation rates of existing therapies.

• Jyong Biotech is actively pursuing global licensing partnerships to expand its cooperation network and address unmet medical needs in urology, leveraging its differentiated botanical drug platform. This strategy builds on its recent participation at BIO 2026 and existing collaborations, aiming to introduce its innovative plant-derived therapeutics to the global market.
• The press release highlights the substantial and growing market for Benign Prostatic Hyperplasia (BPH) treatment. The global BPH patient population is projected to increase from 112.5 million in 2021 to 150-156 million by 2035, with the market size expected to grow from approximately $13 billion in 2025 to $22-22.6 billion by 2035, driven by global population aging.
• Jyong Biotech is developing Botreso® (API-1), an oral botanical new drug candidate, which has undergone four Phase III clinical trials in Taiwan and the US. This drug aims to overcome the severe side effects and high discontinuation rates (60-90%) associated with current BPH treatments like alpha-blockers and 5-alpha reductase inhibitors, offering a safer, long-term alternative.

Why Current BPH Treatments Fall Short for Patients

While the benign prostatic hyperplasia (BPH) treatment landscape offers a spectrum of options from pharmacotherapy to major surgery, significant challenges persist for both clinicians and patients. Current approaches often involve a trade-off between efficacy, safety, and durability, highlighting an ongoing need for more definitive and less burdensome solutions.

• Limited Efficacy and Tolerability of Medical Therapy: Pharmacological agents, including 5α-reductase inhibitors and alpha-blockers, provide only moderate symptom relief, with mean International Prostate Symptom Score (IPSS) improvements of 3-10 points. Their utility is constrained by adverse effects—such as finasteride-induced testicular apoptosis and other impacts on quality of life—which can limit long-term adherence and fail to halt disease progression in all patients.

• Morbidity of Gold-Standard Surgery: Transurethral resection of the prostate (TURP) remains the surgical reference standard for efficacy, providing superior and more durable symptom relief than other modalities. However, this effectiveness comes with notable morbidity, including risks of retrograde ejaculation, erectile dysfunction, and incontinence, making it a less attractive option for patients prioritizing the preservation of sexual and urinary function.

• Durability and Data Gaps in Minimally Invasive Techniques: Newer minimally invasive surgical techniques (MISTs) like prostatic urethral lift and water vapor therapy offer a superior safety profile with significantly lower rates of sexual dysfunction. This advantage is counterbalanced by a higher need for surgical retreatment (up to 21% for some procedures) compared to TURP and a lack of long-term, prospective clinical trial data to fully appraise their long-term efficacy and cost-efficiency.

• Failure to Address Underlying Pathophysiology: Current treatments primarily manage symptoms without addressing the fundamental cellular mechanisms driving the disease. The clonal proliferation of prostate stem cells is considered a key reason for prostate regrowth following therapy, leading to treatment failure and the eventual need for additional interventions.

• Unpredictable Disease Progression: The natural course of BPH is characterized by a waxing and waning of lower urinary tract symptoms. This makes it difficult for clinicians to predict an individual patient's likelihood of progressing to future complications, such as acute urinary retention, which complicates decisions around the optimal timing and selection of interventions.

Positioning Botreso Against Current BPH Standard of Care

Recent studies offer direct comparisons between established standard-of-care treatments for benign prostatic hyperplasia (BPH) and emerging investigational therapies. While pharmacotherapy and traditional surgery remain foundational, minimally invasive surgical therapies (MISTs) and other novel approaches are being evaluated for their relative efficacy, safety, and patient-reported outcomes. The data highlight a shifting landscape where newer modalities demonstrate competitive, and in some cases superior, results against current standards.