Jyong Biotech is a Taiwan-based, clinical-stage biotechnology company that develops plant-derived drug candidates for urological conditions. The company primarily focuses on treating benign prostatic hyperplasia (BPH) and preventing prostate cancer using botanical ingredients derived from tomato plants. Its lead product candidate, Botreso, is a softgel capsule intended to treat BPH symptoms by providing a better tolerability profile than synthetic chemical treatments. A second candidate, PCP, utilizes the same active ingredients to target prostate cancer prevention. Jyong also has an injectable candidate for interstitial cystitis in preclinical development. The company currently has no commercialized products and generates no revenue. Its business model relies on securing regulatory approvals to sell products through an internal sales force in Taiwan and through licensing and distribution partnerships in international markets, including the U.S., EU, and Asia. A critical component of Jyong's current strategy involves demonstrating to the FDA that its new active pharmaceutical ingredient source is comparable to its original source, which is no longer available. This regulatory acceptance is a prerequisite for advancing clinical trials and resubmitting its New Drug Application for Botreso.