Business UpdateMay 29, 2026, 08:02 AM
Jyong Biotech Details Botreso® FDA Strategy; Targets 2029-2030 NDA
AI Summary
Jyong Biotech Ltd. outlined its strategic vision, focusing on its lead botanical asset, Botreso®, for benign prostatic hyperplasia (BPH). CEO Fu-Feng Kuo detailed the significant market opportunity with 12.2 million BPH patients in the US, noting issues with existing synthetic therapies. The company is fortifying its New Drug Application (NDA) for Botreso® with extensive data, including two pivotal studies. Jyong Biotech aims for a combined NDA submission in 2029-2030, pending a US pharmacokinetic study and a Phase III trial. The company also highlighted its Prostate Cancer Prevention (PCP) asset, which completed Phase II trials, and is seeking co-development partners.
Key Highlights
- Jyong Biotech's lead botanical asset, Botreso®, targets benign prostatic hyperplasia (BPH).
- The US market for BPH has approximately 12.2 million patients.
- 35% of BPH patients are in "watchful waiting"; 9.1% discontinue treatment due to side effects.
- Botreso®'s NDA case is based on API-1, supported by two pivotal and two one-year open-label extension studies.
- Required studies for FDA include a US pharmacokinetic study and a Phase III trial utilizing API-2.
- Company targets a combined NDA submission for Botreso® in the 2029-2030 timeframe.
- Prostate Cancer Prevention (PCP) asset completed Phase II trial in Taiwan.
- Jyong Biotech is engaged in discussions with major pharmaceutical companies for PCP co-development.
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