Jyong Biotech CEO targets 2029-2030 FDA NDA filing for Botreso, PharmaBoardroom interview says
PUBT · 05/29 12:05
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- Jyong Biotech CEO Fu-Feng Kuo outlined an FDA plan for Botreso, its lead botanical drug candidate for benign prostatic hyperplasia.
- Targeted combined NDA submission in 2029-2030, contingent on a US pharmacokinetic comparability study for API-1 versus API-2.
- Planned Phase III trial using API-2 to support supply-chain requirements for FDA review.
- Two pivotal studies, two one-year open-label extensions in the US and Taiwan cited as showing no emergent safety signals.
- US commercialization prioritized first, positioning FDA approval as a gateway for Brazil, Israel, and broader Asia.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Jyong Biotech Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605290800PRIMZONEFULLFEED9728771) on May 29, 2026, and is solely responsible for the information contained therein.
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