Jyong Biotech Ltd.

Jyong Biotech Ltd. is a science-driven biotechnology company based in Taiwan that develops and commercializes innovative, differentiated new drugs derived from plants. The company primarily focuses on treating urinary system diseases, targeting markets in the U.S., the EU, and Asia. Since its inception in 2002, Jyong Biotech has established integrated capabilities covering all key aspects of drug development, including early-stage discovery, clinical trials, regulatory affairs, manufacturing, and commercialization. The company leverages its research and development capabilities and proprietary platform to develop a series of botanical drug candidates. Its primary botanical drug candidate is Botreso, alongside another clinical-stage botanical drug candidate and other preclinical-stage botanical drug candidates. Jyong Biotech resubmitted a new drug application (NDA) for Botreso with the U.S. FDA on December 17, 2021, using Active Pharmaceutical Ingredient (API)-1. The company voluntarily withdrew this NDA on November 30, 2022, to gather more information about API-2 for the U.S. FDA's review. This withdrawal also aimed to address ongoing questions regarding the demonstrated difference between Botreso and placebo for the primary efficacy endpoint in a clinical study for Botreso, and other U.S. FDA questions related to the drug substance and product, validation of methods, manufacturing, clinical and nonclinical testing, data, and statistical analyses. In a June 26, 2023 response to a meeting request regarding refiling the NDA for Botreso using API-2, the U.S. FDA stated that the provided information on API-2 was not yet sufficient to demonstrate comparability with API-1, as only preliminary comparative drug substance and drug product specifications were provided. The FDA also noted the statistically significant difference between Botreso and placebo in the primary efficacy endpoint in Study MCS-2-US-a, one of the company's Phase III pivotal studies.