Tai-Chung Announces Positive Interim Analysis Results from Phase III Clinical Trial of U101 for Recurrent UTI Prevention

1. Date of financial and business information release: July 23, 115 2. Location of release: Taiwan Stock Exchange 3. Publicly disclosed financial and business-related information: Interim analysis of the Phase III human clinical trial of U101 4. Content of the press release:

Tai-Chung Biotech Co., Ltd. (hereinafter referred to as "Tai-Chung", stock code: 4169) today announced significant progress in the interim analysis (Interim Analysis) of its Phase III human clinical trial in Taiwan for U101, a novel therapeutic drug developed for the prevention of recurrent urinary tract infections (rUTI). Following a rigorous review by the External Independent Data Monitoring Committee (IDMC), the overall safety profile of the trial was confirmed to be satisfactory, and the committee recommended that the trial "continue as originally planned." The company will continue to fully advance the trial to achieve its enrollment target of 348 participants.

The overall duration of the Phase III clinical trial for U101 in Taiwan is 48 weeks, divided into two main stages: the "Main Study" and the "Open-Label Extension period (OLE)." The Main Study lasts 24 weeks and employs a randomized, double-blind, placebo-controlled design. Participants who meet the criteria during the subsequent OLE phase may continue receiving U101 treatment for an additional 24 weeks to further evaluate long-term efficacy and safety. According to the trial protocol, the interim analysis is triggered when 60% (i.e., 208 participants) have completed 24 weeks of treatment or when at least one urinary tract infection episode has occurred. Based on the interim analysis plan, the IDMC will make recommendations based on safety and efficacy data, including: (1) recommending trial termination due to safety concerns; (2) recommending termination if further enrollment is unlikely to achieve statistical significance for the primary efficacy endpoint; or (3) recommending early termination of enrollment if pre-specified stringent statistical criteria for efficacy have already been met. If none of these conditions are met, the recommendation is to continue the trial as planned.

Following completion of the interim analysis, the IDMC recommended that the Phase III clinical trial of U101 continue enrollment and execution as originally planned, indicating that no safety or other major issues requiring trial suspension or design modification have been identified at this stage, supporting the continued progression of the trial toward final analysis. 5. Other disclosures: None