Duyuru • Jul 02
Jyong Biotech Showcases Botanical Drug Portfolio At BIO 2026 International Convention Jyong Biotech Ltd. participated in the BIO International Convention (BIO 2026), held in San Diego, California, from June 22 to June 25, 2026. Jyong Biotech once again exhibited at the Taiwan Pavilion. The Company conducted in-depth discussions with global pharmaceutical companies, investment institutions, and industry partners and had the opportunity to present the Company and its assets to them. During the convention, Jyong Biotech presented its botanical new drug candidate, Botreso (API-1), to international pharmaceutical companies as the Company continues advancing global licensing discussions. Targeting benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), the Company has conducted four Phase III clinical trials for Botreso across the United States and Taiwan. The Company believes the drug candidate offers a potentially attractive solution for long-term treatment needs, backed by its proven safety, tolerability, and clinical profile. Driven by an aging global population and rising obesity rates, the BPH and LUTS market continues to expand, with the number of BPH patients projected to grow by 35% to 40% between 2021 and 2035 according to the Global Burden of Disease (GBD 2021) study and BMC Urology. Jyong Biotech is accelerating its New Drug Application (NDA) preparations and global licensing plans. Supported by initial licensing agreement and active discussions with several pharmaceutical partners, the Company aims to expedite commercialization in key markets—including the US, Europe, and Asia—through regional licensing and strategic alliances. As of the date of this press release, Botreso and PCP remain investigational new drug candidates and have not been approved for commercial use in any jurisdiction. Jyong Biotech will comply with applicable regulatory disclosure obligations and provide timely, accurate, and complete updates on material developments. Duyuru • Mar 28
Jyong Biotech Ltd Updates the Potential Clinical Benefits and Advantages of Its Plant-Derived Innovative Drug MCS-2 Jyong Biotech Ltd. provided an update on the plant-derived innovative drug MCS-2 of its multiple competitive advantages and its potential clinical benefits in the treatment of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS). Developed in Taiwan, MCS-2 is the world’s only oral botanical new drug to have completed a global Phase III clinical trial for benign prostatic hyperplasia (BPH). Jyong Biotech has conducted four Phase III clinical trials (API-1) in the U.S. and Taiwan, including two pivotal trials (one in the U.S. and one in Taiwan) and two open-label extension studies (one in the U.S. and one in Taiwan), and completion of the Phase III clinical trial report was achieved in 2017. In the U.S., trials were conducted across 27 centers in 19 states, involving over 200 urologists. In Taiwan, trials took place in 12 major hospitals, including multiple medical centers, with participation from more than 70 urologists (over one-tenth of all urologists in Taiwan). Jyong Biotech strictly adheres to FDA guidelines and standards throughout its drug development process. MCS-2 (API-1) has completed Phase I through Phase III clinical validation, along with more than ten international toxicology studies. Across all four Phase III trials in Taiwan and the U.S., the drug demonstrated excellent safety, with no serious adverse events, supporting its suitability for long-term use. The company believes that its core technology significantly enhances bioavailability and enables the development of multiple formulations and indications, including oral formulations, injectable forms, and bladder instillation therapies. These innovations are protected by patents across the Americas, Asia, Europe, and other regions, forming a global portfolio that effectively overcomes existing patent barriers established by major pharmaceutical companies. BPH/LUTS is a common age-related condition affecting hundreds of millions of men worldwide. Current treatments for BPH/LUTS are associated with side effects and drug resistance, impacting patient compliance and satisfaction. There is therefore an urgent unmet need for a safe, long-term therapeutic solution. MCS-2 is being developed to address this gap, offering clear competitive advantages. As of present day, MCS-2 remains an investigational new drug candidate and has not been approved for commercial use in any jurisdiction. Jyong Biotech will comply with applicable regulatory disclosure obligations and provide timely, accurate, and complete updates on material developments. Duyuru • Feb 12
Jyong Biotech Ltd. Reports Transformative Period of Clinical Validation and Commercialization Efforts: Phase II Data Jyong Biotech Ltd. issued a strategic corporate update. This review encapsulates a pivotal period characterized by the successful completion of the Phase II clinical trial for its lead candidate, MCS-8, and the concurrent attempt of its commercial footprint in key Asian markets. The Company believes the convergence of positive oncological endpoints with unexpected metabolic benefits potentially de-risks its pipeline and positions Jyong Biotech at the forefront of preventative medicine. The Company recently achieved an important milestone with the completion of its Phase II randomized, placebo-controlled trial for MCS-8, which enrolled over 700 high-risk subjects across 20 medical centers in Taiwan. As previously disclosed, the study's primary efficacy analysis yielded a statistically significant 27.3% reduction in the overall incidence of prostate cancer in the MCS-8 arm compared to placebo. The data also demonstrated a 17.1% reduction in high-grade prostate cancer. This finding is clinically profound, as high-grade malignancies represent the primary driver of prostate cancer mortality, and historical chemoprevention agents have often struggled to demonstrate safety or efficacy in this specific sub-population. Further pathological stratification revealed a 35.2% reduction in the percentage of positive biopsy cores and a 24.4% reduction in the cancer-positive area within those cores. These metrics suggest that MCS-8 exerts a tangible biological effect on tumor burden and disease progression, potentially offering a superior alternative to the current standard of "active surveillance," which carries the psychological burden of anxiety for patients waiting for disease progression. Furthermore, non-binding strategic alliances in Korea and Vietnam demonstrate commitment to ensuring these innovative therapies reach patients efficiently. The company are moving forward with a clear vision to redefine the standard of care in preventative neurology. As of present day, MCS-2 and MCS-8 remain investigational new drug candidates and have not been approved for commercial use in any jurisdiction. Jyong Biotech will comply with applicable regulatory disclosure obligations and provide timely, accurate, and complete updates on material developments. Duyuru • Feb 07
Jyong Biotech Ltd. Announces Chief Financial Officer Changes, Effective February 6, 2026 Jyong Biotech Ltd. announced that Wei (Vivi) Zhang has been appointed as the Company's Chief Financial Officer, effective February 6, 2026, replacing Alfred Ying. Ms. Wei (Vivi) Zhang is an experienced finance executive with extensive leadership experience in initial public offerings, funds raising and public companies. Most recently, Ms. Wei served as a consultant for a private company in its initial public offering process. Before that, from 2019 to January 2024, she served as Chief Financial Officer and director at Global Mofy AI Limited (f/k/a Global Mofy Metaverse Limited) (listed on Nasdaq since October 2023: GMM). Ms. Zhang received a bachelor's degree in accounting from the University of South Australia and an MBA degree from the University of Oxford. Duyuru • Jan 30
Jyong Biotech Subsidiary Announces Phase Ii Clinical Data on Cholesterol and Ldh Indicators for Mcs-8 (Pcp) Indicating Potential in Prostate Cancer Prevention and Metabolic Value Jyong Biotech Ltd. announced updated statistical analyses for key blood biochemical markers from its Phase II clinical trial of MCS-8 (PCP) conducted in Taiwan. The results underscore MCS-8's previously indicated multifaceted clinical and commercial potential beyond its clinical evidence in prostate cancer prevention, showing its potential in helping alleviate high-grade malignancy risk. The data reveals significant new value in metabolic indicators, specifically cholesterol and lactate dehydrogenase (LDH). Building on this momentum, the Company is evaluating the feasibility of expanding MCS-8's indications to include lipid management, atherosclerosis, and cardiovascular diseases--a strategic move aimed at extending the product's lifecycle and significantly capturing a broader market share. The Phase II clinical trial demonstrated that after two years of treatment, subjects receiving MCS-8 showed improved lipid control compared with baseline, including: A statistically significant reduction in total cholesterol levels (P = 0.036); A statistically significant increase in serum lactate dehydrogenase (LDH) levels observed in the placebo group (P = 0.024), while no such increase was observed in the MCS-8 group. LDH is an enzyme widely present in organs and tissues throughout the body, and elevated serum LDH levels are commonly associated with cellular damage or cell death. The absence of LDH elevation in the MCS-8 Group suggests that MCS-8 may not be causing damage or death to the cell. As previously disclosed, the primary efficacy endpoint of the Phase II study showed that, compared with placebo, the MCS-8 group demonstrated a 27.3% reduction in overall prostate cancer incidence. Further pathological analyses demonstrated favorable trends, including a 35.2% reduction in the percentage of positive centers involved at diagnosis and a 24.4% reduction in the percentage of cancer-positive area involved in positive centers, compared with placebo, suggesting improved control of disease progression. Safety data from the previously disclosed analyses showed that long-term administration of MCS-8 for two years did not increase the rate of adverse events. No serious adverse events related to MCS-8 were observed, and no negative effects were identified on liver function, kidney function, or blood pressure. Company believes that the favorable tolerability profile supports the potential suitability of MCS-8 for long-term preventive use. MCS-8 is developed using Jyong Biotech's core patented pharmaceutical composition technology, which Company believes significantly enhances bioavailability and improves physiological efficacy, offering substantial potential for the development of multiple dosage forms and indications.Related research findings have been published in the international journal Nanotechnology and included by Global Medical Discovery institutions in Canada. MCS-8 remains an investigational new drug candidate and has not been approved for commercial use in any jurisdiction. 
