Epaminurad

- Confirms superiority over ‘Febuxostat 40mg’ with excellent serum uric acid-lowering effect - Secures favorable safety pro target product approval in South Korea in 2027 SEOUL, South Korea--(BUSINESS WIRE)-- #Biotechnology -- JW Pharmaceutical (KRX:001060) announced that the multinational Phase 3 clinical trial of its gout treatment candidate ‘Epaminurad (code name URC102)’ demonstrated excellent serum uric acid-lowering effects and statistical superiority for its main development dose of 6mg compared to the existing treatment. Epaminurad is an oral uricosuric agent with a mechanism that selectively inhibits the human uric acid transporter-1 (hURAT1) to suppress the reabsorption of uric acid in the kidneys and promote its excretion. It is a new drug candidate currently under development for patients with hyperuricemia and gout who have abnormally high levels of serum uric acid. This Phase 3 clinical trial was conducted on 612 gout patients across 52 centers in five Asian countries, including South Korea, Taiwan, Thailand, Malaysia, and Singapore. It was designed as a multicenter, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of Epaminurad (6mg, 9mg) in comparison to Febuxostat, an existing uric acid production inhibitor. The analysis of the primary efficacy endpoint—the proportion of patients achieving a serum uric acid (sUA) concentration of less than 6 mg/dL in the last three measurements of the main study period—showed that the Epaminurad 6mg group recorded 50.0% (76/152 patients), demonstrating a higher treatment response rate than the control group, Febuxostat 40mg (38.3%, 59/154 patients). The response rate difference between the two groups was 12.0%p (95% confidence interval 1.26~22.6), satisfying non-inferiority criteria and proving statistical superiority. An excellent pro also confirmed in the safety evaluation. There was no significant difference in the incidence of Treatment-Emergent Adverse Events (TEAEs) between the Epaminurad and Febuxostat groups during the treatment period. The incidence rates of Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs), and Adverse Events of Special Interest (AESIs) also showed similar levels. No drug-related deaths were reported during the clinical trial period. The high-dose 9mg group did not meet the statistical non-inferiority criteria for the primary efficacy endpoint compared to Febuxostat 80mg. However, the proportion of patients achieving a serum uric acid (sUA) concentration of less than 6 mg/dL in the last three measurements of the main study period was 59.6% (87/146 patients) in the Epaminurad 9mg group and 63.3% (95/150 patients) in the Febuxostat 80mg group, with a response rate difference of approximately 4%p between the two groups. Based on the overall clinical data and subgroup analysis results for the high dose, JW Pharmaceutical plans to further review the efficacy pro specific patient populations and explore approval strategies for the high dose. Based on these clinical results, JW Pharmaceutical plans to proceed with a New Drug Application (NDA) aiming for regulatory approval in South Korea in 2027. Epaminurad was selected as a pilot project for the South Korean Ministry of Food and Drug Safety (MFDS)'s ‘New Drug Approval and Evaluation Innovation Plan,’ and completed two ‘Pre-NDA meetings’ last July. In addition, the company plans to pursue out-licensing opportunities for global market entry continuously. Eun-Kyung Hahm, CEO of JW Pharmaceutical, stated, “There is a substantial unmet need for new treatment options due to the increase in gout patients and safety concerns regarding existing treatments.” She added, “As we have proven superior efficacy and a favorable safety pro to Febuxostat 40mg, the most prescribed in the South Korean gout treatment market, we will concentrate our capabilities on preparing the product approval process without a hitch so that Epaminurad can establish itself as a Best-in-Class drug.” According to a pharmaceutical market research firm UBIST, the South Korean gout treatment market is estimated at approximately 41.1 billion KRW as of 2025. Febuxostat products lead the market with roughly 34.7 billion KRW (84.4%), with Febuxostat 40mg accounting for over 63% of the entire market, with prescription sales of about 26 billion KRW. A global market research firm Grand View Research expects the global gout treatment market to grow from approximately USD 2.8 billion in 2024 to USD 4.1 billion in 2030. (USD 1 = KRW 1,411) About JW Pharmaceutical Founded in 1945, JW Pharmaceutical Corporation has been a leader in Korea’s therapeutic pharmaceutical market, guided by its founding principles of respect for life and a spirit of challenge. With a robust portfolio of original medicines, JW Pharmaceutical has focused on innovative drug discovery and development since establishing its Central Research Institute in 1983 and the C&C Research Laboratories in 1992. Through advanced research technologies, including its AI-based drug discovery and development platform, JWave, the company has built a strong pipeline in oncology, immunology, and regenerative medicine. JW Pharmaceutical also actively pursues diverse research initiatives aligned with global trends through open innovation. JW Pharmaceutical Corporation is listed on the Korea Exchange under the ticker “001060.” Contacts JW Pharmaceutical Jung-jae Yoo Head of PR, Corporate Communications jw_pr@jw-group.co.kr