Minsheng Securities: Huge market potential for gout, domestic URAT1 inhibitors clinical trials accelerating.

Minsheng Securities released a research report stating that existing gout medications have side effects such as hypersensitivity reactions, cardiovascular risks, and liver and kidney toxicity. The demand for newer, more effective, and safer uric acid-lowering drugs is increasingly evident in the market. URAT1 targeted drugs are expected to rapidly release market space in the next few years, with domestic enterprises leading the way in research and development, demonstrating the potential for continued commercialization and internationalization. Key attention is recommended to enterprises in this field with excellent clinical data, leading clinical progress, and potential for international expansion, such as Jiangsu Hengrui Pharmaceuticals, ApicHope Pharmaceutical Group, CMS, Yifang Biology, Xinnuwei, Tonghua Dongbao Pharmaceutical, and SIMCERE PHARMA. The main points of Minsheng Securities are as follows: The number of gout and hyperuricemia patients is in the hundreds of millions, with current drug sales close to 1 billion yuan, but there are many side effects, indicating a significant unmet clinical need. The prevalence of gout is continuously increasing, with a clear trend towards younger age groups. The prevalence of hyperuricemia in Chinese adults is 14%, and the prevalence of gout is 0.86% to 2.20%. Preliminary estimates suggest that there are approximately 10.23 to 26.18 million gout patients and about 167 million hyperuricemia patients in China, making a large patient population. Current gout treatment mainly relies on older generation uric acid-lowering drugs such as allopurinol, febuxostat, and probenecid. The sales of such drugs have been increasing steadily from 2020 to 2024, with sales in sample hospitals in China approaching 1 billion yuan in 2024. However, existing drugs have side effects such as hypersensitivity reactions, cardiovascular risks, and liver and kidney toxicity, leading to a growing demand in the market for newer, more effective, and safer uric acid-lowering drugs. URAT1 competitive landscape is favorable: only Lesinurad has been approved globally, with excellent Phase III data. As a new generation of targeted uric acid excretion drugs, URAT1 inhibitors have clear mechanisms, outstanding efficacy, and good safety, with high clinical potential and becoming a focus of new drug development. Currently, Eisai's Lesinurad is the only globally approved new generation URAT1 inhibitor, with a Phase III sUA compliance rate of 74%, significantly better than febuxostat (38.1%). The main adverse events are controllable, making it the first approved new generation URAT1 inhibitor. Domestic URAT1 inhibitor clinical progress is accelerating, with leading core product development pace internationally. Currently, most of the global research on URAT1 drugs is still in the II/III phase, with a good competitive landscape. Chinese pharmaceutical companies are accelerating their innovative layout in the URAT1 target, with an overall research and development pace leading at the international level. Jiangsu Hengrui Pharmaceuticals' Ruzinurad (SHR4640) as the first domestically submitted innovative URAT1 drug application has shown a sUA compliance rate of 56.9% in Phase III clinical data and has demonstrated good acid-lowering efficacy and safety in combination with febuxostat treatment, with its application being accepted by the CDE in early 2025. ApicHope Pharmaceutical Group's AR882, CMS's ABP-671, Xinnuwei's XNW3009, SIMCERE PHARMA's epaminuradar, and 6 other domestic products have entered Phase III or II/III key stages, with AR882 having a compliance rate as high as 89%, leading in similar global products, showing solid therapeutic advantages and good tolerability. Domestic enterprises are gradually establishing a product lineup in this race, with comprehensive competitiveness in research and development capabilities, clinical data, and evaluation pace, poised to occupy a larger share in the global URAT1 innovative drug landscape. Risk warning: Product development safety and efficacy data may not meet expectations, product development progress may fall short of expectations, regulatory policy changes may pose risks, market competition may intensify risks, product capacity may fall short of expectations, generic drug risks, and centralized procurement risks.