随着生活水平的提高，痛风的发病率越来越高，且呈现年轻化的趋势。 2024年，国内的高尿酸血症患者约2.21亿人，痛风患者约2530万人，相当于每100个人中，就有1-2个人患痛风。 近期，有一家专注于痛风领域的创新药公司冲击港股IPO。 格隆汇获悉，杭州新元素药业股份有限公司（简称：新元素药业）递表港交所，以18A章规则寻求港股上市，由中信 证券担任保荐人。 目前，痛风领域存在未满足的需求，不过，新元素药业也面临恒瑞医药、康缘药业、通化东宝、丽珠医药等老牌企业 的竞争。 丽珠集团、红杉参投，最新估值约30亿元 新元素药业成立于2012年，由史东方博士创立，2025年5月改制为股份公司，总部位于浙江省杭州市钱塘区。 截至2025年9月9日，史博士直接拥有公司已发行股本总额约30.3%的权益。 自成立以来，新元素药业已获五轮股权融资，合计约10.78亿元，主要机构投资者包括凯泰资本、丽珠集团 （000513）、新动力、和达基金、红杉中国、高特佳、达晨资本、倚锋创投等。 其中，凯泰资本从A轮开始参与，连续5轮押注。 在2025年8月的增资中，新元素药业的投后估值约30.52亿元。 | | A輪融資 | A+輸融資 ...

Core Insights - The increasing prevalence of gout and hyperuricemia in China presents a significant market opportunity for innovative treatments, with approximately 221 million hyperuricemia patients and 25.3 million gout patients projected for 2024 [2][13]. - New Element Pharmaceuticals, a company focused on gout treatment, is seeking to go public in Hong Kong, facing competition from established firms like Hengrui Medicine and Kanyuan Pharmaceutical [3][16]. Company Overview - New Element Pharmaceuticals was founded in 2012 and has undergone five rounds of financing, raising approximately 1.078 billion RMB, with a current valuation of about 3 billion RMB [4][6]. - The company is led by Dr. Shi Dongfang, who has extensive experience in drug development and holds a significant stake in the company [8][4]. Product Pipeline - The company is developing two clinical-stage products, ABP-671 and ABP-745, targeting gout and hyperuricemia, along with several preclinical candidates [16][26]. - ABP-671 is a URAT1 inhibitor currently in phase 2b/3 clinical trials in the US and China, showing promise as a first-line treatment for gout [18][20]. Financial Performance - New Element Pharmaceuticals has reported significant losses over the past two and a half years, totaling 696 million RMB, with no products approved for commercial sale yet [29][31]. - The company's R&D expenses have been substantial, accounting for over 90% of total operating expenses, indicating a strong focus on developing its drug pipeline [32][33]. Market Landscape - The global market for hyperuricemia and gout treatments is estimated at approximately 3.2 billion USD, with a growing need for safer and more effective therapies [12][20]. - The competitive landscape includes multiple established pharmaceutical companies and over 100 generic drugs approved for treating hyperuricemia and gout, highlighting the challenges New Element Pharmaceuticals faces [20][22][23].

Core Insights - Gout is a significant health issue in China, with over 30% of the world's gout patients residing in the country, projected to reach nearly 18 million by 2025 [1] Group 1: Gout Prevalence and Treatment - China accounts for 17.4% of the global population but has over 30% of the world's gout patients, indicating a high prevalence of the disease [1] - The prevalence of hyperuricemia among Chinese adults reached 14% according to 2018-2019 data, with some progressing to gout [1] Group 2: Treatment Approaches - Gout treatment is divided into acute phase relief and chronic uric acid lowering therapy, with first-line medications including colchicine and NSAIDs for acute treatment [2] - Common medications for uric acid lowering include xanthine oxidase inhibitors (allopurinol, febuxostat), uricosuric agents (benzbromarone, probenecid), and uricase agents (pegloticase, rasburicase) [2] Group 3: Research and Development in Uric Acid Lowering - Research on uric acid lowering treatments is focused on URAT1 inhibitors, with drugs like Molnupiravir showing promising efficacy and safety, potentially becoming first-line treatments [3] - The competition in the URAT1 inhibitor space remains intense, with several candidates still awaiting further clinical efficacy data [3] Group 4: Acute Phase Relief Innovations - Research for acute phase relief is centered on IL-1β inhibitors, with the approval of Vusirikumab, the first IL-1β inhibitor in China, which significantly reduces the risk of recurrence by over 90% [4] - Vusirikumab's pain relief efficacy is comparable to that of combination betamethasone, marking a significant advancement in gout treatment [4]

Summary of the Conference Call for Yipinhong Company Overview - Yipinhong focuses on pediatric and chronic disease medications, with a strong emphasis on research and development. The company has over 20 years of experience in the pharmaceutical industry, showcasing robust capabilities in production, research, and sales channels [5][20]. Key Product: AR882 - AR882 is a novel gout treatment drug that demonstrates exceptional safety and efficacy, particularly in dissolving gout stones, positioning it as a potential best-in-class medication [2][6]. - The drug is currently undergoing global multi-center clinical trials, with interim data from overseas Phase III trials expected by the end of September 2023 [2][19]. - AR882 shows a significant uric acid reduction rate of 53%, outperforming allopurinol (35%) and febuxostat (30%) [2][15]. - Imaging data indicates that AR882 effectively dissolves both large and small gout stones [2][15]. - In a high-dose group presented at the European Rheumatology Annual Meeting, AR882 rapidly reduced blood uric acid levels to 4 mg/dL and maintained low levels over a year and a half, achieving a target rate of nearly 80% for levels below 6 mg/dL and 50% for levels below 4 mg/dL [16][17]. Market Potential - There are approximately 200 million patients with hyperuricemia in China, with about 20 million suffering from gout. Traditional uric acid-lowering medications have limitations, creating a significant market opportunity for AR882 [2][7][8]. - The global market for gout medications is projected to grow, with a notable increase in demand for new, effective treatments due to the limitations of existing therapies [13]. Clinical Trial Progress - The enrollment for the overseas Phase III trial is nearing completion, while the domestic Phase III trial aims to enroll over 600 patients, with more than 300 already enrolled [3][4][19]. - The company has a strong pipeline, with expectations to complete global Phase III trials by mid-2026 [4][19]. Safety Profile - AR882 has shown good safety in long-term treatment, with no liver or kidney toxicity events reported during a year and a half of observation. Most adverse reactions were mild to moderate [18][19]. Financial and Strategic Outlook - Yipinhong has launched a new equity incentive plan with performance targets, including a net profit growth rate of no less than 32%, reflecting strong confidence in future growth [3][4][21]. - The company is also exploring AI healthcare and molecular glue technologies, which are expected to contribute to future growth [20]. Conclusion - Yipinhong's AR882 is positioned to fill a significant gap in the gout treatment market, with promising clinical data and a strong development pipeline. The company's strategic initiatives and market potential suggest a positive outlook for future growth and profitability [2][19].

Core Insights - The upcoming EULAR conference in Barcelona will showcase innovative research on the gout drug AR882 by Yipinhong, attracting over 130 countries' experts in rheumatology [1] - AR882 is a next-generation URAT1 inhibitor that promotes uric acid excretion and avoids renal toxicity, with a once-daily dosing regimen [1][2] - The drug has received Fast Track Designation from the FDA for gout stone research, potentially filling a gap in oral medications for gout stone treatment [1] Group 1 - AR882 is currently in global Phase III clinical trials, with over a thousand participants enrolled [2] - The drug demonstrates three breakthrough therapeutic effects: precise uric acid control, dissolution of gout stones, and safety without renal toxicity [2] - Clinical data shows that AR882 can significantly reduce uric acid crystal volume and achieve complete dissolution of at least one target gout stone [2][3] Group 2 - In an 18-month treatment period, AR882 showed good tolerability with no clinically significant adverse events or laboratory abnormalities [2] - Patients treated with AR882 maintained serum uric acid levels at clinically meaningful levels of less than 4 mg/dL [3] - The high response rate for complete dissolution of gout stones and rapid reduction in uric acid crystal volume indicates a significant improvement in patients' quality of life [2]

Investment Rating - The report maintains a positive investment outlook on URAT1 inhibitors, suggesting that they are expected to rapidly capture market opportunities in the coming years, particularly for domestic companies with strong clinical data and internationalization potential [4][6]. Core Insights - The gout and hyperuricemia patient population is substantial, with estimates of approximately 10.23 to 26.18 million gout patients and around 167 million hyperuricemia patients in China, indicating a significant unmet clinical need due to the side effects of existing medications [1][12][25]. - The global market for URAT1 inhibitors is competitive, with only one drug, Lesinurad, approved so far, which has shown superior efficacy in clinical trials compared to existing treatments [2][28]. - Domestic companies are advancing rapidly in the development of URAT1 inhibitors, with several products in late-stage clinical trials demonstrating promising efficacy and safety profiles [3][32]. Summary by Sections 1. Gout/Hyperuricemia and URAT1 Target Overview - The prevalence of gout and hyperuricemia is increasing, with a notable trend towards younger patients, and the current treatment options have significant side effects, highlighting a large unmet clinical demand [1][24][25]. - Existing medications for gout, such as allopurinol and febuxostat, have seen sales growth, but their side effects create a demand for safer and more effective alternatives [1][17][24]. 2. Domestic URAT1 Inhibitors Flourishing - URAT1 inhibitors work by inhibiting uric acid reabsorption, promoting uric acid excretion, and thus lowering serum uric acid levels [26]. - The first approved URAT1 inhibitor, Lesinurad, has shown a 74% success rate in clinical trials, significantly outperforming existing treatments [2][35]. - Several domestic companies, including HengRui Medicine and Yipinhong, are leading in the development of URAT1 inhibitors, with multiple candidates showing high efficacy rates in clinical trials [3][32][40]. 3. Investment Recommendations - The report recommends focusing on companies with strong clinical data and progress in the URAT1 inhibitor space, such as HengRui Medicine, Yipinhong, and Kangzhe Pharmaceutical, which are well-positioned for commercialization and international expansion [4][5].

Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The company is expected to see significant growth in its innovative segment, particularly with the upcoming realization of a major product for gout treatment [5][6] - The projected net profit for the company from 2025 to 2027 is estimated to be 200 million, 270 million, and 330 million RMB respectively, with year-on-year growth rates of 136.2%, 37.2%, and 22.4% [6] Financial Performance Summary - The company reported a revenue of 1.45 billion RMB in 2024, a decrease of 42.07% year-on-year, and a net loss of 540 million RMB, a decline of 392.52% year-on-year [8] - For Q1 2025, the revenue was 377 million RMB, down 39.48% year-on-year, with a net profit of 57 million RMB, a decrease of 43.70% year-on-year [8] - The company has a total market capitalization of approximately 17.7 billion RMB and a circulating market capitalization of about 16.36 billion RMB [3] Business Segments - In 2024, the children's medicine segment generated revenue of 936 million RMB, while the chronic disease medicine segment brought in 370 million RMB [8] - The company has 26 registered children's medicine products covering over 70% of childhood diseases [8] Research and Development - The company is advancing its AR882 product, which has shown promising results in reducing uric acid levels and dissolving gout stones, indicating a potential competitive edge in the market [8] - The company has received several new product registrations in the chronic disease segment, enhancing its product portfolio [8] Financial Projections - The projected revenue for 2025 is 1.82 billion RMB, with a year-on-year growth rate of 25.31% [9] - The estimated net profit for 2025 is 195 million RMB, with a significant recovery from the previous year's loss [9]

从研发进展来看，长春高新的伏欣奇拜单抗已取得重要突破。目前，注射用伏欣奇拜单抗(粉剂)用于急 性痛风性关节炎的上市申请已于2024年4月获受理；同时，该药物针对全身型幼年特发性关节炎的适应 症已进入Ⅲ期临床试验阶段，针对结缔组织病相关间质性肺病的适应症也正处于Ⅱ期临床试验阶段。此 外，伏欣奇拜单抗注射液(水剂)用于急性痛风性关节炎的上市申请在2025年1月也已获受理。 长春高新（000661）(000661.SZ)子公司金赛药业相关市场部负责人此前接受媒体采访时指出，目前国 内痛风急性期治疗主要使用抗炎药(秋水仙碱、NSAIDs、糖皮质激素)和降尿酸药(别嘌醇、非布司他)。 前者易致胃肠道反应及肝肾损伤，后者虽能降尿酸但存在过敏、致死性皮炎等超敏反应综合征风险。值 得注意的是，FDA已明确要求，非布司他的药品说明书需增加黑框警告，提示其可能增加患者的死亡风 险。此外，除了上述药物，目前已上市的痛风石溶解药物普瑞凯希(Pegloticase)因价格昂贵和安全性问 题在国内也未普及。 针对这一临床需求，长春高新自主研发了一款抗白介素1β(IL-1β)单抗——伏欣奇拜单抗(曾用名金纳单 抗)，该药物属于治疗用生物制 ...

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [6]. Core Viewpoints - The company's main business is expected to stabilize and recover, with significant potential for the gout drug AR882, which is currently leading in global development and may become a market leader due to its clinical efficacy [4][8]. - The company has faced performance pressures since 2022 due to industry procurement disruptions and changes in the market environment, but these impacts are expected to diminish, leading to a recovery in its core business [8][10]. - The global gout market remains largely untapped, with a significant patient base and existing treatment gaps, indicating a promising market potential for AR882 [39][40]. Summary by Sections 1. Core Business Recovery and Innovation - The company focuses on pediatric and chronic disease sectors, demonstrating stable long-term operations [13]. - Short-term operations have been affected by external factors, but the introduction of stock incentives is expected to bolster confidence in the core business [21][26]. - Continuous increases in R&D investment are aimed at bringing the innovative gout drug AR882 to market [34][38]. 2. Gout Market Potential - There is a large patient base for gout, with clinical treatment gaps that innovative drugs can address [39]. - The existing treatments for gout have notable clinical deficiencies, creating opportunities for new entrants like AR882 [40][41]. - The company’s U.S. subsidiary, Arthrosi, has a strong management team with extensive experience in gout drug development, enhancing the prospects for AR882 [56][60]. 3. Financial Forecast and Valuation - The company is projected to have a net profit of -561 million RMB in 2024, followed by recoveries to 199 million RMB in 2025 and 261 million RMB in 2026 [5][6]. - The estimated price-to-earnings ratios for 2025 and 2026 are 80 and 61, respectively, based on the expected net profits [6].