中经记者苏浩卢志坤北京报道 2018年11月，海创药业自主研发的高尿酸血症和痛风1类新药HP501缓释片获得国家药监局颁发的《临 床试验通知书》。公司满怀希望地宣布，这款具有自主知识产权的URAT1抑制剂将为中国1.3亿高尿酸 血症患者带来新希望。 然而，近七年后，2025年8月13日，海创药业在发布年中财报的同时宣布了一则消息：拟暂停HP501项 目的研发推进。此时，该项目已投入募集资金8111.25万元。 决定背后的原因是残酷的市场竞争：国内已有药企针对URAT1靶点的产品获批上市，并有多项围绕该 靶点的Ⅲ期临床研究正在进行。 8月22日，海创药业方面在接受《中国经营报》记者采访时表示，募投项目子项目调整是基于公司实际 情况并结合当前市场竞争格局、行业发展趋势等多重因素决定的。上述调整将更好地维护公司和广大投 资者的利益，符合公司的长远发展及规划。不会对公司当期经营业绩产生重大影响，不存在损害股东利 益的情形。 从临床到落寞 据了解，HP501是海创药业自主研发的小分子化学创新药，为尿酸盐阴离子转运体1（URAT1）抑制 剂。临床前研究结果显示，其生物活性优于同类药物，展现了优良的药代动力学和毒理学性质。 ...

Group 1 - The company has approved a special report on the storage and actual use of raised funds for the first half of 2025, ensuring compliance with relevant regulations [7][17][46] - The total amount raised from the public offering was RMB 1,062,699,200, with a net amount of RMB 995,113,315 after deducting issuance costs [7][25] - As of June 30, 2025, the company has used RMB 871,447,067.89 of the raised funds, with a remaining balance of RMB 147,244,678.39 [8][9] Group 2 - The company has adjusted the investment projects related to the raised funds, specifically suspending further development of the HP501 project due to market competition [27][31] - The remaining funds from the "Innovative Drug R&D Project" will be redirected to ongoing projects HP518 and HP537 [27][30] - The adjustments are aimed at improving the efficiency of fund usage and aligning with the company's long-term strategic goals [31][33] Group 3 - The company has decided to cancel its supervisory board, with its functions being transferred to the audit committee of the board of directors [48][69] - Amendments to the company's articles of association have been proposed to align with the new Company Law and improve governance [49][80] - The company has also revised several internal governance documents to enhance management efficiency and compliance with updated regulations [81]

Industry Overview - Gout is a chronic disease caused by purine metabolism disorders, characterized by hyperuricemia and the deposition of urate crystals in joints and tissues, leading to various clinical symptoms [1][2] - The gout medication market in China has grown significantly, with the market size increasing from 700 million yuan in 2015 to 2.2 billion yuan in 2024 [1][10] - The prevalence of hyperuricemia in China is approximately 14%, with a patient population of around 197 million, while gout prevalence ranges from 1% to 3%, affecting approximately 15.5 to 42.29 million people [6][8] Market Dynamics - The gout medication market is primarily driven by the increasing incidence of gout and hyperuricemia due to lifestyle changes and dietary habits [10] - The market is currently experiencing a contraction due to the entry of mainstream gout medications like febuxostat into centralized procurement, but future growth is expected as patient numbers rise [10] - By 2030, the gout medication market in China is projected to exceed 10 billion yuan [10] Product Classification - Gout medications are categorized into acute anti-inflammatory analgesics and long-term urate-lowering drugs, with urate-lowering drugs accounting for about 40% of the global market [2][4] - In the domestic market, traditional drugs like febuxostat and benzbromarone hold a market share of approximately 60% [2] Competitive Landscape - The industry is characterized by intense competition, with generic drugs dominating the market while innovative drugs are rapidly being developed [14] - Major players include Kangyuan Pharmaceutical, Huahai Pharmaceutical, Yipinhong, and Hengrui Medicine, which are focusing on developing new urate-lowering agents to address the limitations of existing medications [14][15] - The introduction of centralized procurement policies has pressured generic drug prices, prompting companies to shift towards high-value innovative drugs [14] Key Companies - Hengrui Medicine is developing a new urate-lowering drug, SHR4640, which has shown significant efficacy and low toxicity, with a market application expected in 2025 [15][18] - Yipinhong is working on AR882, a new urate excretion promoter, which has received FDA support for global clinical trials [15] - Tonghua Dongbao has expanded its product pipeline in the gout treatment area, with two new drugs in clinical trials [16] Development Trends - The industry is shifting from generic to innovative drug development, with URAT1 inhibitors becoming a research focus [20] - Biologics and long-acting therapies are emerging as new growth points, with products like SEL-212 expected to enhance patient compliance and market potential [21] - Personalized treatment and combination therapies are becoming key research directions, aiming to meet unmet clinical needs [22]