痛风创新药

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一品红创新原料药基地获批药品生产许可证 全球1类创新药AR882全球入组上千人
Zheng Quan Shi Bao Wang· 2025-05-30 05:05
Core Viewpoint - The company has successfully obtained the production license for the innovative gout drug AR882, indicating that its production capabilities meet national drug standards and regulatory requirements, which supports the drug's future market launch [1] Group 1: Company Developments - The subsidiary Guangdong Ruishi Pharmaceutical Technology Co., Ltd. has passed the comprehensive review by the Guangdong Provincial Drug Administration and obtained the production license for the active pharmaceutical ingredient (API) deuterated probenecid (AR882) [1] - The innovative API base of Ruishi Pharmaceutical is designed according to international standards such as FDA and EU GMP, covering an area of 110 acres with over 50,000 square meters of constructed area and multiple advanced production lines [1] - The production workshop for AR882 utilizes fully enclosed automated production equipment, achieving industry-leading standards in China [1] Group 2: Product Information - AR882 is a next-generation, highly selective URAT1 inhibitor that promotes uric acid excretion and prevents renal toxicity, with a once-daily dosage to maintain healthy serum uric acid levels [2] - The drug has received Fast Track Designation (FTD) from the FDA for gout stone research, potentially filling a global gap in oral medications for gout stone treatment [2] - The global prevalence of hyperuricemia and gout is projected to reach 1.42 billion by 2030, with approximately 200 million individuals affected in China, indicating a significant clinical demand for effective treatments [2] Group 3: Clinical Progress - AR882 has enrolled over a thousand participants globally in its Phase III clinical trials, showing promising efficacy in three key areas: precise acid control, dissolution of gout stones, and safety without renal toxicity [3] - The company has agreed to acquire the remaining 15.25% stake in its subsidiary Guangzhou Ruianbo from Arthrosi for approximately 6.8 million USD, increasing its ownership to 100% to enhance its market position for AR882 in China [3]