Workflow
氘泊替诺雷
icon
Search documents
一品红痛风创新药氘泊替诺雷(AR882)原创性研究亮相EULAR 2025年会
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]
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
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]
一品红: 关于全资子公司取得药品生产许可证的公告
Zheng Quan Zhi Xing· 2025-05-28 08:17
Core Viewpoint - Yipinhong Pharmaceutical Group Co., Ltd. has recently obtained a drug production license for its wholly-owned subsidiary, Guangdong Ruishi Pharmaceutical Technology Co., Ltd., marking a significant milestone in its new drug development process [1]. Group 1: Drug Production License Details - The drug production license was issued by the Guangdong Provincial Drug Administration [1]. - The license is valid until May 21, 2030, and pertains to the production of the raw material drug, Deutetrabenazine [1]. - The production facility is located in the manufacturing industrial park in Wengyuan County, Shaoguan City, Guangdong Province [1]. Group 2: Impact on the Company - The acquisition of the drug production license is not expected to have a significant impact on the company's current performance, as commercial production can only commence after obtaining the drug marketing approval number [1]. - The license represents a milestone in the new drug research and development process, but there are uncertainties regarding the subsequent clinical trial phases and the ability to obtain production permits and market qualifications [1]. - The company will actively promote the related R&D projects and fulfill its information disclosure obligations regarding the project's progress [1].