氘泊替诺雷
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一品红:控股股东拟无偿转让Arthrosi 9.07%股权支持发展
Xin Lang Cai Jing· 2025-12-22 08:24
一品红公告称,公司第四届董事会第十五次会议审议通过《关于收到控股股东支持公司发展承诺暨关联 交易的议案》。基于对Arthrosi被并购交易及公司痛风创新药氘泊替诺雷大中华区市场和优先全球供应 的信心,控股股东广润集团将其子公司持有的Arthrosi 9.07%股权(Arthrosi E轮投后估值3.83亿美 元),无偿、无条件给公司,支持创新发展。该事项构成关联交易,已申请豁免提交股东会审议。关联 董事李捍雄、李捍东回避表决,议案获3票同意通过。 ...
一品红同日公告三款药品获批 儿童药和慢病药管线持续扩充
Zheng Quan Shi Bao Wang· 2025-12-01 01:52
Core Insights - The company Yipinhong (300723) has received approval for three new drugs from the National Medical Products Administration, enhancing its product pipeline in the pediatric and chronic disease medication sectors [1][2] Drug Approvals - The three approved drugs include: - Esomeprazole magnesium enteric-coated suspension, indicated for gastroesophageal reflux disease and H. pylori eradication, with a projected sales scale of approximately 2.243 billion yuan in 2024 [1] - Ketoconazole sustained-release tablets, aimed at peripheral vascular diseases, with an expected sales scale of around 1.426 billion yuan in 2024 [1] - Compound polyethylene glycol (3350) electrolyte powder, for treating chronic constipation in children, with a projected sales scale of about 1.108 billion yuan in 2024 [2] Market Positioning - The approval of these drugs signifies the company's qualification to market these products domestically, thereby enriching its offerings in the pediatric and chronic disease medication fields and enhancing its competitive edge [2] Recent Developments - A week prior, the company announced the approval of a drug for treating mild to moderate Alzheimer's symptoms, with an expected sales scale of approximately 100 million yuan in 2024 [2] - The company is also advancing its innovative gout drug, AR882, which has completed the target enrollment of 680 patients in its domestic Phase III clinical trial [2][3] Clinical Trial Results - Data from completed global Phase II trials for AR882 indicate effective reduction of serum uric acid (sUA) and high rates of complete dissolution of gout stones in patients, providing a promising oral treatment option for chronic gout patients [3]
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]