Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the marketing license of SPH3127 tablets, a new oral non-peptide small molecule renin inhibitor for the treatment of primary hypertension [1][2] Group 1: Product Approval and Characteristics - The approval of SPH3127 tablets allows Shanghai Pharmaceuticals to produce and sell the drug in the domestic market [2] - SPH3127 is designed to directly inhibit renin, counteracting the blood pressure increase caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - Preclinical and clinical studies indicate that SPH3127 exhibits stronger renin activity inhibition compared to other drugs targeting the same pathway, demonstrating efficacy in models of hypertension, chronic kidney disease, and inflammatory bowel disease [1] Group 2: Clinical Efficacy and Safety - Completed clinical research shows that SPH3127 has good overall safety and clear antihypertensive effects in patients with primary hypertension [1] - The drug aims to meet the clinical needs of primary hypertension patients by providing a new treatment option [1] Group 3: Research and Development Investment - The cumulative research and development investment for SPH3127 has reached approximately 296 million yuan [1]
上海医药:苹果酸司妥吉仑片(SPH3127 片)上市许可申请获得批准