Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received approval from the National Medical Products Administration for the marketing license of its new drug, SPH3127 tablets, which is a novel oral non-peptide small molecule renin inhibitor for the treatment of primary hypertension [1] Group 1: Drug Approval and Characteristics - The drug name is SPH3127 tablets, with the application acceptance number CXHS2400037 [1] - 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 studies show that SPH3127 has good overall safety and clear antihypertensive efficacy in patients with hypertension [1] - The drug aims to meet the clinical needs of patients with primary hypertension by providing a new treatment option [1] Group 3: Research and Development Investment - To date, approximately 296 million yuan has been invested in the research and development of SPH3127 [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