Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) 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] Group 1: Product Approval - The product, SPH3127 tablets (also known as Apixaban), has been granted a drug registration certificate with the approval number H20250067 [1] - The approval signifies a significant milestone for the company in expanding its product portfolio in the hypertension treatment market [1] Group 2: Product Efficacy - SPH3127 tablets 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 [1] - Clinical research has demonstrated good overall safety and clear antihypertensive efficacy in patients with primary hypertension, fulfilling a clinical need for new treatment options [1] Group 3: Research and Development Investment - The company has invested approximately 296 million yuan in the research and development of SPH3127 tablets to date [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