苹果酸司妥吉仑片(SPH3127片)
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上海医药:苹果酸司妥吉仑片(SPH3127 片)上市许可申请获得批准
Zhi Tong Cai Jing· 2025-12-10 09:44
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
Ge Long Hui· 2025-12-10 07:56
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)上市许可申请获批准
Xin Lang Cai Jing· 2025-12-10 07:56
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for its new drug, SPH3127 tablets, which are indicated for the treatment of primary hypertension [1] Group 1: Company Developments - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyin Pharmaceutical Factory, has been granted a drug registration certificate for SPH3127 tablets [1] - The drug is a new generation oral non-peptide small molecule renin inhibitor [1] Group 2: Industry Context - SPH3127 tablets work by directly inhibiting renin, counteracting the blood pressure increase caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - The drug is specifically designed for the treatment of primary hypertension [1]