上海医药（601607）(02607)发布公告，近日，公司下属上海上药信谊药厂有限公司(上药信谊)收到国家 药监局下发的《药品注册证书》(药品批准文号：国药准字H20250067)，由其提交的苹果酸司妥吉仑片 (即SPH3127片)的药品上市许可申请获国家药监局批准。 苹果酸司妥吉仑片是新一代口服非肽类小分子肾素抑制剂，通过对肾素的直接抑制，拮抗由肾素-血管 紧张素-醛固酮系统(RAAS)过度激活造成的血压上升，适用于原发性高血压的治疗。体外和体内药效学 研究均表明，苹果酸司妥吉仑片比同靶点药物具有更强的肾素活性抑制作用，并且在高血压、慢性肾病 和炎症性肠病模型中证实了其药效学特征。已完成的临床研究表明，苹果酸司妥吉仑片总体安全性良 好，在高血压患者人群中显示出了明确的降压疗效，能够进一步满足原发性高血压患者的临床需求，为 原发性高血压患者提供一种新的治疗选择。截止目前，苹果酸司妥吉仑片相关项目累计已投入研发费用 约2.96亿元。 本次苹果酸司妥吉仑片(即SPH3127片)获得上市许可标志着上药信谊具备在国内市场生产和销售该药品 的资格。同时，公司高度重视药品研发，并严格控制药品研发、制造及销售环节的质量及安 ...

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]

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]