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 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]