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 Insights - Shanghai Pharmaceuticals (02607) announced that its subsidiary, Shanghai Shenyin Pharmaceutical Factory, received the drug registration certificate for SPH3127 (also known as Apixaban) from the National Medical Products Administration [1][2] - SPH3127 is a new generation oral non-peptide small molecule renin inhibitor, designed to treat primary hypertension by directly inhibiting renin, counteracting the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - Clinical studies have shown that SPH3127 has a good overall safety profile and significant antihypertensive efficacy in patients with primary hypertension, providing a new treatment option for this patient group [1] Company Developments - The approval of SPH3127 marks Shanghai Shenyin's qualification to produce and sell the drug in the domestic market [2] - The company emphasizes the importance of drug research and development, maintaining strict quality and safety controls throughout the drug development, manufacturing, and sales processes [2] - The total research and development investment for SPH3127 has reached approximately 296 million yuan [1]

Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) has received approval from the National Medical Products Administration for its new drug, SPH3127 tablets, which are a new generation of oral non-peptide small molecule renin inhibitors for the treatment of primary hypertension [1] Company Summary - The drug SPH3127 is designed to directly inhibit renin, counteracting the increase in blood pressure caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - The approval of SPH3127 represents a significant advancement in the company's product offerings in the hypertension treatment market [1] Industry Summary - The approval of new hypertension treatments like SPH3127 reflects ongoing innovation in the pharmaceutical industry, particularly in the development of targeted therapies for cardiovascular conditions [1] - The introduction of non-peptide small molecule inhibitors may enhance treatment options for patients with primary hypertension, potentially impacting market dynamics [1]

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] Company Summary - The approved drug, SPH3127, is designed to directly inhibit renin, counteracting the blood pressure increase caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - Clinical studies have demonstrated that SPH3127 shows a clear antihypertensive effect in patients with primary hypertension, providing a new treatment option for this patient group [1] - The total research and development investment for SPH3127 has reached approximately 296 million yuan [1] Industry Summary - SPH3127 is positioned as a next-generation treatment in the hypertension market, with stronger renin activity inhibition compared to existing drugs targeting the same pathway [1] - The drug has shown efficacy in models of hypertension, chronic kidney disease, and inflammatory bowel disease, indicating its potential broader therapeutic applications [1]

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]

Core Viewpoint - Shanghai Pharmaceuticals 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] Company Summary - The drug, SPH3127 tablets, is designed to directly inhibit renin, counteracting the blood pressure increase caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - Clinical studies have demonstrated that SPH3127 tablets exhibit a clear antihypertensive effect in patients with hypertension, indicating good overall safety and efficacy [1] - The total research and development investment for SPH3127 tablets has reached approximately 296 million yuan [1] Industry Summary - SPH3127 tablets represent a new treatment option for patients with primary hypertension, addressing an unmet clinical need in this patient population [1] - The drug has shown stronger renin activity inhibition compared to other drugs targeting the same pathway, as evidenced by both in vitro and in vivo pharmacological studies [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607) announced that its subsidiary, Shanghai Pharmaceuticals Xinyi, received a drug registration certificate from the National Medical Products Administration for the approval of its application for the marketing license of Apixaban Tablets, a new generation of oral non-peptide small molecule renin inhibitors [1] Group 1 - The approved drug, Apixaban Tablets, directly inhibits renin, counteracting the increase in blood pressure caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - The drug is indicated for the treatment of primary hypertension [1]

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]