上海医药(02607):苹果酸司妥吉仑片(SPH3127 片)上市许可申请获得批准
智通财经网·2025-12-10 09:40

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]

Shanghai Pharma-上海医药(02607):苹果酸司妥吉仑片(SPH3127 片)上市许可申请获得批准 - Reportify