福森药业:“盐酸尼卡地平注射液”一致性评价申请获批上市

Core Viewpoint - Fosen Pharmaceutical has received approval from the National Medical Products Administration of China for its "Nicardipine Hydrochloride Injection," which is intended for emergency treatment of abnormal hypertension during surgery and hypertensive emergencies [1][2] Group 1: Product Approval and Market Potential - The approval of Nicardipine Hydrochloride Injection is significant as it is recommended in various hypertension management guidelines, including the 2020 International Society of Hypertension's Global Hypertension Practice Guidelines and the Chinese Hypertension Emergency Diagnosis and Treatment Guidelines [1][2] - The sales scale of Nicardipine Hydrochloride Injection in Chinese public medical institutions is projected to exceed 600 million RMB in 2024, with a double-digit growth rate from 2022 to 2024, showing year-on-year increases of 35.71%, 16.09%, and 14.14% respectively [1] Group 2: Product Advantages and Market Position - Nicardipine Hydrochloride Injection is characterized by rapid onset, stable blood pressure reduction, and comprehensive organ protection, with non-toxic metabolites and enhanced vascular selectivity, making it safer for patients [2] - Fosen Pharmaceutical offers a complete range of specifications for Nicardipine Hydrochloride Injection, including 5ml:5mg, 2ml:2mg, and 10ml:10mg, catering to diverse patient treatment needs and achieving high market recognition [2] - The quality and efficacy of Fosen Pharmaceutical's Nicardipine Hydrochloride Injection are consistent with reference formulations, allowing it to serve as a substitute for the original drug in clinical settings [2]