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国药现代最新公告:马来酸依那普利片(5mg)通过仿制药一致性评价

Core Viewpoint - The company, China National Pharmaceutical Group Modern (国药现代), has received approval from the National Medical Products Administration for the supplementary application of Enalapril Maleate Tablets (5mg), which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Product Information - Enalapril Maleate Tablets are an angiotensin-converting enzyme (ACE) inhibitor primarily used for treating essential hypertension, renovascular hypertension, and symptomatic heart failure [1] - The projected sales for Enalapril Maleate Tablets in public medical institutions and urban pharmacies in China for 2024 is estimated at RMB 164 million [1] Group 2: Financial Investment - The cumulative R&D investment for this project amounts to approximately RMB 15.37 million (unaudited) [1] - The approval of the 5mg formulation is expected to facilitate future market expansion and sales of the product [1] Group 3: Impact on Company Performance - The recent approval is not anticipated to have a significant impact on the company's current operating performance [1]