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马来酸依那普利片(5mg)
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国药现代:关于药品通过仿制药一致性评价的自愿性信息披露公告
Zheng Quan Ri Bao· 2025-09-17 13:36
Core Points - The company Guoyao Modern has received approval from the National Medical Products Administration for the drug Enalapril Maleate Tablets (5mg) to pass the consistency evaluation of generic drug quality and efficacy [2] Group 1 - Guoyao Modern announced the receipt of the approval notice for the supplementary application of the drug [2] - The approval indicates that the drug has met the standards for quality and efficacy consistency as a generic medication [2]
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
Sou Hu Cai Jing· 2025-09-17 09:46
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]
国药现代:马来酸依那普利片(5mg)通过仿制药一致性评价
Guo Ji Jin Rong Bao· 2025-09-17 08:29
Core Viewpoint - The company has received approval from the National Medical Products Administration for the supplementary application of Maleate Enalapril Tablets (5mg), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval and Market Potential - The approval allows for the expansion of the product's market and sales potential, with projected sales in 2024 for the drug estimated at RMB 164 million in public medical institutions and urban pharmacies [1] - The company has invested approximately RMB 15.3657 million in the research and development of this project [1] Group 2: Product Information - Maleate Enalapril Tablets are an angiotensin-converting enzyme inhibitor primarily used for treating primary hypertension, renovascular hypertension, and symptomatic heart failure [1] - The company’s Maleate Enalapril Tablets (10mg) had already passed the consistency evaluation in January 2022, indicating a strong foundation for the new 5mg formulation [1]