白云山(00874)分公司获得药品补充申请批件
智通财经网·2025-12-29 11:06

Core Viewpoint - The company Baiyunshan Pharmaceutical Group has received approval from the National Medical Products Administration for its injectable Cefuroxime Sodium, enhancing its market competitiveness [1] Group 1: Product Approval - Baiyunshan Pharmaceutical's subsidiary received a notification of approval for a supplementary application for injectable Cefuroxime Sodium [1] - The product was officially launched in China in May 2006 and submitted for consistency evaluation in April 2025 [1] Group 2: Product Characteristics - Cefuroxime Sodium is a second-generation cephalosporin effective against a wide range of Gram-negative and Gram-positive bacteria, with advantages such as a broad antibacterial spectrum, lower renal toxicity, and stability against β-lactamase [1] - It is widely used in clinical settings for treating respiratory infections, urinary tract infections, and surgical infections [1] Group 3: Market Position - Injectable Cefuroxime Sodium is included in the National Essential Medicines List (2018) and is classified as a Category B drug under the National Medical Insurance (2025) [1] - The successful completion of the consistency evaluation for the generic drug is expected to enhance the product's market competitiveness [1]