海南海药(000566.SZ):注射用美罗培南通过仿制药质量和疗效一致性评价

Core Viewpoint - Hainan Haiyao's subsidiary has received approval for the injectable antibiotic Meropenem, which is a broad-spectrum carbapenem antibiotic effective against various bacterial infections [1] Group 1: Company Developments - Hainan Haiyao's wholly-owned subsidiary, Haikou Pharmaceutical Factory, has obtained the approval from the National Medical Products Administration for the supplemental application of injectable Meropenem [1] - Meropenem is an artificially synthesized broad-spectrum carbapenem antibiotic that inhibits bacterial cell wall synthesis [1] Group 2: Product Characteristics - Meropenem is effective against most Gram-positive and Gram-negative bacteria by penetrating their cell walls to reach the target penicillin-binding proteins (PBPs) [1] - The antibiotic shows strong stability against most beta-lactamases, including those produced by both Gram-positive and Gram-negative bacteria [1] Group 3: Indications for Use - Injectable Meropenem is primarily indicated for infections in adults and children caused by single or multiple bacteria sensitive to Meropenem, including pneumonia, urinary tract infections, intra-abdominal infections, gynecological infections, skin and soft tissue infections, meningitis, and sepsis [1]