石药集团:美沙拉秦肠溶片获药品注册批件

Core Viewpoint - The approval of Mesalazine enteric-coated tablets (0.5g) by the National Medical Products Administration of the People's Republic of China marks a significant advancement for the company in the field of immunotherapy products, enhancing its product line in this area [1] Group 1: Product Approval - The company has received a drug registration certificate for Mesalazine enteric-coated tablets, which is considered equivalent to passing the consistency evaluation of generic drug quality and efficacy [1] - This product is primarily used for the treatment of ulcerative colitis, including both acute episodes and maintenance therapy to prevent recurrence, as well as for the treatment of acute episodes of Crohn's disease [1] Group 2: Mechanism of Action - Mesalazine works by regulating inflammatory indicators in the intestinal mucosa, inhibiting the synthesis of prostaglandins and the formation of inflammatory mediators such as leukotrienes, thereby achieving its anti-inflammatory effects [1] - The product demonstrates significant inhibitory effects on inflammation in the intestinal wall connective tissue, making it a widely used aminosalicylate anti-inflammatory drug globally [1] Group 3: Market Impact - The approval of this product will further enrich the company's product line in the immunotherapy sector, potentially increasing its market presence and competitiveness in the pharmaceutical industry [1]