Core Viewpoint - The approval of Brillian Pharma INC.'s product, a freeze-dried powder for oral solution of Amlodipine Besylate, by the FDA enhances the company's product portfolio in the U.S. market and strengthens its competitive position in the pharmaceutical industry [1][3]. Group 1: Product Information - Product Name: Amlodipine Besylate Oral Solution Freeze-Dried Powder - Brand Name: Sdamlo - Approved Indications: For hypertension in individuals aged 6 and older, and for chronic stable angina, vasospastic angina, and coronary artery disease confirmed by angiography [1][2]. Group 2: Market Context - Hypertension is a chronic condition characterized by persistently elevated arterial blood pressure, affecting 47.7% of U.S. adults aged 18 and older and 3.8% of children aged 6-17 as of August 2023 [2]. - Amlodipine is recommended as a first-line treatment for hypertension in children and adolescents, aiming to reduce the risk of organ damage and cardiovascular diseases [2]. Group 3: Impact on the Company - The product's approval will enrich Brillian Pharma's product offerings in the U.S. and enhance its competitiveness in the pharmaceutical market [3]. - The company plans to actively promote, produce, and sell the product, aiming for widespread market application and providing more treatment options for patients [3].
长春高新技术产业(集团)股份有限公司关于境外子公司苯磺酸氨氯地平口服溶液用冻干粉在美国获批上市的公告