长春高新：苯磺酸氨氯地平口服溶液用冻干粉获FDA批准上市

Group 1 - Changchun High-tech announced that its subsidiary Brillian Pharma INC. received FDA approval for the oral solution of benidipine hydrochloride lyophilized powder, which is suitable for treating hypertension in patients aged 6 and above, as well as chronic stable angina and vasospastic angina in adults [1][2] - The approved product is a 505B2 modified innovative drug specifically designed for children over 6 years old and adults with swallowing difficulties, aimed at lowering blood pressure and reducing the risk of fatal and non-fatal cardiovascular events [1] - The product is developed based on existing FDA-approved original products, offering convenience in clinical use, accurate dosing, and palatable taste, enhancing medication adherence for pediatric patients [1] Group 2 - The approval of this product will enrich Brillian Pharma's product portfolio in the U.S. market and enhance the company's competitiveness in the pharmaceutical sector [2] - The company plans to actively organize market promotion, production, and sales efforts to facilitate the widespread application of the product, providing more treatment options for patients [2]