Core Viewpoint - Changchun High-tech has received FDA approval for its subsidiary Brillian Pharma INC.'s formulation of Amlodipine Besylate oral solution, targeting hypertension in children aged 6 and above and adults, enhancing the company's product portfolio in the U.S. market [1][2] Group 1: Product Approval and Indications - The FDA has approved the Amlodipine Besylate oral solution for treating hypertension in individuals aged 6 and older, as well as chronic stable angina and vasospastic angina in adults [1] - Hypertension affects 47.7% of U.S. adults aged 18 and older, and 3.8% of children aged 6-17, highlighting a significant market need for effective treatments [1] Group 2: Product Features and Benefits - The Amlodipine Besylate oral solution is a 505B2 modified innovative drug designed for children and adults with swallowing difficulties, aimed at reducing blood pressure and cardiovascular event risks [2] - The product is developed based on existing FDA-approved formulations, ensuring ease of use, accurate dosing, and palatable taste, which enhances adherence among pediatric patients [2] - The formulation can be stored at room temperature without the need for cold chain logistics, ensuring safety and accuracy in clinical use [2] Group 3: Market Strategy and Outlook - The approval of this product is expected to enrich Brillian Pharma's product offerings in the U.S. market and strengthen the company's competitive position in the pharmaceutical sector [2] - The company plans to actively promote, produce, and sell the product, aiming for widespread market application and providing more treatment options for patients [2]