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长春高新控股子公司药品在美国获批上市
Group 1 - Changchun High-tech's subsidiary Brillian Pharma INC. received FDA approval for the oral solution of benzenesulfonic acid amlodipine, targeting hypertension in individuals aged 6 and above, as well as chronic stable angina and vasospastic angina in adults [1] - The prevalence of hypertension among adults in the U.S. was reported at 47.7% from August 2021 to August 2023, while the prevalence among children aged 6-17 was 3.8% [1] - Amlodipine is recommended as a first-line treatment for hypertension in children, aiming to reduce the risk of organ damage and cardiovascular diseases [1] Group 2 - The benzenesulfonic acid amlodipine oral solution is a 505B2 modified innovative drug developed for children over 6 and adults with swallowing difficulties, designed to lower blood pressure and reduce cardiovascular event risks [2] - The product is based on existing FDA-approved formulations, offering ease of use, accurate dosing, and palatability, which enhances medication adherence among pediatric patients [2] - The approval of this product is expected to strengthen Brillian Pharma's product portfolio in the U.S. market, enhancing the company's competitiveness in the pharmaceutical sector [2] Group 3 - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, received approval for the injection of Fushen Qibai monoclonal antibody, a new biological product for treating acute gouty arthritis in adults [3] - The company has diversified its business into various pharmaceutical segments, including gene engineering, biological vaccines, antibody drugs, and modern traditional Chinese medicine [3] Group 4 - The company is advancing clinical trials for several new drugs, including GenSci098 for thyroid eye disease and GenSci122 for advanced solid tumors, both of which have received FDA clinical trial permissions [4] - The company plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and international financing capabilities [4]