翰宇药业(300199.SZ)：醋酸格拉替雷注射液获得美国FDA批准证书

Core Viewpoint - The approval of the abbreviated new drug application for Acetate Glatiramer Injection by the U.S. FDA marks a significant milestone for the company, enhancing its product pipeline and market presence in the U.S. [1] Group 1: Product Information - Acetate Glatiramer is an immunomodulatory drug used for treating relapsing forms of multiple sclerosis (MS) [1] - The drug mimics the structure of myelin basic protein to regulate abnormal autoimmune responses, thereby reducing attacks on the central nervous system's myelin [1] - It is effective in lowering relapse frequency and delaying disease progression, suitable for patients with clinical isolated syndrome and relapsing-remitting multiple sclerosis [1] Group 2: Market Impact - The approval will enrich the company's overseas product pipeline and broaden its pharmaceutical market in the U.S. [1] - The company plans to actively promote the sales of this drug in overseas markets, which is expected to positively impact future performance and industry standing [1]