首款“中国籍”地舒单抗成功出海 获美国FDA批准上市
Core Viewpoint - The approval of two products of Dazhu Single Antibody Injection by the FDA marks a significant milestone for the company, being the first domestically produced Dazhu Single Antibody to be approved overseas [2] Company Summary - The company, Fuhong Hanlin, has announced that its Dazhu Single Antibody Injection products (60mg/mL and 120mg/1.7mL) have received FDA approval for eight indications, including osteoporosis and bone-related events [2] - With this approval, the company now has three products approved in the United States [2]