Core Viewpoint - The first domestically developed Dazhu single antibody from China has successfully received approval from the US FDA for market entry, marking a significant milestone for the company and the industry [1] Company Summary - The company, Fuhong Hanlin, announced that its Dazhu single antibody injection products (60mg/mL and 120mg/1.7mL) have been approved by the US FDA for the treatment of osteoporosis and eight other indications [1] - This approval represents the first instance of a domestically produced Dazhu single antibody being approved for sale overseas [1] - Currently, Fuhong Hanlin has three products approved in the United States [1] Industry Summary - The approval of a Chinese-developed drug by the US FDA highlights the growing capabilities and competitiveness of the Chinese biopharmaceutical industry in the global market [1] - The successful entry of this product into the US market may pave the way for further international approvals of Chinese-developed drugs, enhancing the industry's reputation and potential for growth [1]
首款“中国籍”地舒单抗成功出海，获美国FDA批准上市