Fosun Pharma (02696.HK): The application for marketing registration of the biosimilar drug HLX14, a rituximab, has been accepted by the National Medical Products Administration.
Intelligence Finance App News, Fuhong Hanlin (02696.HK) announced that recently, the company's independently developed denosumab biosimilar HLX14 (recombinant anti-RANKL human monoclonal antibody injection) has had its New Drug Application (NDA) for market registration accepted by the National Medical Products Administration (NMPA). This NDA application includes all indications for the reference drug Prolia approved for marketing in China (excluding Hong Kong, Macau, and Taiwan), including: treatment of osteoporosis in postmenopausal women at high risk of fractures; significant reduction of the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women; treatment of osteoporosis in men at high risk of fractures; and treatment of glucocorticoid-induced osteoporosis at high risk of fractures.
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