复宏汉霖(02696.HK):地舒单抗生物类似药“HLX14”的上市注册申请获药监局受理
Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has announced that its self-developed biosimilar HLX14 has had its New Drug Application (NDA) accepted by the National Medical Products Administration (NMPA) in China, which includes all indications approved for the reference drug Prolia® [1] Group 1 - The NDA submission for HLX14 includes indications for osteoporosis in postmenopausal women at high risk of fractures [1] - The drug significantly reduces the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women [1] - HLX14 is also indicated for osteoporosis in high-risk men and for glucocorticoid-induced osteoporosis [1]