Core Viewpoint - The application for market registration of HLX14, a biosimilar of denosumab developed by the company, has been accepted by the National Medical Products Administration (NMPA) in China, covering all indications approved for the reference drug Prolia in the region [1][2]. Group 1: Product Development and Approval - HLX14 is a biosimilar of denosumab, specifically a recombinant anti-RANKL fully human monoclonal antibody injection [1]. - The NDA for HLX14 is based on comparative studies demonstrating high similarity in quality, safety, and efficacy to the reference drug Prolia [1]. - The application includes indications for osteoporosis in postmenopausal women at high risk of fractures, osteoporosis in high-risk men, and glucocorticoid-induced osteoporosis [1]. Group 2: Market Potential - The global sales of denosumab products are projected to be approximately $7.463 billion in 2024 [2]. - HLX14 is expected to receive approval in the US, EU, and UK by the second half of 2025, covering all indications of its reference products [2]. - The application for HLX14 was also accepted by Health Canada in September 2024 [2].
复宏汉霖(02696)：地舒单抗生物类似药HLX14的上市注册申请获国家药品监督管理局受理