Core Viewpoint - The acceptance of the marketing registration application for HLX14, a biosimilar of denosumab by Fosun Pharma, marks a significant advancement in providing new treatment options for osteoporosis in China, following approvals in Europe and the US [1][3]. Group 1: Product Development and Market Position - Fosun Pharma's subsidiary, Fuhong Hanlin, has submitted a marketing registration application for HLX14, a biosimilar of denosumab, aimed at treating osteoporosis in postmenopausal women and men, as well as glucocorticoid-induced osteoporosis [1]. - The original denosumab, developed by Amgen, has generated over $7 billion in global sales, with a significant presence in the domestic market where it was approved around 2020 and included in the medical insurance directory [3]. - In 2024, the sales of denosumab in the domestic hospital market exceeded 1.8 billion yuan, reflecting a year-on-year growth rate of 57%, and in the first half of 2025, sales surpassed 1.4 billion yuan, with a growth rate of 79.05% [3]. Group 2: Competitive Landscape - The expiration of the original drug's patent has intensified competition in the domestic biosimilar market, with four companies, including Taikang Biopharma and Qilu Pharmaceutical, having received approvals for denosumab biosimilars [5]. - Several other companies, such as Maitaiabo and Haosen Pharmaceutical, are actively advancing their clinical trials for denosumab biosimilars, indicating a clearer competitive landscape in this sector [5]. Group 3: Investment and Future Outlook - As of October this year, Fosun Pharma has invested approximately 320 million yuan in the development of the denosumab injection product, and successful approval of this application could open new growth pathways for the company [11]. - The entry of more biosimilars and improved new drugs in the market is expected to enhance accessibility, treatment options, and long-term management for patients, ultimately benefiting a larger patient population [11].