Zheng Quan Zhi Xing·2025-09-01 16:18Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its biosimilar drug HLX14, which is a formulation of denosumab [1][3]. Product Information - HLX14 is developed as a biosimilar to treat osteoporosis in postmenopausal women at high risk of fractures and other indications consistent with the reference drug [3]. - The approved products include: - BILDYOS (60 mg/mL) for increasing bone mass in men with non-metastatic prostate cancer and women with breast cancer at high risk of fractures [2]. - BILPREVDA (120 mg/1.7mL) for treating patients with giant cell tumors and refractory hypercalcemia due to malignancy [2]. Market Impact - The approval of BILDYOS and BILPREVDA will enhance the product line of the group and strengthen its international market presence [3]. - As of September 1, 2025, Fuhong Hanlin has three products approved for the U.S. market, indicating a growing portfolio [3]. Financial Insights - The cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) as of July 2025 [3]. - The global sales of denosumab injection products are projected to be around $7.462 billion in 2024 [3]. Licensing Agreement - The commercialization rights for HLX14 outside of China and Hong Kong were granted to Organon LLC in June 2022, allowing Fuhong Hanlin to earn milestone payments and sales royalties [4].