Core Viewpoint - The company has received FDA approval for its self-developed HLX15-SC, a subcutaneous injection of a recombinant anti-CD38 fully human monoclonal antibody, for the treatment of multiple myeloma, marking a significant milestone in its clinical development pipeline [1][2]. Group 1: Product Development - HLX15-SC is a biosimilar to Daratumumab, designed for treating multiple myeloma, which works by binding to CD38 on tumor cells and inducing apoptosis through various immune mechanisms [2]. - The company successfully completed a Phase I clinical study of HLX15-IV (intravenous formulation) in healthy male subjects in China in June 2024 [2]. - The IND application for HLX15-SC was approved by the National Medical Products Administration (NMPA) in February 2026 [2]. Group 2: Licensing and Commercialization - In February 2025, the company entered into a licensing agreement with Dr. Reddy's Laboratories Ltd., granting exclusive rights for the commercialization of HLX15 in the U.S. and specified European regions, including 42 countries [2]. Group 3: Market Potential - According to IQVIA MIDASTM, the global sales of Daratumumab are projected to be approximately $12.88 billion in 2024, indicating a substantial market opportunity for HLX15 [3].
复宏汉霖(02696)：HLX15-SC (重组抗CD38全人单克隆抗体注射液-皮下注射)用于多发性骨髓瘤治疗的1期临床试验申请获美国FDA批准