Shanghai Fosun Pharmaceutical's subsidiary drug HLX319 has received approval for clinical trials.

Shanghai Fosun Pharmaceutical (600196.SH) announced that its holding subsidiary, Shanghai HENLIUS Biotech Co., Ltd. and its holding subsidiary ("HENLIUS") has received approval from the National Medical Products Administration for conducting Phase I clinical trials of HLX319 (trastuzumab/pertuzumab biosimilar injection for subcutaneous injection) for the adjuvant treatment of HER2-positive early or locally advanced breast cancer. HENLIUS plans to conduct relevant clinical studies of this drug in China when the conditions are met. HLX319 is a trastuzumab/pertuzumab biosimilar injection for subcutaneous injection developed independently by the group. It consists of the active ingredients pertuzumab monoclonal antibody, trastuzumab monoclonal antibody, and the excipient hyaluronidase (HLXTE-HAase02, a novel recombinant human hyaluronidase developed independently by the group), and is intended for the adjuvant/neoadjuvant treatment of early breast cancer and the treatment of metastatic breast cancer. As of February 2026, the group's cumulative investment in the research and development of HLX319 is approximately RMB 33.87 million (unaudited).