FOSUN PHARMA (600196.SH) announced that its subsidiary Shanghai Henlius Biotech, Inc. and its controlled entities recently obtained approval from the National Medical Products Administration. The approval permits Phase I clinical trials of HLX319, a biosimilar of pertuzumab and trastuzumab injection for subcutaneous use, for neoadjuvant treatment of HER2-positive early or locally advanced breast cancer. Henlius plans to conduct related clinical studies in China once conditions are met. HLX319 is a biosimilar independently developed by the group, composed of active ingredients trastuzumab and pertuzumab, along with the excipient hyaluronidase (HLXTE-HAase02, a novel recombinant human hyaluronidase developed by the group). It is intended for adjuvant/neoadjuvant treatment of early breast cancer and treatment of metastatic breast cancer. As of February 2026, the group's cumulative R&D investment in HLX319 amounts to approximately RMB 33.87 million (unaudited).