HENLIUS (02696) announced that the Investigational New Drug application for a Phase 1 clinical trial of its self-developed subcutaneous biosimilar HLX319 has been approved by the National Medical Products Administration. The company plans to initiate the related clinical trial in China once conditions are met. HLX319 is a biosimilar of pertuzumab and trastuzumab injection for subcutaneous use. It consists of the active ingredients trastuzumab and pertuzumab, along with the excipient hyaluronidase (HLXTEHAase02, a novel recombinant human hyaluronidase developed by the company). The product is intended for the adjuvant/neoadjuvant treatment of early breast cancer and the treatment of metastatic breast cancer. The subcutaneous formulation is a fixed-dose combination of trastuzumab and pertuzumab that targets different epitopes of HER2, synergistically blocking HER2 signaling and mediating antibody-dependent cellular cytotoxicity to exert anti-tumor effects. Trastuzumab specifically binds to domain IV of the HER2 extracellular region, inhibiting tumor cell proliferation and mediating ADCC. Pertuzumab binds to domain II, preventing HER2 from dimerizing with other ErbB family members, leading to cell growth arrest and apoptosis, while also mediating ADCC. In accordance with China's biosimilar guidelines and referencing those of the EU and US, comparative pharmaceutical studies, preclinical pharmacodynamics, pharmacokinetics, and toxicology research have demonstrated that HLX319 is highly similar to the reference product. According to data from IQVIA MIDAS™, global sales of the reference subcutaneous pertuzumab and trastuzumab injection are projected to reach approximately $3.023 billion by 2025.
Comments