SHR-1309

SHR-1309 is a biosimilar candidate of pertuzumab, a recombinant humanized monoclonal antibody developed by Shanghai Hengrui Pharmaceutical. It targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 (HER2). By binding to HER2, it inhibits the heterodimerization of HER2 with other HER family members, particularly HER3, thereby blocking downstream signaling pathways such as MAPK and PI3K/Akt that promote cell proliferation and survival. SHR-1309 is primarily being developed for the treatment of HER2-positive breast cancer, including early and metastatic stages. Clinical development includes Phase 1 pharmacokinetic equivalence studies comparing it to the reference product, Perjeta.

Other names

pertuzumab biosimilar