Shanghai Henlius Biotech and Organon (OGN) announced that the European Medicines Agency has validated the marketing authorization application for HLX11, an investigational biosimilar of Perjeta. Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer, and adjuvant treatment for certain HER2-positive early breast cancer, among other indications.
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