28 March 2025 - -Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation application for HLX11, an investigational biosimilar of Perjeta (pertuzumab). 

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.

Read Shanghai Henlius press release