2 February 2025 - Shanghai Henlius Biotech announced that the US FDA has accepted the biologics license application for HLX11, an investigational biosimilar of Perjeta (pertuzumab).

Perjeta has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neo-adjuvant 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 Henlius press release