Shanghai Henlius Biotech, Inc. and Organon   announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application (MAA) for HLX11, an investigational biosimilar of Pertuzumab. Pertuzumab has been approved in multiple countries and regions for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer, as well as adjuvant therapy for certain HER2-positive early-stage breast cancers.^®

The application is based on a multicenter, randomized, double-blind, parallel-controlled, Phase 3 clinical study (NCT05346224) comparing the efficacy and safety of HLX11 with the comparator pajet (pertuzumab) as neoadjuvant therapy in combination with a complete regimen in patients with HER2-positive, HR-negative early-stage or locally advanced breast cancer. HLX11 met the primary endpoint of overall pathologic complete response (tpCR) rate as assessed by an independent review committee (IRC). Other secondary endpoints were also comparable between the two groups. ^®

In 2022, Henlius entered into a licensing and supply agreement with Organon granting Organon exclusive commercialization rights to two biosimilar product candidates, including HLX11. The agreement covers markets such as the United States, the European Union and Canada. China is not included in the agreement.