Shanghai Henlius Biotech, Inc. and Organon announced on March 28, 2025, that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11. HLX11 is an investigational biosimilar of Perjeta (pertuzumab).
The submission is based on a multicenter, randomized, double-blind, parallel-controlled Phase 3 clinical study (NCT05346224). This study compared the efficacy and safety of HLX11 with reference Perjeta as a neoadjuvant therapy in patients with HER2-positive, HR-negative early-stage, or locally advanced breast cancer.
HLX11 met its primary endpoint, the total pathological complete response (tpCR) rate, as assessed by an Independent Review Committee. Organon holds exclusive commercialization rights for HLX11 in markets including the United States, the European Union, and Canada, under a 2022 license and supply agreement with Henlius.
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