By Fineline Cube 
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Roche’s Perjeta (pertuzumab). This validation marks a significant step toward the potential approval and commercialization of HLX11 in key markets.
Partnership Details
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon exclusive commercialization rights to HLX11 and another biosimilar candidate. The agreement covers major markets including the United States, the European Union, and Canada, with China excluded from the deal.
Clinical Trial Success
The MAA submission is based on a robust Phase III clinical study (NCT05346224), which compared HLX11 with reference Perjeta in patients with HER2-positive, HR-negative early-stage or locally advanced breast cancer. The study met its primary endpoint of total pathological complete response (tpCR) rate, as assessed by an Independent Review Committee (IRC), and demonstrated comparable safety profiles between the two groups.-Fineline Info & Tech