On 28 March 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency (EMA) has validated their marketing authorisation application (MAA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).
Henlius/Organon have previously had applications for HLX11 accepted by the US FDA (February 2025) and China’s Center for Drug Evaluation of the National Medical Products Administration (December 2024).
In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.