Shanghai Henlius Biotech announced on 2 February 2025 that the US FDA has accepted its Biologics Licence Application (BLA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).
The US acceptance of Henlius’ BLA follows the December 2024 acceptance of its NDA for HLX11 by China’s Center for Drug Evaluation of the National Medical Products Administration.
In June 2022, Shanghai 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.