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On February 2, 2025, Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentech’s PERJETA.  This marks the first U.S. BLA acceptance for a pertuzumab biosimilar, a targeted therapy for select patients with HER2-positive breast cancer.

Pertuzumab is currently indicated by the FDA for use in