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Shanghai Henlius Biotech’s Biosimilar Gains Regulatory Nod
This development positions the company to potentially capture a share of the RMB3.387 billion pertuzumab injection market in mainland China. The drug is aimed at treating HER2-positive breast ...
pharmaphorum4y
Roche claims EU okay for Herceptin/Perjeta combination Phesgo
and Perjeta (pertuzumab) in a subcutaneous injection that takes a few minutes to deliver. At the moment, Herceptin is available as a subcutaneous injection but Perjeta needs to be delivered by ...
JD Supra7d
FDA Accepts BLA for Shanghai Henlius Biotech’s HLX11, a Pertuzumab Biosimilar
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.