Shanghai Henlius Biotech's pertuzumab biosimilar HLX11 has received FDA acceptance of its Biologics License Application for HER2-positive breast cancer treatment, supported by comprehensive clinical trials.
HLX11, a biosimilar of Perjeta® (pertuzumab), met its primary endpoint in a Phase 3 clinical trial for HER2-positive, HR-negative early or locally advanced breast cancer.
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