HLX319 (trastuzumab/pertuzumab SC biosimilar) / Shanghai Henlius Biotech, Fosun Pharma - LARVOL DELTA

FACET: Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • PGR

Shanghai Henlius Biotech has begun dosing participants in a phase 1 clinical trial in mainland China for HLX319, a subcutaneous biosimilar combination of pertuzumab and trastuzumab designed for HER2-positive breast cancer (TipRanks) - "The randomized, double-blind study in healthy Chinese male subjects compares pharmacokinetics, safety, tolerability and immunogenicity of HLX319 with Phesgo, its European reference product."

Trial status • HER2 Positive Breast Cancer

Fosun Pharma…announced that the National Medical Products Administration (NMPA) has approved the Phase 1 clinical trial application (INDs) for its independently developed biosimilar injection HLX319 (subcutaneous injection) of pertuzumab-trastuzumab. (iis.aastocks.com)

New P1 trial • Breast Cancer • HER2 Positive Breast Cancer