Phesgo® is the official global commercial brand name, and Hishuangyi is its Chinese brand developed by Roche. It is a fixed-dose combination subcutaneous formulation of pertuzumab and trastuzumab. The two monoclonal antibodies bind to different epitopes of HER2 receptor, block HER2 dimerization and downstream oncogenic signaling pathways, mediate antibody-dependent cellular cytotoxicity, and inhibit the proliferation of HER2-positive tumor cells.
Main Indications
Neoadjuvant therapy for adult patients with locally advanced, inflammatory or early HER2-positive breast cancer;
Adjuvant therapy for adult patients with high-risk HER2-positive early breast cancer;
Combined with docetaxel as first-line treatment for adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
Clinical Research
Global multicenter phase III FeDeriCa pivotal trial validated that subcutaneous fixed-dose Phesgo achieved non-inferior systemic drug exposure and equivalent anti-tumor efficacy compared with intravenous pertuzumab plus trastuzumab;
Phase III PHranceSCa trial proved similar clinical outcomes, drastically shortened administration time and higher patient preference for subcutaneous regimen;
Long-term follow-up data confirmed consistent long-term disease control and comparable cardiac safety profile with repeated subcutaneous administration;
Dose exploration studies confirmed reliable efficacy and acceptable local injection-site tolerance of the 600mg pertuzumab / 600mg trastuzumab maintenance dose;
Chinese registration trials verified consistent anti-tumor activity and manageable safety profile in domestic HER2-positive breast cancer patients.
Common Side Effects
Common mild adverse reactions: Alopecia, diarrhea, nausea, fatigue, anemia, injection site reactions and rash;
Laboratory abnormalities: Transient leukopenia, neutropenia and reduced hemoglobin;
Severe but uncommon risks: Symptomatic congestive heart failure, severe hypersensitivity reactions, febrile neutropenia and pulmonary adverse events.
Approval Status in China
Original drug Phesgo® obtained marketing approval in China in 2022. The specification is 10 mL vial containing pertuzumab 600 mg and trastuzumab 600 mg, 1 vial per box. It is a prescription HER2-targeted anti-tumor monoclonal antibody covered by China’s Category B medical insurance.
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