Herceptin® is the commercial brand name of Trastuzumab for Injection, a recombinant humanized monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2). It binds selectively to HER2 on tumor cell surface, inhibits HER2-mediated signaling, triggers antibody-dependent cellular cytotoxicity and suppresses tumor proliferation.
Main Indications
Treatment of HER2-positive early breast cancer;
Treatment of HER2-positive metastatic breast cancer;
Treatment of HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
Clinical Research
The pivotal NSABP B-31 and NCCTG N9831 trials demonstrated that adjuvant trastuzumab significantly improved disease-free and overall survival in HER2-positive early breast cancer;
The ToGA study confirmed survival benefit for trastuzumab combined with chemotherapy in HER2-positive advanced gastric cancer;
Chinese domestic registration trials validated efficacy and tolerability in local HER2-positive cancer patients.
Common Side Effects
Severe but important risks: Cardiac dysfunction including congestive heart failure, severe infusion reactions, pulmonary toxicity;
Common mild adverse reactions: Fever, chills, diarrhea, nausea, asthenia, rash, headache and infection.
Approval Status in China
Original drug Herceptin® (Trastuzumab for Injection, specification:440mg per vial) was officially approved for marketing in China in 2002. It is currently a prescription anti-tumor monoclonal antibody.
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