Description
Indication & Scope
EnNiTuo (Anbenitamab) is a recombinant bispecific antibody targeting two distinct epitopes of HER2. By simultaneously binding to different extracellular domains of HER2, it enhances receptor clustering, blocks HER2 signaling pathways, and promotes antitumor activity through immune-mediated mechanisms. It is indicated for HER2-positive advanced gastric cancer patients after prior trastuzumab-based therapy.
- Mechanism: Anbenitamab simultaneously binds to the ECD2 and ECD4 domains of HER2, inducing HER2 receptor clustering and internalization, resulting in stronger inhibition of HER2 signaling. Its Fc-mediated activity enhances antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), contributing to tumor cell elimination.
- Drug class:Recombinant humanized HER2-directed bispecific monoclonal antibody.
- Clinical use: Treatment of HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in combination with chemotherapy after failure of prior trastuzumab-containing therapy.
| Generic Name | Anbenitamab |
| Brand Name | EnNiTuo® |
| Ingredient | Each vial contains 360 mg anbenitamab in 14.4 mL. |
| Dosage Form | Solution for Injection. |
| Package | One vial (14.4mL). |
| Conditions Treated | Treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received at least one trastuzumab-containing treatment regimen, in combination with chemotherapy. |
| Taboos | Hypersensitivity to anbenitamab or to any component of the product. |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Refer to the approved package labeling. |
| Manufacturer | Shanghai JMT BioTechnology Co., Ltd. (a subsidiary of CSPC Pharmaceutical Group) |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20260036 |
| Date of Revision | 2026 |
| Shelf Life | Refer to the approved package labeling |
How to use ?
Recommended Dose: 30 mg/kg administered by intravenous infusion once every 3 weeks, in combination with chemotherapy, until disease progression or unacceptable toxicity.
Time: Administer once every 3 weeks according to the approved treatment regimen.
Instructions for use: Administer by intravenous infusion under the supervision of a healthcare professional, in combination with chemotherapy, according to the approved prescribing information.
Interaction: No formal drug interaction studies have been conducted. Anbenitamab is intended for use in combination with chemotherapy according to the approved prescribing information.
Side effects: The most common adverse reactions include anemia, leukopenia, neutropenia, diarrhea, fatigue, alopecia, decreased appetite, thrombocytopenia, and weight loss. The safety profile is generally consistent with chemotherapy, and no increased risk of interstitial lung disease or cardiac toxicity has been observed in clinical studies.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is the recommended dose of EnNiTuo?
The recommended dose is 30 mg/kg by intravenous infusion once every 3 weeks.
Who is eligible for EnNiTuo treatment?
It is indicated for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received at least one trastuzumab-containing treatment regimen.
How does Anbenitamab work?
It binds two different HER2 epitopes simultaneously, enhancing HER2 blockade and promoting immune-mediated tumor cell killing.
Does EnNiTuo increase the risk of interstitial lung disease (ILD)?
Clinical studies have not shown an increased risk of interstitial lung disease with EnNiTuo.
EnNiTuo® Anbenitamab | HER2-Positive Gastric Cancer Treatment | DengYueRX
INN: Anbenitamab
Indications: HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma after trastuzumab therapy.
Dosage Form: Solution for Injection
Strength: 360 mg (14.4 mL) / vial
