Enzeshu Suvemcitug for Injection

1. Indications and Usage
Ovarian Cancer:
Treatment of adult patients with platinum-resistant or platinum-refractory epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, in combination with chemotherapy (e.g., liposomal doxorubicin, topotecan) .
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY.
Recommended Dosage:
Standard Dose: 50 mg per administration.
Frequency: Administered once every 2 weeks (Q2W).
Critical Administration Instructions:
Preparation: Must be prepared by qualified personnel under aseptic conditions. Do not shake vigorously.
Dilution: Dilute the required dose in 100 mL of 0.9% Sodium Chloride Injection.
Infusion Time: Administer over approximately 60 minutes.
Line Clearance: Use a separate infusion line; if using a Y-site, flush with 0.9% Sodium Chloride before and after infusion. Do not co-administer with other drugs.
3. Mechanism of Action
VEGF Neutralization:
Suvemcitug is a humanized IgG1 monoclonal antibody that specifically binds to and neutralizes VEGF-A.
Anti-angiogenesis:
By inhibiting VEGF signaling, it blocks tumor angiogenesis (formation of new blood vessels), thereby starving the tumor of nutrients and oxygen, and potentiating the effect of concurrent chemotherapy .
4. Safety and Warnings
Gastrointestinal Perforation and Fistulas:
Serious and fatal GI perforations and fistulas have been reported. Monitor patients closely and discontinue if these occur .
Hemorrhage:
Increased risk of bleeding events (e.g., epistaxis). Severe hemorrhage has been reported .
Hypertension:
Monitor blood pressure regularly. Manage hypertension according to clinical guidelines.
Proteinuria and Nephrotoxicity:
Monitor urine protein levels. Discontinue for severe proteinuria (e.g., >2 g/24h) .
Arterial Thromboembolism:
Monitor for signs and symptoms of arterial thromboembolism (e.g., myocardial infarction, stroke).
5.Adverse Reactions and Clinical Research
Most Common Adverse Reactions:
Neutropenia, leukopenia, thrombocytopenia, proteinuria, hypertension, hyperlipidemia, elevated ALT/AST, and bleeding events .
Clinical Research Highlights:
In the Phase 3 SM-63-OC-301 study, the addition of suvemcitug to chemotherapy demonstrated significantly improved efficacy compared to chemotherapy alone in platinum-resistant ovarian cancer .
6.Drug Interactions
CYP450 System:
Suvemcitug is a large protein molecule and is not expected to interact with CYP450 enzymes.
Chemotherapy Agents:
Generally administered in combination with chemotherapy (e.g., topotecan, liposomal doxorubicin). Dose adjustments may be required based on the concomitant chemotherapy regimen.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Suvemcitug (Recombinant humanized monoclonal antibody).
Appearance: White to off-white lyophilized powder or cake.
Packaging: Single-use vial (50 mg).
Storage: Store in the original carton at 2°C to 8°C. Do not freeze.