Camptosar® is the original international commercial brand name, while YimaiLin® is the domestic generic brand manufactured by Qilu Pharmaceutical. It is an injectable topoisomerase I inhibitor anti-tumor drug. It stabilizes the DNA-topoisomerase complex to induce DNA strand breaks and block tumor cell division, exerting broad-spectrum anti-tumor activity against digestive system malignancies.
Main Indications
First-line combined treatment of metastatic colorectal cancer with fluoropyrimidine drugs;
Second-line monotherapy for metastatic colorectal cancer after fluoropyrimidine treatment failure;
Combination chemotherapy for advanced small cell lung cancer and advanced gastric cancer.
Clinical Research
Global multicenter phase III pivotal trials fully validated its objective tumor remission rate in advanced colorectal cancer patients;
Head-to-head comparative trials confirmed superior long-term disease control when irinotecan was combined with fluoropyrimidine regimens;
Long-term follow-up cohort studies demonstrated prolonged overall survival in patients with metastatic gastrointestinal tumors receiving irinotecan-based chemotherapy;
Dose adjustment research identified balanced anti-tumor efficacy and gastrointestinal tolerability of the 40mg per 2mL specification;
Chinese domestic registration trials verified consistent anti-tumor activity and controllable adverse events for local advanced digestive tumor populations.
Common Side Effects
Common mild adverse reactions: Delayed diarrhea, nausea, vomiting, fatigue, alopecia and leukopenia;
Laboratory abnormalities: Neutropenia, anemia, transient mild elevation of liver transaminases;
Severe but uncommon risks: Severe cholinergic acute diarrhea, febrile neutropenia, severe gastrointestinal hemorrhage and severe hypersensitivity reactions.
Approval Status in China
Generic drug YimaiLin® (Irinotecan Hydrochloride Injection) obtained marketing approval in China in 2008, with the specification of 2mL:40mg, 6 vials per box. It is currently a prescription anti-tumor drug included in China’s Category B medical insurance catalogue.
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