Lonsurf® is the original global commercial brand name, and Suyuan® is its domestic generic brand manufactured by Qilu Pharmaceutical. It is an oral fixed-dose combined anti-tumor preparation. Trifluridine interferes with tumor DNA replication to inhibit cancer cell proliferation; tipiracil hydrochloride blocks trifluridine degradation to maintain effective blood drug concentration.
Main Indications
Treatment of metastatic colorectal cancer in adult patients who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy;
Treatment of metastatic gastric or gastroesophageal junction adenocarcinoma after failure of at least two lines of systemic chemotherapy.
Clinical Research
Global phase III pivotal trials fully validated its survival benefit for patients with pretreated metastatic colorectal and gastric cancer;
Head-to-head comparative trials confirmed superior disease control rate and overall survival compared with single-agent supportive care;
Long-term observational cohort studies demonstrated sustained tumor inhibition and predictable safety profile during continuous oral cycles;
Dose titration research verified balanced anti-tumor efficacy and hematological tolerability of the standard twice-daily dosing regimen;
Chinese domestic registration trials confirmed consistent anti-tumor activity and manageable adverse reactions for local late-stage gastrointestinal tumor patients.
Common Side Effects
Common mild adverse reactions: Fatigue, nausea, vomiting, diarrhea, decreased appetite and stomatitis;
Laboratory abnormalities: Neutropenia, anemia, thrombocytopenia and transient mild liver function index elevation;
Severe but uncommon risks: Severe myelosuppression, febrile neutropenia, severe gastrointestinal hemorrhage and severe hypersensitivity reactions.
Approval Status in China
Generic drug Suyuan® (Trifluridine and Tipiracil Hydrochloride Tablets) obtained marketing approval in China in 2020, with the specification of 15 mg trifluridine plus 7.065 mg tipiracil hydrochloride per tablet, 20 tablets per box. It is currently a prescription anti-tumor drug included in China’s Category B medical insurance catalogue.
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