QINLOCK® is the original global commercial brand name, and Qingle is its Chinese brand name distributed by Zai Lab. It is an oral switch-control type multi-target tyrosine kinase inhibitor. It locks the inactive conformation of KIT and PDGFRα kinases, broadly inhibiting various primary and secondary resistant mutations of GIST to block tumor proliferation signals.
Main Indications
Treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior therapy with three or more kinase inhibitors including imatinib.
Clinical Research
Global multicenter phase III INVICTUS pivotal trial fully validated its significant progression-free survival and overall survival benefits versus placebo for fourth-line advanced GIST patients;
Head-to-head controlled registration trials confirmed durable tumor stabilization and objective remission rate in multi-line pretreated refractory GIST;
Long-term open-label extension follow-up cohorts demonstrated sustained disease control under continuous once-daily oral administration;
Dose-finding research verified balanced anti-tumor efficacy and systemic safety profile of the 150mg once-daily standard regimen;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reactions for local multi-line resistant GIST populations.
Common Side Effects
Common mild adverse reactions: Alopecia, fatigue, nausea, abdominal pain, constipation and myalgia;
Laboratory abnormalities: Transient mild elevation of liver transaminases, increased creatine phosphokinase and hypophosphatemia;
Severe but uncommon risks: Severe cutaneous toxicity, grade 3–4 hypertension, severe gastrointestinal perforation and cardiac dysfunction.
Approval Status in China
Original drug QINLOCK® (Chinese brand: Qingle) was officially approved for marketing in China in March 2021, with the specification of 50mg per tablet, 30 tablets per bottle. It is currently a prescription targeted anti-tumor drug included in China’s Category B medical insurance catalogue.
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