{"id":"ql0605-peg-rhg-csf","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Bone pain"},{"rate":"5-15","effect":"Injection site reactions"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Fatigue"},{"rate":"5","effect":"Splenomegaly"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"G-CSF is a cytokine that binds to G-CSF receptors on hematopoietic progenitor cells, promoting their growth and maturation into functional neutrophils. The pegylation (attachment of polyethylene glycol) extends the drug's half-life, allowing for less frequent dosing compared to non-pegylated G-CSF. This results in sustained elevation of circulating neutrophils, reducing the duration and severity of chemotherapy-induced neutropenia.","oneSentence":"QL0605 is a pegylated recombinant human granulocyte colony-stimulating factor (G-CSF) that stimulates the proliferation and differentiation of neutrophil precursor cells to increase white blood cell production.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:03:27.880Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chemotherapy-induced neutropenia (CIN) in cancer patients"},{"name":"Severe chronic neutropenia"}]},"trialDetails":[{"nctId":"NCT06616571","phase":"PHASE4","title":"Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints","status":"RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2024-09-19","conditions":"Chemotherapy-Induced Febrile Neutropenia","enrollment":336}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":82,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"QL0605(PEG-rhG-CSF)","genericName":"QL0605(PEG-rhG-CSF)","companyName":"Qilu Pharmaceutical Co., Ltd.","companyId":"qilu-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"QL0605(PEG-rhG-CSF) is a small molecule used to treat Chemotherapy-Induced Febrile Neutropenia. It is administered as an injection, with its efficacy and safety being compared at different timepoints in a randomized, open-label study.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}