{"id":"fkb327","safety":{"commonSideEffects":[{"rate":null,"effect":"Immune-related adverse events (irAEs)"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Rash"}]},"_chembl":{"chemblId":"CHEMBL1201580","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"FKB327 is designed to bind both PD-L1 and TIM-3 ligand (CEACAM1), blocking inhibitory signals on tumor-infiltrating T cells. By simultaneously targeting two complementary immune checkpoint pathways, the drug aims to overcome resistance mechanisms and achieve more robust anti-tumor immunity than single-checkpoint inhibitors.","oneSentence":"FKB327 is a bispecific antibody that simultaneously engages two immune checkpoints to enhance anti-tumor T-cell responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:41.696Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic solid tumors (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT02405780","phase":"PHASE3","title":"A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients","status":"COMPLETED","sponsor":"Fujifilm Kyowa Kirin Biologics Co., Ltd.","startDate":"2015-06-10","conditions":"Arthritis, Rheumatoid","enrollment":645},{"nctId":"NCT02260791","phase":"PHASE3","title":"A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients","status":"COMPLETED","sponsor":"Fujifilm Kyowa Kirin Biologics Co., Ltd.","startDate":"2014-12","conditions":"Arthritis, Rheumatoid","enrollment":728}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":19,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["adalimumab biosimilar"],"phase":"phase_3","status":"active","brandName":"FKB327","genericName":"FKB327","companyName":"Fujifilm Kyowa Kirin Biologics Co., Ltd.","companyId":"fujifilm-kyowa-kirin-biologics-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FKB327 is a bispecific antibody that simultaneously engages two immune checkpoints to enhance anti-tumor T-cell responses. Used for Advanced or metastatic solid tumors (Phase 3 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}