{"id":"bcd-057","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCD-057 is a fully human monoclonal antibody designed to target programmed death ligand 1 (PD-L1) on tumor cells and immune cells. By blocking the PD-L1/PD-1 axis, the drug prevents tumor cells from suppressing T-cell activity, thereby reinvigorating the immune system's ability to recognize and eliminate cancer cells. This mechanism is similar to other checkpoint inhibitors in the immuno-oncology space.","oneSentence":"BCD-057 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:47.216Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (under investigation)"}]},"trialDetails":[{"nctId":"NCT07181694","phase":"PHASE1","title":"A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects","status":"RECRUITING","sponsor":"Biocad","startDate":"2025-03-12","conditions":"Healthy Adult Male","enrollment":444},{"nctId":"NCT02395055","phase":"PHASE1","title":"Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers","status":"COMPLETED","sponsor":"Biocad","startDate":"2015-06","conditions":"Healthy","enrollment":94},{"nctId":"NCT02762955","phase":"PHASE3","title":"Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis","status":"COMPLETED","sponsor":"Biocad","startDate":"2016-12","conditions":"Psoriasis","enrollment":344}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["adalimumab"],"phase":"phase_3","status":"active","brandName":"BCD-057","genericName":"BCD-057","companyName":"Biocad","companyId":"biocad","modality":"Biologic","firstApprovalDate":"","aiSummary":"BCD-057 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses. Used for Non-small cell lung cancer, Other solid tumors (under investigation).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}