{"id":"bcd-148","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"},{"rate":null,"effect":"Infusion reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCD-148 is a fully human monoclonal antibody targeting programmed death ligand 1 (PD-L1) on tumor cells and immune cells. By blocking the PD-L1/PD-1 axis, it prevents the suppression of T-cell mediated anti-tumor immunity, allowing the immune system to recognize and eliminate cancer cells. This mechanism is similar to other checkpoint inhibitors in the immuno-oncology space.","oneSentence":"BCD-148 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":"2026-03-28T01:00:31.050Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (under investigation)"}]},"trialDetails":[{"nctId":"NCT06987864","phase":"PHASE3","title":"An Extension Clinical Study of BCD-148 for the Treatment of Patients With PNH Previously Treated in Clinical Study No. BCD-148-2/NOCTURN","status":"COMPLETED","sponsor":"Biocad","startDate":"2020-04-13","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":24},{"nctId":"NCT04060264","phase":"PHASE3","title":"Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria","status":"COMPLETED","sponsor":"Biocad","startDate":"2019-04-04","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":28},{"nctId":"NCT04027803","phase":"PHASE1","title":"Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®","status":"COMPLETED","sponsor":"Biocad","startDate":"2018-09-21","conditions":"Healthy Subjects","enrollment":78}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["eculizumab"],"phase":"phase_3","status":"active","brandName":"BCD-148","genericName":"BCD-148","companyName":"Biocad","companyId":"biocad","modality":"Biologic","firstApprovalDate":"","aiSummary":"BCD-148 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":1,"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}