{"id":"bat1806","safety":{"commonSideEffects":[{"rate":null,"effect":"Immune-related adverse events (irAEs)"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Infusion reactions"}]},"_chembl":{"chemblId":"CHEMBL1237022","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By blocking PD-1, BAT1806 relieves immune checkpoint inhibition on T cells. Simultaneously, its binding to TGF-β neutralizes an immunosuppressive cytokine abundant in tumors, further promoting T cell activation and infiltration. This dual mechanism aims to overcome resistance to single-agent PD-1 inhibition.","oneSentence":"BAT1806 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TGF-β in the tumor microenvironment to enhance anti-tumor immunity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:29.731Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (in development)"}]},"trialDetails":[{"nctId":"NCT06262477","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants","status":"COMPLETED","sponsor":"Biogen","startDate":"2024-01-02","conditions":"Healthy Volunteer","enrollment":300},{"nctId":"NCT05968508","phase":"PHASE1","title":"A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects","status":"COMPLETED","sponsor":"Bio-Thera Solutions","startDate":"2023-08-29","conditions":"Healthy Men","enrollment":300},{"nctId":"NCT03606876","phase":"PHASE1","title":"Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects","status":"COMPLETED","sponsor":"Bio-Thera Solutions","startDate":"2018-06-13","conditions":"Rheumatoid Arthritis","enrollment":138},{"nctId":"NCT03830203","phase":"PHASE3","title":"Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate","status":"COMPLETED","sponsor":"Bio-Thera Solutions","startDate":"2018-12-19","conditions":"Rheumatoid Arthritis","enrollment":621}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"ALANINE AMINOTRANSFERASE INCREASED"},{"count":1,"reaction":"ASPARTATE AMINOTRANSFERASE INCREASED"},{"count":1,"reaction":"HYPERTRIGLYCERIDAEMIA"},{"count":1,"reaction":"HYPERURICAEMIA"},{"count":1,"reaction":"NEUTROPHIL COUNT DECREASED"},{"count":1,"reaction":"WHITE BLOOD CELL COUNT DECREASED"}],"_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":["Actemra(EU-licensed)","Actemra(US-licensed)"],"phase":"phase_3","status":"active","brandName":"BAT1806","genericName":"BAT1806","companyName":"Bio-Thera Solutions","companyId":"bio-thera-solutions","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BAT1806 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TGF-β in the tumor microenvironment to enhance anti-tumor immunity. Used for Non-small cell lung cancer, Other solid tumors (in development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}