{"id":"bat8001-for-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Cytokine release syndrome"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Immune-related adverse events"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BAT8001 functions as a bispecific monoclonal antibody designed to bridge tumor cells and immune cells, typically by binding to a tumor-associated antigen on one arm and an immune checkpoint or activating receptor on the other. This dual engagement enhances T-cell activation, recruitment, and cytotoxic killing of cancer cells. The bispecific format allows for improved tumor targeting and immune cell engagement compared to conventional monospecific antibodies.","oneSentence":"BAT8001 is a bispecific antibody that simultaneously engages tumor-associated antigens and immune effector cells to enhance anti-tumor immunity.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:03:40.740Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Solid tumors (specific indications under investigation in phase 3 trials)"}]},"trialDetails":[{"nctId":"NCT04189211","phase":"PHASE1","title":"A Clinical Trial of BAT8001 on Safety, Tolerability and Pharmacokinetics for Patients","status":"UNKNOWN","sponsor":"Bio-Thera Solutions","startDate":"2017-03-07","conditions":"HER2-Positive Solid Tumors","enrollment":30},{"nctId":"NCT04185649","phase":"PHASE3","title":"The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer","status":"UNKNOWN","sponsor":"Bio-Thera Solutions","startDate":"2018-07-01","conditions":"HER2-positive Advanced Breast Cancer","enrollment":410},{"nctId":"NCT04151329","phase":"PHASE1, PHASE2","title":"A Phase I Clinical Trial of BAT1306 and BAT8001 Injection in Patients With Solid Tumor","status":"UNKNOWN","sponsor":"Bio-Thera Solutions","startDate":"2019-06-21","conditions":"Solid Tumor","enrollment":72}],"_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":[],"phase":"phase_3","status":"active","brandName":"BAT8001 for injection","genericName":"BAT8001 for injection","companyName":"Bio-Thera Solutions","companyId":"bio-thera-solutions","modality":"Biologic","firstApprovalDate":"","aiSummary":"BAT8001 is an injection being studied in a Phase I clinical trial for the treatment of HER2-positive Advanced Breast Cancer and HER2-Positive Solid Tumors. The exact mechanism of BAT8001 is unknown.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}