{"id":"eu-sourced-yervoy","safety":{"commonSideEffects":[{"rate":"10–15","effect":"Immune-related colitis"},{"rate":"3–5","effect":"Immune-related hepatitis"},{"rate":"1–3","effect":"Immune-related pneumonitis"},{"rate":"5–10","effect":"Immune-related endocrinopathy (thyroiditis, hypophysitis)"},{"rate":"25–30","effect":"Rash"},{"rate":"20–25","effect":"Fatigue"},{"rate":"20–25","effect":"Diarrhea"}]},"_chembl":{"chemblId":"CHEMBL5857501","moleculeType":null,"molecularWeight":"542.39"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ipilimumab is a monoclonal antibody that binds to cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a negative regulator of T-cell activation. By blocking CTLA-4, the drug removes a 'brake' on the immune system, allowing T cells to proliferate and attack cancer cells more effectively. This checkpoint inhibitor approach has demonstrated clinical benefit across multiple solid and hematologic malignancies.","oneSentence":"YERVOY (ipilimumab) blocks CTLA-4 on T cells, removing an inhibitory signal and enhancing anti-tumor immune responses.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:46:27.774Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic melanoma"},{"name":"Advanced renal cell carcinoma"},{"name":"Metastatic colorectal cancer (microsatellite instability-high)"},{"name":"Hepatocellular carcinoma"}]},"trialDetails":[{"nctId":"NCT07176650","phase":"PHASE1","title":"Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma","status":"RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2025-11-25","conditions":"Hepatocellular Carcinoma (HCC)","enrollment":246},{"nctId":"NCT06841185","phase":"PHASE3","title":"A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2025-04-30","conditions":"Hepatocellular Carcinoma (HCC)","enrollment":656},{"nctId":"NCT06159101","phase":"PHASE1","title":"A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects","status":"UNKNOWN","sponsor":"Shanghai Henlius Biotech","startDate":"2023-11-28","conditions":"Healthy Male Volunteers","enrollment":304}],"_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":"EU-sourced YERVOY®","genericName":"EU-sourced YERVOY®","companyName":"Shanghai Henlius Biotech","companyId":"shanghai-henlius-biotech","modality":"Small molecule","firstApprovalDate":"","aiSummary":"YERVOY (ipilimumab) blocks CTLA-4 on T cells, removing an inhibitory signal and enhancing anti-tumor immune responses. Used for Metastatic melanoma, Advanced renal cell carcinoma, Metastatic colorectal cancer (microsatellite instability-high).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}