{"id":"hlx13","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HLX13 is a humanized 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 activity, allowing the immune system to recognize and attack cancer cells more effectively. This mechanism is similar to other checkpoint inhibitors in the immuno-oncology space.","oneSentence":"HLX13 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":"2026-03-28T00:44:49.000Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Gastric cancer"},{"name":"Other solid tumors (in development)"}]},"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":"HLX13","genericName":"HLX13","companyName":"Shanghai Henlius Biotech","companyId":"shanghai-henlius-biotech","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HLX13 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, Gastric 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}}