{"id":"hlx14","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":"HLX14 targets programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing the suppressive signal that tumors use to evade the immune system. By blocking PD-L1, the drug restores T-cell activation and proliferation, allowing the body's immune system to recognize and attack cancer cells more effectively. This mechanism is similar to other checkpoint inhibitors in the PD-L1/PD-1 pathway.","oneSentence":"HLX14 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and B7.1 to enhance anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:53.037Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Gastric cancer"},{"name":"Esophageal cancer"}]},"trialDetails":[{"nctId":"NCT04534582","phase":"PHASE1","title":"Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2020-11-03","conditions":"Healthy Male Volunteers","enrollment":252},{"nctId":"NCT05352516","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2022-06-17","conditions":"Postmenopausal","enrollment":514}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"HLX14","genericName":"HLX14","companyName":"Shanghai Henlius Biotech","companyId":"shanghai-henlius-biotech","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HLX14 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and B7.1 to enhance anti-tumor immune responses. Used for Non-small cell lung cancer, Gastric cancer, Esophageal cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}