{"id":"hlx22","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"},{"rate":null,"effect":"Infusion reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HLX22 targets programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing the suppression of T-cell mediated anti-tumor immunity. By blocking the PD-L1/PD-1 axis, the drug allows the immune system to recognize and attack cancer cells more effectively. This mechanism is characteristic of checkpoint inhibitors used across multiple cancer types.","oneSentence":"HLX22 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":"2026-03-28T00:44:53.995Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Gastric cancer"},{"name":"Other solid tumors (in development)"}]},"trialDetails":[{"nctId":"NCT07294508","phase":"PHASE2, PHASE3","title":"A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2026-02-27","conditions":"HER2 + Breast Cancer","enrollment":706},{"nctId":"NCT06532006","phase":"PHASE3","title":"A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer","status":"RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2024-11-22","conditions":"Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer","enrollment":550},{"nctId":"NCT07294534","phase":"PHASE2, PHASE3","title":"A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2026-01-27","conditions":"HER2 + Breast Cancer","enrollment":817},{"nctId":"NCT07176702","phase":"PHASE2","title":"A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Shanghai Zhongshan Hospital","startDate":"2025-09-30","conditions":"Metastatic PDAC, HER2-positive Status","enrollment":45},{"nctId":"NCT06832202","phase":"PHASE2","title":"A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients","status":"RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2025-04-16","conditions":"HER2-low Hormone Receptor Positive Breast Cancer","enrollment":50},{"nctId":"NCT04908813","phase":"PHASE2","title":"Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2021-09-29","conditions":"Gastric Cancer","enrollment":150},{"nctId":"NCT03916094","phase":"PHASE1","title":"Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2019-07-31","conditions":"Solid Tumor","enrollment":11}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["HER2 Monoclonal Antibody"],"phase":"phase_3","status":"active","brandName":"HLX22","genericName":"HLX22","companyName":"Shanghai Henlius Biotech","companyId":"shanghai-henlius-biotech","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HLX22 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":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}