{"id":"shr-1209","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-related reactions"}]},"_chembl":{"chemblId":"CHEMBL5095381","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SHR-1209 binds to programmed death ligand-1 (PD-L1) on tumor cells and immune cells, preventing its engagement with PD-1 and B7-1 receptors on T cells. This blockade reverses the immunosuppressive tumor microenvironment, allowing T cells to recognize and attack cancer cells more effectively. The drug is designed to restore anti-tumor immunity in patients with PD-L1-expressing malignancies.","oneSentence":"SHR-1209 is a humanized monoclonal antibody that blocks the interaction between PD-L1 and its receptors (PD-1 and B7-1) to enhance anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:34:24.770Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (under investigation in Phase 3)"}]},"trialDetails":[{"nctId":"NCT06837077","phase":"PHASE1","title":"Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers","status":"ACTIVE_NOT_RECRUITING","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2025-03-14","conditions":"Hypercholesterolemia and Hyperlipidemia","enrollment":46},{"nctId":"NCT04885218","phase":"PHASE3","title":"Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2021-07-30","conditions":"Non-familial Hypercholesterolemia, Mixed Hyperlipidemia","enrollment":692},{"nctId":"NCT04849000","phase":"PHASE3","title":"Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2021-04-23","conditions":"Primary Hypercholesterolemia, Mixed Hyperlipemia","enrollment":709},{"nctId":"NCT04844125","phase":"PHASE3","title":"SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2021-04-14","conditions":"Primary Hypercholesterolemia","enrollment":144},{"nctId":"NCT05370950","phase":"PHASE1","title":"Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2022-05-25","conditions":"Hypercholesterolemia and Hyperlipidemia","enrollment":159},{"nctId":"NCT03944109","phase":"PHASE1, PHASE2","title":"The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2019-06-20","conditions":"Hyperlipidemia","enrollment":110},{"nctId":"NCT03634436","phase":"PHASE1","title":"The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2018-08-30","conditions":"Hypercholesteremia","enrollment":32},{"nctId":"NCT04455581","phase":"PHASE2","title":"A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2020-09-01","conditions":"Familial Hypercholesterolemia","enrollment":8}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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":"SHR-1209","genericName":"SHR-1209","companyName":"Jiangsu HengRui Medicine Co., Ltd.","companyId":"jiangsu-hengrui-medicine-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SHR-1209 is a humanized monoclonal antibody that blocks the interaction between PD-L1 and its receptors (PD-1 and B7-1) to enhance anti-tumor immune responses. Used for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":5,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}