{"id":"ins068-injection","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":"CHEMBL2108760","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting the PD-L1/PD-1 axis, INS068 removes the immunosuppressive signal that tumors use to evade T-cell recognition and killing. This checkpoint inhibition allows cytotoxic T lymphocytes to recognize and eliminate cancer cells more effectively. The drug is designed to enhance endogenous anti-tumor immunity across multiple cancer types.","oneSentence":"INS068 is an anti-PD-L1 monoclonal antibody that blocks the interaction between PD-L1 on tumor cells and PD-1/B7.1 on immune cells, thereby restoring anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:16:16.933Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (under investigation in Phase 3)"}]},"trialDetails":[{"nctId":"NCT05702073","phase":"PHASE3","title":"To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2023-03-31","conditions":"Type 2 Diabetes Mellitus","enrollment":423},{"nctId":"NCT05699408","phase":"PHASE3","title":"To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2023-03-31","conditions":"Type 2 Diabetes","enrollment":513},{"nctId":"NCT05887895","phase":"PHASE1","title":"To Compare the Pharmacokinetics and Pharmacodynamics of HR20014, INS068 and INS062 After Single Subcutaneous Injection in Healthy Subjects","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2023-05-23","conditions":"Diabetes","enrollment":12},{"nctId":"NCT05336071","phase":"PHASE1","title":"The Relative Bioavailability of INS068 Injection With Two Different Formulations in Healthy Subjects","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2022-05-12","conditions":"Diabetes Mellitus","enrollment":24},{"nctId":"NCT05333835","phase":"PHASE2","title":"A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes","status":"UNKNOWN","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2022-07-08","conditions":"Type 2 Diabetes","enrollment":455},{"nctId":"NCT04663282","phase":"PHASE2","title":"A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2021-02-04","conditions":"Type 2 Diabetes","enrollment":179},{"nctId":"NCT05031871","phase":"PHASE1","title":"Pharmacokinetics of HR17031 Injection in Healthy Subjects","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2021-09-02","conditions":"Type 2 Diabetes Mellitus","enrollment":24}],"_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":"INS068 injection","genericName":"INS068 injection","companyName":"Jiangsu HengRui Medicine Co., Ltd.","companyId":"jiangsu-hengrui-medicine-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"INS068 is an anti-PD-L1 monoclonal antibody that blocks the interaction between PD-L1 on tumor cells and PD-1/B7.1 on immune cells, thereby restoring anti-tumor immune responses. Used for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}