{"id":"shr-a2009-aumolertinib","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Decreased appetite"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Aumolertinib irreversibly binds to and inhibits mutant EGFR, particularly EGFR exon 19 deletions, L858R point mutations, and the T790M resistance mutation that emerges during first- or second-generation EGFR-TKI treatment. By blocking EGFR signaling in cancer cells dependent on these mutations, it prevents downstream proliferation and survival pathways.","oneSentence":"Aumolertinib is a third-generation EGFR tyrosine kinase inhibitor that selectively targets EGFR mutations, including T790M resistance mutations, to inhibit tumor cell proliferation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:34:32.190Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer with EGFR T790M mutation after progression on prior EGFR-TKI therapy"},{"name":"Non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line and subsequent lines)"}]},"trialDetails":[{"nctId":"NCT07183189","phase":"PHASE3","title":"A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC","status":"RECRUITING","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","startDate":"2025-10-30","conditions":"Non-small Cell Lung Cancer","enrollment":576},{"nctId":"NCT06474455","phase":"PHASE1, PHASE2","title":"A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Hengrui Pharmaceutical Co., Ltd.","startDate":"2024-06","conditions":"Advanced Solid Tumors","enrollment":156},{"nctId":"NCT06092268","phase":"PHASE1, PHASE2","title":"A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors","status":"UNKNOWN","sponsor":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","startDate":"2023-10","conditions":"Advanced Solid Tumors","enrollment":270}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":96,"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-A2009 ; Aumolertinib","genericName":"SHR-A2009 ; Aumolertinib","companyName":"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","companyId":"suzhou-suncadia-biopharmaceuticals-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Aumolertinib is a third-generation EGFR tyrosine kinase inhibitor that selectively targets EGFR mutations, including T790M resistance mutations, to inhibit tumor cell proliferation. Used for Non-small cell lung cancer with EGFR T790M mutation after progression on prior EGFR-TKI therapy, Non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line and subsequent lines).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}