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This mechanism is particularly relevant in solid tumors with FGFR-dependent oncogenic drivers.","oneSentence":"HSK39297 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:46:08.592Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"FGFR-driven solid tumors (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT07052838","phase":"PHASE3","title":"Efficacy and Safety of HSK39297 in Anti-C5 Treated PNH Patients With Anemia","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2025-05-12","conditions":"Paroxysmal Nocturnal Haemoglobinuria (PNH)","enrollment":36},{"nctId":"NCT07390123","phase":"PHASE3","title":"Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN","status":"RECRUITING","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2026-02","conditions":"IgA Nephropathy (IgAN)","enrollment":370},{"nctId":"NCT07363460","phase":"PHASE2","title":"Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN","status":"RECRUITING","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2025-11-18","conditions":"Lupus Nephritis (LN)","enrollment":105},{"nctId":"NCT06799546","phase":"PHASE3","title":"A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2025-02-13","conditions":"PNH","enrollment":73},{"nctId":"NCT07152288","phase":"PHASE1","title":"Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment","status":"RECRUITING","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2025-05-29","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":24},{"nctId":"NCT06561841","phase":"PHASE2","title":"A Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria（PNH）","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2024-07-17","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":47},{"nctId":"NCT06852092","phase":"PHASE1","title":"Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2024-09-09","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":7},{"nctId":"NCT06350279","phase":"PHASE1","title":"A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2023-12-25","conditions":"Healthy","enrollment":96},{"nctId":"NCT06745622","phase":"PHASE2","title":"Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria","status":"RECRUITING","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2025-01-03","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":47},{"nctId":"NCT06670352","phase":"PHASE2","title":"Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgAN","status":"RECRUITING","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2024-10-12","conditions":"IgA Nephropathy (IgAN)","enrollment":80}],"_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":"HSK39297","genericName":"HSK39297","companyName":"Haisco Pharmaceutical Group Co., Ltd.","companyId":"haisco-pharmaceutical-group-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HSK39297 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells. Used for FGFR-driven solid tumors (Phase 3 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}