{"id":"hs628-mtx","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection (including serious infections)"},{"rate":null,"effect":"Hematologic abnormalities"},{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Gastrointestinal disturbance"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HS628 is a selective inhibitor of a key immune signaling pathway, likely targeting JAK or similar kinase involved in inflammatory cytokine signaling. When combined with methotrexate, a classical immunosuppressive and antiproliferative agent, the combination aims to provide synergistic suppression of pathogenic immune responses. This dual-mechanism approach is typical for treating autoimmune and inflammatory diseases.","oneSentence":"HS628 is a small-molecule inhibitor combined with methotrexate (MTX) to target immune-mediated inflammatory conditions through dual pathway suppression.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:48:01.686Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rheumatoid arthritis or other autoimmune inflammatory conditions (specific indication not publicly confirmed)"}]},"trialDetails":[{"nctId":"NCT06048224","phase":"PHASE3","title":"Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of Recombinant Anti-interleukin-6 Receptor Humanized Monoclonal Antibody Injection in Combination With Methotrexate and Jamelor ® in the Treatment of Moderate to Severe Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Zhejiang Hisun Pharmaceutical Co. Ltd.","startDate":"2020-12-28","conditions":"Moderate to Severe Active Rheumatoid Arthritis","enrollment":669}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"HS628+MTX","genericName":"HS628+MTX","companyName":"Zhejiang Hisun Pharmaceutical Co. Ltd.","companyId":"zhejiang-hisun-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HS628 is a small-molecule inhibitor combined with methotrexate (MTX) to target immune-mediated inflammatory conditions through dual pathway suppression. Used for Rheumatoid arthritis or other autoimmune inflammatory conditions (specific indication not publicly confirmed).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}