{"entity":{"id":"hrs-8080","kind":"drug","name":"HRS-8080","aka":[],"tldr":"HRS-8080 is an experimental small-molecule drug from Shandong Suncadia Medicine in phase 3 trials for HR-positive / HER2-negative breast cancer, with its target not yet stated publicly.","summary":"HRS-8080 is a small-molecule drug developed by Shandong Suncadia Medicine. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. ClinicalTrials.gov describes the intervention as: * HRS-8080 Tablet * Dalpiciclib Isethionate. It is the investigational product in 5 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT07354022 (A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy), NCT07024173 (A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer) and NCT07349069 (A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer), in HR-positive / HER2-negative breast cancer. The largest, NCT07349069, plans to enrol 5500 participants with primary completion expected 2030-12. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of HRS-8080","url":"https://clinicaltrials.gov/search?intr=HRS-8080"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07354022","nct07024173","nct07349069","nct06222879","nct06679036","nct06555068","nct07389733","nct06167694"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"small molecule (structure undisclosed or not yet in PubChem)","mechanism":"Mechanism not stated in the ClinicalTrials.gov record or on the sponsor's pipeline page.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/hrs-8080/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"company":[{"id":"hengrui","kind":"company","name":"Jiangsu Hengrui Pharmaceuticals","route":"/companies/hengrui/"}],"trial":[{"id":"nct07024173","kind":"trial","name":"A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer","route":"/trials/nct07024173/"},{"id":"nct07349069","kind":"trial","name":"A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer","route":"/trials/nct07349069/"},{"id":"nct07389733","kind":"trial","name":"A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer","route":"/trials/nct07389733/"},{"id":"nct07354022","kind":"trial","name":"A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy","route":"/trials/nct07354022/"},{"id":"nct06679036","kind":"trial","name":"A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients","route":"/trials/nct06679036/"},{"id":"nct06555068","kind":"trial","name":"A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients","route":"/trials/nct06555068/"},{"id":"nct06167694","kind":"trial","name":"Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer","route":"/trials/nct06167694/"},{"id":"nct06222879","kind":"trial","name":"Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer","route":"/trials/nct06222879/"}]}}