{"entity":{"id":"dalpiciclib","kind":"drug","name":"Dalpiciclib","aka":[],"tldr":"Dalpiciclib is Hengrui's CDK4/6 inhibitor, the first China-developed drug of the class, approved for hormone-driven advanced breast cancer on the DAWNA trials.","summary":"DAWNA-1 (361 patients, Nature Medicine 2021) showed median progression-free survival of 15.7 versus 7.2 months when dalpiciclib was added to fulvestrant after endocrine therapy (hazard ratio 0.42), the basis of NMPA approval in December 2021; DAWNA-2 with an aromatase inhibitor in the first line followed in 2023. Neutropenia is frequent, as with palbociclib. It gives Chinese patients a reimbursed domestic alternative to imported CDK4/6 inhibitors.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Dalpiciclib","links":[{"label":"Jiangsu Hengrui Pharmaceuticals","url":"https://www.hengrui.com/en/"},{"label":"DAWNA-1 (Nat Med 2021)","url":"https://doi.org/10.1038/s41591-021-01562-9"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor","kinase-inhibitors"],"targets":["cdk4-6"],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":["p53-cell-cycle"],"terms":[],"trials":["dawna-1","nct04842617","nct06167694"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Airuikang","code":"SHR6390","modality":"Small-molecule CDK4/6 inhibitor","mechanism":"Selective inhibitor of cyclin-dependent kinases 4 and 6, preventing RB phosphorylation and G1 to S progression in hormone receptor-positive breast cancer.","approvals":[{"region":"China","year":2021,"indication":"HR-positive, HER2-negative advanced breast cancer with fulvestrant after endocrine therapy (DAWNA-1)"},{"region":"China","year":2023,"indication":"First-line HR-positive, HER2-negative advanced breast cancer with an aromatase inhibitor (DAWNA-2)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/dalpiciclib/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"cdk46-inhibitor","kind":"technology","name":"CDK4/6 inhibitors","route":"/technologies/cdk46-inhibitor/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"cdk4-6","kind":"target","name":"CDK4/6","route":"/targets/cdk4-6/"}],"company":[{"id":"hengrui","kind":"company","name":"Jiangsu Hengrui Pharmaceuticals","route":"/companies/hengrui/"}],"pathway":[{"id":"p53-cell-cycle","kind":"pathway","name":"p53 / RB / cell-cycle checkpoint","route":"/pathways/p53-cell-cycle/"}],"trial":[{"id":"nct06208410","kind":"trial","name":"A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors","route":"/trials/nct06208410/"},{"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":"dawna-1","kind":"trial","name":"DAWNA-1","route":"/trials/dawna-1/"},{"id":"nct05463601","kind":"trial","name":"Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer","route":"/trials/nct05463601/"},{"id":"nct04842617","kind":"trial","name":"Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Ne","route":"/trials/nct04842617/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}