{"entity":{"id":"utidelone","kind":"drug","name":"Utidelone","aka":["Youheng"],"tldr":"Utidelone is Biostar Pharmaceuticals' epothilone chemotherapy, approved in China in 2021 with capecitabine for advanced breast cancer after anthracyclines and taxanes.","summary":"Utidelone is a genetically engineered epothilone analogue produced by fermentation, developed by Biostar Pharmaceuticals in Chengdu. The NMPA approved it in March 2021 in combination with capecitabine for recurrent or metastatic breast cancer previously treated with an anthracycline and a taxane, after a phase 3 trial showed longer progression-free and overall survival than capecitabine alone. An oral form is in later trials.","status":"approved","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov: trials of utidelone","url":"https://clinicaltrials.gov/search?intr=utidelone"}],"tags":["china","nmpa-approved"],"related":[],"cancers":[],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":["tubulin"],"drugs":[],"companies":["biostar-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo China deep dive","editedOn":"2026-09-16"},"code":"UTD1","modality":"Epothilone analogue, microtubule-stabilising cytotoxic chemotherapy","mechanism":"Binds tubulin and locks microtubules in place so that dividing cells cannot complete mitosis; it works in cells that have become resistant to taxanes.","approvals":[{"region":"CN","year":2021,"indication":"Recurrent or metastatic breast cancer after anthracycline and taxane, with capecitabine"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/utidelone/","neighbours":{"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"target":[{"id":"tubulin","kind":"target","name":"Tubulin (microtubules)","route":"/targets/tubulin/"}],"company":[{"id":"biostar-pharmaceuticals","kind":"company","name":"Biostar Pharmaceuticals","route":"/companies/biostar-pharmaceuticals/"}],"trial":[{"id":"nct06764940","kind":"trial","name":"A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases","route":"/trials/nct06764940/"},{"id":"nct07021261","kind":"trial","name":"Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients","route":"/trials/nct07021261/"},{"id":"nct05700084","kind":"trial","name":"Phase I-II Clinical Trial of Utidelone Capsule in Patients With Advanced Solid Tumors","route":"/trials/nct05700084/"},{"id":"nct06125080","kind":"trial","name":"The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ：Single-arm, Prospec","route":"/trials/nct06125080/"},{"id":"nct06385990","kind":"trial","name":"Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy","route":"/trials/nct06385990/"},{"id":"nct06683703","kind":"trial","name":"Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases","route":"/trials/nct06683703/"}]}}