{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T23:07:56Z","timestamp":1784934476398,"version":"3.55.0"},"reference-count":31,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T00:00:00Z","timestamp":1762300800000},"content-version":"vor","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014471","name":"Mundipharma Research Limited","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014471","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Mycoses"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The global double\u2010blind, randomised, Phase 3 ReSTORE trial (NCT03667690) demonstrated noninferiority of rezafungin versus caspofungin for all\u2010cause mortality at Day 30 and global cure at Day 14 in patients with candidemia and\/or invasive candidiasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      We report outcomes for patients from China (ReSTORE China), comprising participants enrolled in the original ReSTORE trial (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200911) and from an extended, China\u2010only phase (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200947) implemented to fulfill Chinese regulatory requirements.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Patients with candidemia\/invasive candidiasis were randomised 1:1 to intravenous rezafungin (400\u2009mg loading, then 200\u2009mg once weekly) or caspofungin (70\u2009mg loading, then 50\u2009mg once daily) for \u2264\u20094\u2009weeks. Primary endpoints were all\u2010cause mortality at Day 30 and global cure at Day 14 in the modified intent\u2010to\u2010treat population. Between October 2018 and March 2024, 58 patients were randomised and received study treatment (rezafungin\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200928 [modified intent\u2010to\u2010treat\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200927], caspofungin\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200930 [modified intent\u2010to\u2010treat\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200928]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>All\u2010cause mortality at Day 30 was 33.3% (9\/27) for rezafungin versus 35.7% (10\/28) for caspofungin (difference \u22122.4% [95% confidence interval \u221227.0\u201322.6]). Global cure at Day 14 was 48.1% (13\/27) versus 46.4% (13\/28), respectively (weighted difference 0.3% [95% confidence interval \u221225.4\u201326.3]). Day 5 and 14 mycological eradication rates were 70.4% and 63.0% for rezafungin versus 71.4% and 67.9% for caspofungin, respectively. Safety and tolerability profiles were similar between groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Rezafungin demonstrated similar efficacy and safety to caspofungin in the ReSTORE China cohort. These findings support the primary ReSTORE analysis and suggest that rezafungin could provide a new treatment option for candidemia\/invasive candidiasis in China.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.clinicaltrials.org\">ClinicalTrials.gov<\/jats:ext-link>\n                      identifier: NCT03667690\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/myc.70122","type":"journal-article","created":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T06:30:18Z","timestamp":1762410618000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and Safety of Rezafungin Versus Caspofungin for the Treatment of Candidemia and Invasive Candidiasis in a China Cohort of a Double\u2010Blind, Randomised, Phase 3 Trial (\n                    <scp>ReSTORE<\/scp>\n                    China)"],"prefix":"10.1111","volume":"68","author":[{"given":"Haihui","family":"Huang","sequence":"first","affiliation":[{"name":"Institute of Antibiotics, Huashan Hospital, Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sizhou","family":"Feng","sequence":"additional","affiliation":[{"name":"Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College  Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2903-918X","authenticated-orcid":false,"given":"Yunsong","family":"Yu","sequence":"additional","affiliation":[{"name":"Sir Run Run Shaw Hospital of Zhejiang University School of Medicine  Hangzhou Zhejiang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yong","family":"Zhang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Bengbu Medical University  Bengbu Anhui China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan","family":"Yuan","sequence":"additional","affiliation":[{"name":"Gansu Provincial Hospital  Lanzhou Gansu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Cox","sequence":"additional","affiliation":[{"name":"Mundipharma Research Ltd  Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9564-2353","authenticated-orcid":false,"given":"Yingyuan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Institute of Antibiotics, Huashan Hospital, Fudan University  Shanghai 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