{"id":5014,"date":"2026-04-16T08:00:00","date_gmt":"2026-04-16T00:00:00","guid":{"rendered":"https:\/\/www.sinotau.com\/?p=5014"},"modified":"2026-06-08T16:20:06","modified_gmt":"2026-06-08T08:20:06","slug":"nmpa-accepted-ind-application-for-xtr021-an-innovative-radiopharmaceutical","status":"publish","type":"post","link":"https:\/\/www.sinotau.com\/en\/2026\/04\/nmpa-accepted-ind-application-for-xtr021-an-innovative-radiopharmaceutical\/","title":{"rendered":"NMPA Accepted IND Application for XTR021, an Innovative Radiopharmaceutical"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Sinotau is pleased to announce that the Investigational New Drug (IND) application for XTR021, a Class 1 innovative radiopharmaceutical developed in-house, has been accepted by the National Medical Products Administration (NMPA).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">XTR021 is a 177Lu-labeled, PSMA-targeted radioligand for the treatment of prostate cancer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Preclinical studies demonstrate that, owing to its novel molecular design, XTR021 exhibits higher cellular internalization and retention, as well as improved tumor uptake, compared with 177Lu-PSMA-617. Notably, XTR021 achieves superior tumor inhibition at significantly lower doses than 177Lu-PSMA-617.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Interim data from an investigator-initiated trial (IIT) in patients with metastatic castration-resistant prostate cancer (mCRPC) indicate a favorable safety profile, with no observed Grade 3 or higher adverse events or salivary gland toxicity. In terms of efficacy, XTR021 demonstrates a rapid and encouraging PSA50 response rate. Based on cross-trial comparisons, currently available data suggest that XTR021 may offer enhanced therapeutic efficacy and an improved safety profile relative to comparable international compounds, underscoring its potential as a next-generation radioligand therapy for prostate cancer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Abbreviations: PSMA, prostate-specific membrane antigen; PSA, prostate-specific antigen; mCRPC, metastatic castration-resistant prostate cancer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sinotau is pleased to announce that the Investigational New Drug (IND) application for XTR021, a Class 1 innovative radiopharmaceutical developed in-house, has been accepted by the National Medical Products Administration (NMPA). XTR021 is a 177Lu-labeled, PSMA-targeted radioligand for the treatment of prostate cancer. Preclinical studies demonstrate that, owing to its novel molecular design, XTR021 exhibits [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[],"class_list":["post-5014","post","type-post","status-publish","format-standard","hentry","category-company-news"],"meta_box":[],"_links":{"self":[{"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/posts\/5014","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/comments?post=5014"}],"version-history":[{"count":1,"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/posts\/5014\/revisions"}],"predecessor-version":[{"id":5016,"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/posts\/5014\/revisions\/5016"}],"wp:attachment":[{"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/media?parent=5014"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/categories?post=5014"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.sinotau.com\/en\/wp-json\/wp\/v2\/tags?post=5014"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}