{"id":4352,"date":"2026-06-16T09:54:05","date_gmt":"2026-06-16T16:54:05","guid":{"rendered":"https:\/\/xpharma.com.cn\/?p=4352"},"modified":"2026-06-16T09:54:06","modified_gmt":"2026-06-16T16:54:06","slug":"hengrui%ef%bc%9adalpiciclib-was-approved","status":"publish","type":"post","link":"https:\/\/xpharma.com.cn\/index.php\/news\/hengrui%ef%bc%9adalpiciclib-was-approved\/","title":{"rendered":"Hengrui\uff1aDalpiciclib was approved"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">On June 15, the NMPA official website announced that Hengrui Medicine&#8217;s self-developed CDK4\/6 inhibitor, Dalpiciclib Hydrochloride Tablets, has been approved for a new indication. The new indication is for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early or locally advanced breast cancer, in combination with endocrine therapy&nbsp;<a href=\"https:\/\/finance.sina.com.cn\/stock\/relnews\/cn\/2026-06-16\/doc-inicrivm7508435.shtml\"><\/a><a href=\"https:\/\/finance.eastmoney.com\/a\/202606163773356645.html\"><\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This approval is based on the positive results from the DAWNA-A trial, a multicenter, randomized, double-blind Phase III study evaluating Dalpiciclib plus endocrine therapy as an adjuvant treatment in HR-positive, HER2-negative breast cancer&nbsp;<a href=\"https:\/\/finance.sina.com.cn\/stock\/relnews\/cn\/2026-06-16\/doc-inicrivm7508435.shtml\"><\/a><a href=\"https:\/\/www.pharnexcloud.com\/zixun\/shiye\/lcyj_89878\"><\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The DAWNA-A study enrolled over 5,000 subjects, randomized 1:1 to receive Dalpiciclib plus endocrine therapy or placebo plus endocrine therapy. The primary endpoint was Invasive Disease-Free Survival (iDFS)&nbsp;<a href=\"https:\/\/finance.sina.com.cn\/stock\/relnews\/cn\/2026-06-16\/doc-inicrivm7508435.shtml\"><\/a><a href=\"https:\/\/www.hengrui.com\/media\/detail-770.html\"><\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">At the 2025 ASCO Annual Meeting, Hengrui presented the pre-specified first interim analysis of DAWNA-A&nbsp;<a href=\"https:\/\/www.hengrui.com\/media\/detail-779.html\"><\/a><a href=\"https:\/\/www.pharnexcloud.com\/zixun\/shiye\/lcyj_89878\"><\/a>. With a median follow-up of 20.3 months at data cutoff, results showed that Dalpiciclib plus endocrine therapy significantly prolonged iDFS compared to placebo plus endocrine therapy (HR 0.56, 95% CI 0.43\u20130.71; one-sided P&lt;0.0001), with a 4.5% absolute iDFS benefit at 2 years&nbsp;<a href=\"https:\/\/www.hengrui.com\/media\/detail-779.html\"><\/a><a href=\"https:\/\/finance.sina.com.cn\/stock\/relnews\/cn\/2026-06-16\/doc-inicrivm7508435.shtml\"><\/a><a href=\"##\"><\/a>. The iDFS benefit was generally consistent across stratification factors and baseline subgroups. Disease-Free Survival (DFS) and Distant Disease-Free Survival (DDFS) also favored the Dalpiciclib combination over placebo&nbsp;<a href=\"https:\/\/www.hengrui.com\/media\/detail-779.html\"><\/a><a href=\"https:\/\/www.pharnexcloud.com\/zixun\/shiye\/lcyj_89878\"><\/a>. The safety profile of Dalpiciclib was generally manageable&nbsp;<a href=\"https:\/\/www.hengrui.com\/media\/detail-779.html\"><\/a><a href=\"https:\/\/finance.sina.com.cn\/stock\/relnews\/cn\/2026-06-16\/doc-inicrivm7508435.shtml\"><\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dalpiciclib is an oral, selective small-molecule CDK4\/6 inhibitor independently developed by Hengrui Medicine, and is the first novel highly selective CDK4\/6 inhibitor independently developed in China&nbsp;<a href=\"https:\/\/www.hengrui.com\/media\/detail-779.html\"><\/a><a href=\"https:\/\/finance.sina.com.cn\/stock\/relnews\/cn\/2026-06-16\/doc-inicrivm7508435.shtml\"><\/a>. Prior to this approval, it had received NMPA approval for two indications: (1) in combination with fulvestrant for HR-positive, HER2-negative breast cancer that has progressed after endocrine therapy; and (2) in combination with an aromatase inhibitor as initial therapy for HR-positive, HER2-negative locally advanced or metastatic breast cancer. This is the third indication approved for this drug&nbsp;<a href=\"https:\/\/finance.sina.com.cn\/stock\/relnews\/cn\/2026-06-16\/doc-inicrivm7508435.shtml\"><\/a><a href=\"https:\/\/www.hengrui.com\/media\/detail-770.html\"><\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Buy <strong>Dalpiciclib<\/strong><strong>&nbsp;<\/strong>from China and save up to 80% on costs . no insurance needed . compare prices from a certified HongKong pharmacy .with fast shipping. Contact us now on WhatsApp to get the latest prices.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On June 15, the NMPA official website announced that Hengrui Medicine&#8217;s self-developed CDK4\/6 inhibitor, Dalpiciclib Hydrochloride Tablets, has been approved for a new indication. The new indication is for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early or locally advanced breast cancer, in combination with endocrine therapy&nbsp;. This [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":3381,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-4352","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"blocksy_meta":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Hengrui\uff1aDalpiciclib was approved - Xpharma China<\/title>\n<meta name=\"description\" content=\"Hengrui\uff1aDalpiciclib was approved - Xpharma China\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/xpharma.com.cn\/index.php\/news\/hengrui\uff1adalpiciclib-was-approved\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui\uff1aDalpiciclib was approved - 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